{"protocolSection":{"identificationModule":{"nctId":"NCT04183205","orgStudyIdInfo":{"id":"MHBB-028-17F"},"organization":{"fullName":"VA Office of Research and Development","class":"FED"},"briefTitle":"Predicting SSRI Efficacy in Veterans With PTSD","officialTitle":"An Electrophysiological Predictor of SSRI Response in Veterans With PTSD","acronym":"SSRI"},"statusModule":{"statusVerifiedDate":"2026-05","overallStatus":"TERMINATED","whyStopped":"difficulty meeting recruitment goals","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-09-11","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-03-30","type":"ACTUAL"},"completionDateStruct":{"date":"2025-03-31","type":"ACTUAL"},"studyFirstSubmitDate":"2019-11-27","studyFirstSubmitQcDate":"2019-11-27","studyFirstPostDateStruct":{"date":"2019-12-03","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-03-24","resultsFirstSubmitQcDate":"2026-04-30","resultsFirstPostDateStruct":{"date":"2026-05-22","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-05-26","lastUpdatePostDateStruct":{"date":"2026-06-17","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"VA Office of Research and Development","class":"FED"},"collaborators":[{"name":"Middlebury College","class":"UNKNOWN"},{"name":"Massachusetts General Hospital","class":"OTHER"},{"name":"Ralph H. Johnson VA Medical Center","class":"FED"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"This is a research study to examine the effectiveness of a brief screening method that may predict which people with posttraumatic stress disorder (PTSD) or depression are most likely to show a positive response to selective serotonin reuptake inhibitor (SSRI) medications. Participants will be recruited over approximately 5.25 years, until at least 94 participants complete the 17 week study.","detailedDescription":"Selective serotonin reuptake inhibitors (SSRIs) are prescribed to approximately 60% of Veterans with PTSD treated within the Veterans Health Administration (VHA). However, many patients are not responsive to SSRIs. Currently, there is no way to determine whether a particular patient will benefit from an SSRI; treatment is primarily accomplished through 'trial and error' over several weeks or months. The overarching goal of this study is to investigate the pre-treatment usefulness of a simple electrophysiological test for predicting the likelihood of a favorable response to an SSRI. This study will investigate whether a brief pre-treatment auditory event-related potentials procedure \\[referred to going forward as \"Loudness Dependence of Auditory Evoked Potentials\" (LDAEP)\\] offers a means for predicting treatment response to an SSRI for men and women diagnosed with PTSD or depression.\n\nThis study has four aims: 1) To determine the strength of the relationship between LDAEP and clinical response to SSRI treatment. 2) To determine LDAEP cut-off values that would enable clinicians to make individualized SSRI treatment recommendations. 3) To assess the usefulness of change in LDAEP as an objective measure of SSRI response. 4) Exploratory: To determine whether the relationship between LDAEP and clinical response to sertraline differs between men and women.\n\nMeans to Protect Subjects' Identities:\n\nTo ensure confidentiality, questionnaire and interview data will be stored in locked filing cabinets within locked offices. Each participant will have his or her own participant number and these numbers will be the only means by which participant information can be identified. Electronic data will be stored on a secure private, password-protected drive that can only be accessed by members of the study team and labeled only with the participant number. One list of names and participant numbers will be kept on a private, password-protected computer account on a separate drive from the de-identified data and accessible only to the study team.\n\nADMINISTRATION OF DRUGS IN RESEARCH NOT FUNDED BY NIH Description Of Identification Of Drug: SERTRALINE. Because the goal of this study is to identify pre-treatment predictors of SSRI response that ultimately could be used in routine clinical care, the investigators designed the study with ecological validity in mind. Specifically, the investigators chose sertraline as the study medication because it is: a) the most commonly prescribed SSRI in the US, b) one of only two FDA-approved drugs for treating PTSD, and c) one of the two most effective SSRIs for major depression, a common comorbidity with PTSD. Dosing will follow clinical practice guidelines, i.e., doses will be chosen based on clinical response and tolerability.\n\nDescription Of Administration Of Drug: The investigators are using an approach , which represents enhanced clinical care in that participants discuss medication levels, side effects, and symptoms with a psychiatrist every two weeks. Study medication and placebo will be stored and distributed by VA Boston Pharmacy service."},"conditionsModule":{"conditions":["Posttraumatic Stress Disorder","Major Depressive Disorder"],"keywords":["Treatment","Posttraumatic Stress Disorder (PTSD)","selective serotonin re-uptake inhibitor (SSRI)","loudness dependence of auditory evoked potentials","Electrophysiology","Depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","interventionModelDescription":"All eligible participants will first undergo a 2 week placebo lead in. Following this 2 week period, placebo responders will remain on placebo. All other participants will begin a 12 week sertraline trial.","primaryPurpose":"SCREENING","maskingInfo":{"masking":"DOUBLE","maskingDescription":"Participants will be unaware of whether or not they are on placebo or sertraline at any given moment and the placebo and sertraline capsules look identical. The outcomes assessor is unaware of the study design, study hypotheses, and whether a participant is on placebo or sertraline.","whoMasked":["PARTICIPANT","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":19,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo only arm","type":"PLACEBO_COMPARATOR","description":"For individuals who are placebo responders during the 2 week placebo lead in phase, they will remain on placebo for the duration of the study (i.e., the 12 weeks where the placebo non-responders are taking sertraline).","interventionNames":["Diagnostic Test: LDAEP","Drug: Placebo"]},{"label":"Sertraline arm","type":"ACTIVE_COMPARATOR","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.","interventionNames":["Diagnostic Test: LDAEP","Drug: Placebo","Drug: sertraline"]}],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"LDAEP","description":"This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P2 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P2 scores.","armGroupLabels":["Placebo only arm","Sertraline arm"]},{"type":"DRUG","name":"Placebo","description":"placebo pills of the same size, color and taste as the active drug will be administered","armGroupLabels":["Placebo only arm","Sertraline arm"]},{"type":"DRUG","name":"sertraline","description":"Sertraline is an FDA approved SSRI for treatment of PTSD.","armGroupLabels":["Sertraline arm"],"otherNames":["zoloft"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site) and Controlling for Baseline CAPS Score","description":"The CAPS-5 is the \"gold standard\" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.","timeFrame":"CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score"},{"measure":"Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site) and Controlling for Baseline CAPS Score","description":"The CAPS-5 is the \"gold standard\" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.","timeFrame":"CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score"},{"measure":"Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site) and Controlling for Baseline CAPS Score","description":"The CAPS-5 is the \"gold standard\" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.","timeFrame":"CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score"},{"measure":"Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site) and Controlling for Baseline CAPS Score","description":"The CAPS-5 is the \"gold standard\" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.","timeFrame":"CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score"},{"measure":"Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site) and Controlling for Baseline CAPS Score","description":"The CAPS-5 is the \"gold standard\" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.","timeFrame":"CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score"}],"secondaryOutcomes":[{"measure":"Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)","description":"The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14"},{"measure":"Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)","description":"The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14"},{"measure":"Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)","description":"The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14"},{"measure":"Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)","description":"The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14"},{"measure":"Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)","description":"The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14"},{"measure":"PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site)","description":"The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = \"not at all\" to 4 = \"extremely\") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14"},{"measure":"PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)","description":"The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = \"not at all\" to 4 = \"extremely\") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14"},{"measure":"PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)","description":"The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = \"not at all\" to 4 = \"extremely\") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14"},{"measure":"PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)","description":"The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = \"not at all\" to 4 = \"extremely\") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14"},{"measure":"PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)","description":"The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = \"not at all\" to 4 = \"extremely\") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14"},{"measure":"PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)","description":"The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = \"not at all\" to 4 = \"extremely\") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. has a history of trauma exposure as defined by criterion A of PTSD in the DSM-5\n2. meets diagnostic criteria for PTSD, subthreshold PTSD, or MDD as defined by DSM-5\n3. study psychiatrist's judgment that SSRIs are an acceptable treatment option for the participant's presenting concerns, and\n4. interest in starting a trial of an SSRI\n\nExclusion Criteria:\n\n* current or past history of bipolar I disorder, schizophrenic or other psychotic disorders\n* current organic brain disorder including severe traumatic brain injury, factitious disorder, or malingering\n* pregnancy\n* major neurological problems\n* current moderate or severe substance use disorder\n* active risk to self or others\n* evidence of clinically significant hepatic or renal disease or any other acute or unstable medical condition that might interfere with safe conduct of the study\n* intolerance or hypersensitivity to sertraline\n* failed past trial of sertraline (confirmed by medical record review)\n* use of drugs that directly affect the serotonin system (e.g., SNRIs, antipsychotics) within 3 months of the study\n* use of an SSRI within 3 months of the study. Use of other psychotropic medications must have been stable for 3 months prior to enrollment and remain stable throughout participation\n* hearing impairment for 780 Hz tones\n* current enrollment in trauma-focused psychotherapy\n* for those participants who currently have a non-VA or VA psychiatrist or primary care provider who is willing to prescribe medications, they must be willing to sign a release of information (ROI) for study staff to communicate with their providers and the provider believes that including the participant in the study is potentially appropriate.\n\n  * As discussed above, the investigators will inform the participant that the investigators will share the following information with their current relevant care provider:\n\n    * information about the design of the study, inclusion and exclusion criteria, the participant's psychiatric and medical diagnoses as well as illness severity, as assessed in the screening evaluation, and any history of safety issues such as risk to self or others.\n    * If the participant doesn't sign a release of release of information (ROI) to contact the provider, the participant will not be entered into the active study.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Suzanne Pineles, PhD","affiliation":"VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA","city":"Boston","state":"Massachusetts","zip":"02130-4817","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"Ralph H. Johnson VA Medical Center, Charleston, SC","city":"Charleston","state":"South Carolina","zip":"29401-5703","country":"United States","geoPoint":{"lat":32.77632,"lon":-79.93275}}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"A de-identified, anonymized dataset will be created and shared after study completion.","infoTypes":["STUDY_PROTOCOL","ICF"],"timeFrame":"Data will be available within a year of submission of the final report."}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"There was no preassignment to group. All participants first completed a two week placebo lead-in phase.\n\nAfter the placebo lead-in phase, participants who made meaningful symptomatic reduction on the placebo (operationalized as more than 50% improvement on the PCL and QIDS-SR) during the placebo lead in phase remained on placebo for the duration of the trial. All other participants began the sertraline phase.","groups":[{"id":"FG000","title":"Lead- in Phase","description":"All participants were administered placebo pills of the same size, color and taste as the active drug for a two week period."},{"id":"FG001","title":"Placebo Only Arm","description":"For individuals who are placebo responders during the 2 week placebo lead in phase, they will remain on placebo for the duration of the study (i.e., the 12 weeks where the placebo non-responders are taking sertraline).\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P2 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P2 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered"},{"id":"FG002","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P2 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P2 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"periods":[{"title":"Lead-in Phase","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Treatment Phase","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"16"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"12"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All study participants who passed the screening visit, started with the placebo lead-in phase (n=19) before continuing in the placebo only arm or sertraline arm.","groups":[{"id":"BG000","title":"Lead-in Phase","description":"All participants were administered placebo pills of the same size, color and taste as the active drug for a two week period."},{"id":"BG001","title":"Placebo Only Arm","description":"For individuals who are placebo responders during the 2 week placebo lead in phase, they will remain on placebo for the duration of the study (i.e., the 12 weeks where the placebo non-responders are taking sertraline).\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P2 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P2 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered"},{"id":"BG002","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P2 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P2 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"19"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"52.1","spread":"14.5"},{"groupId":"BG003","value":"52.1","spread":"14.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG003","value":"10"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG003","value":"9"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG003","value":"1"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG003","value":"7"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG003","value":"9"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG003","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG003","value":"1"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG003","value":"5"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG003","value":"13"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG003","value":"1"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"title":"Boston site","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG003","value":"18"}]},{"title":"Charleston site","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG003","value":"1"}]}]}]},{"title":"Self-reported depression symptom severity","description":"Depression symptom severity measured with Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR). The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12.4","spread":"5.01"},{"groupId":"BG003","value":"12.4","spread":"5.01"}]}]}]},{"title":"Self-reported PTSD symptom severity","description":"Self-reported PTSD symptom severity measured with the PTSD Checklist for DSM-5 (PCL-5). The total range of the CAPS-5 is 0-80, where higher scores indicate greater PTSD severity.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"38.1","spread":"17.8"},{"groupId":"BG003","value":"38.1","spread":"17.8"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site) and Controlling for Baseline CAPS Score","description":"The CAPS-5 is the \"gold standard\" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, we reduced the number of CAPS assessments to only screening and week 14. Thus, we had a very limited sample of participants who completed the 14 week study.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.8","spread":"9.95"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"This analysis will test pretreatment LDAEP slope (calculated with P200 at the PZ site) as a predictor of PTSD severity, controlling for pretreatment PTSD severity.","nonInferiorityType":"SUPERIORITY","pValue":".08","statisticalMethod":"Regression, Linear","paramType":"Slope","paramValue":"3.13","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.53","estimateComment":"Unstandardized Beta was used for the estimation parameter.","otherAnalysisDescription":"Given the sample size of 10, statistical analyses should be interpreted with caution."}]},{"type":"SECONDARY","title":"Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)","description":"The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal QIDS-SR data for inclusion in these analyses.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"}]}],"classes":[{"title":"Week 0 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"11.50","spread":"4.83"}]}]},{"title":"Week 2 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.75","spread":"4.27"}]}]},{"title":"Week 4 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.5","spread":"4.40"}]}]},{"title":"Week 6 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.15","spread":"5.00"}]}]},{"title":"Week 8 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.89","spread":"3.41"}]}]},{"title":"Week 10 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.22","spread":"4.55"}]}]},{"title":"Week 12 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.43","spread":"4.16"}]}]},{"title":"Week 14 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"8.56","spread":"3.78"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"Linear mixed-effects growth models were used to examine the longitudinal trajectory of QIDS-SR depression symptom severity over time from pre-treatment through the 14-week medication trial and the moderating effect of pre-treatment LDAEP using P200 at the FZ site. Each model included time (week), LDAEP, and the time X LDAEP interaction. The time X LDAEP interaction is reported.","nonInferiorityType":"SUPERIORITY","pValue":".87","statisticalMethod":"Mixed Models Analysis","paramType":"Slope","paramValue":".0006","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":".87","estimateComment":"Beta is reported as the estimation parameter."}]},{"type":"SECONDARY","title":"Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)","description":"The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. 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Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"}]}],"classes":[{"title":"Week 0 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"11.5","spread":"4.83"}]}]},{"title":"Week 2 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.75","spread":"2.67"}]}]},{"title":"Week 4 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.5","spread":"4.40"}]}]},{"title":"Week 6 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.15","spread":"5.00"}]}]},{"title":"Week 8 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.89","spread":"3.41"}]}]},{"title":"Week 10 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.22","spread":"4.55"}]}]},{"title":"Week 12 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.43","spread":"4.16"}]}]},{"title":"Week 14 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"8.56","spread":"3.78"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"Linear mixed-effects growth models were used to examine the longitudinal trajectory of QIDS-SR depression symptom severity over time from pre-treatment through the 14-week medication trial and the moderating effect of pre-treatment LDAEP using P200 at the CZ site. 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Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"}]}],"classes":[{"title":"Week 0 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"11.5","spread":"4.83"}]}]},{"title":"Week 2 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.75","spread":"4.27"}]}]},{"title":"Week 4 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.50","spread":"4.40"}]}]},{"title":"Week 6 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.15","spread":"5.00"}]}]},{"title":"Week 8 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.89","spread":"3.41"}]}]},{"title":"Week 10 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.22","spread":"4.55"}]}]},{"title":"Week 12 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.43","spread":"4.16"}]}]},{"title":"Week 14 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"8.56","spread":"3.78"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"Linear mixed-effects growth models were used to examine the longitudinal trajectory of QIDS-SR depression symptom severity over time from pre-treatment through the 14-week medication trial and the moderating effect of pre-treatment LDAEP using P200 at the PZ site. Each model included time (week), LDAEP, and the time X LDAEP interaction. The time X LDAEP interaction is reported.","nonInferiorityType":"SUPERIORITY","pValue":".09","statisticalMethod":"Mixed Models Analysis","paramType":"Slope","paramValue":".08","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":".05","estimateComment":"Beta is reported for the estimation parameter."}]},{"type":"PRIMARY","title":"Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site) and Controlling for Baseline CAPS Score","description":"The CAPS-5 is the \"gold standard\" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, we reduced the number of CAPS assessments to only screening and week 14. Thus, we had a very limited sample of participants who completed the 14 week study.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.8","spread":"9.95"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"This analysis will test pretreatment LDAEP slope (calculated with P200 at the CZ site) as a predictor of PTSD severity, controlling for pretreatment PTSD severity.","nonInferiorityType":"SUPERIORITY","pValue":".01","statisticalMethod":"Regression, Linear","paramType":"Slope","paramValue":"3.59","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.02","estimateComment":"Unstandardized Beta was used for the estimation parameter","otherAnalysisDescription":"Given the sample size of 10, statistical analyses should be interpreted with caution."}]},{"type":"PRIMARY","title":"Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site) and Controlling for Baseline CAPS Score","description":"The CAPS-5 is the \"gold standard\" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, we reduced the number of CAPS assessments to only screening and week 14. Thus, we had a very limited sample of participants who completed the 14 week study.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.8","spread":"25.7"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"This analysis will test pretreatment LDAEP slope (calculated with P200 at the FZ site) as a predictor of PTSD severity, controlling for pretreatment PTSD severity.","nonInferiorityType":"SUPERIORITY","pValue":".24","statisticalMethod":"Regression, Linear","paramType":"Slope","paramValue":"2.24","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.73","estimateComment":"Unstandardized Beta was used for the estimation parameter.","otherAnalysisDescription":"Given the sample size of 10, statistical analyses should be interpreted with caution."}]},{"type":"PRIMARY","title":"Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site) and Controlling for Baseline CAPS Score","description":"The CAPS-5 is the \"gold standard\" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, we reduced the number of CAPS assessments to only screening and week 14. Thus, we had a very limited sample of participants who completed the 14 week study.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.8","spread":"9.95"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"This analysis will test pretreatment LDAEP slope (calculated with N100 at the PZ site) as a predictor of PTSD severity, controlling for pretreatment PTSD severity.","nonInferiorityType":"SUPERIORITY","pValue":".997","statisticalMethod":"Regression, Linear","paramType":"Slope","paramValue":"-.01","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"-.001","estimateComment":"Unstandardized Beta was used for the estimation parameter.","otherAnalysisDescription":"Given the sample size of 10, statistical analyses should be interpreted with caution."}]},{"type":"PRIMARY","title":"Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site) and Controlling for Baseline CAPS Score","description":"The CAPS-5 is the \"gold standard\" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, we reduced the number of CAPS assessments to only screening and week 14. Thus, we had a very limited sample of participants who completed the 14 week study.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.8","spread":"9.95"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"This analysis will test pretreatment LDAEP slope (calculated with N100 at the CZ site) as a predictor of PTSD severity, controlling for pretreatment PTSD severity.","nonInferiorityType":"SUPERIORITY","pValue":".95","statisticalMethod":"Regression, Linear","paramType":"Slope","paramValue":".18","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.64","estimateComment":"Unstandardized Beta was used for the estimation parameter.","otherAnalysisDescription":"Given the sample size of 10, statistical analyses should be interpreted with caution."}]},{"type":"PRIMARY","title":"Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site) and Controlling for Baseline CAPS Score","description":"The CAPS-5 is the \"gold standard\" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, we reduced the number of CAPS assessments to only screening and week 14. Thus, we had a very limited sample of participants who completed the 14 week study.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.8","spread":"9.95"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"This analysis will test pretreatment LDAEP slope (calculated with N100 at the FZ site) as a predictor of PTSD severity, controlling for pretreatment PTSD severity.","nonInferiorityType":"SUPERIORITY","pValue":".43","statisticalMethod":"Regression, Linear","paramType":"Slope","paramValue":"-1.56","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"-2.1","estimateComment":"Unstandardized Beta was used for the estimation parameter.","otherAnalysisDescription":"Given the sample size of 10, statistical analyses should be interpreted with caution."}]},{"type":"SECONDARY","title":"Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)","description":"The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal QIDS-SR data for inclusion in these analyses.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"}]}],"classes":[{"title":"Week 0 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"11.5","spread":"4.83"}]}]},{"title":"Week 2 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.75","spread":"4.27"}]}]},{"title":"Week 4 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.5","spread":"4.40"}]}]},{"title":"Week 6 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.15","spread":"5.00"}]}]},{"title":"Week 8 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.89","spread":"3.41"}]}]},{"title":"Week 10 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.22","spread":"4.55"}]}]},{"title":"Week 12 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.43","spread":"4.16"}]}]},{"title":"Week 14 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"8.56","spread":"3.78"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"Linear mixed-effects growth models were used to examine the longitudinal trajectory of QIDS-SR depression symptom severity over time from pre-treatment through the 14-week medication trial and the moderating effect of pre-treatment LDAEP using N100 at the FZ site. Each model included time (week), LDAEP, and the time X LDAEP interaction. The time X LDAEP interaction is reported.","nonInferiorityType":"SUPERIORITY","pValue":".05","statisticalMethod":"Mixed Models Analysis","paramType":"Slope","paramValue":".08","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":".05","estimateComment":"Beta is reported as the estimation parameter."}]},{"type":"SECONDARY","title":"Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)","description":"The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal QIDS-SR data for inclusion in these analyses.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"}]}],"classes":[{"title":"Week 0 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"11.5","spread":"4.83"}]}]},{"title":"Week 2 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.75","spread":"4.27"}]}]},{"title":"Week 4 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.5","spread":"4.40"}]}]},{"title":"Week 6 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.15","spread":"5.0"}]}]},{"title":"Week 8 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.89","spread":"3.41"}]}]},{"title":"Week 10 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.22","spread":"4.55"}]}]},{"title":"Week 12 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.43","spread":"4.16"}]}]},{"title":"Week 14 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"8.56","spread":"3.78"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"Linear mixed-effects growth models were used to examine the longitudinal trajectory of QIDS-SR depression symptom severity over time from pre-treatment through the 14-week medication trial and the moderating effect of pre-treatment LDAEP using N100 at the CZ site. Each model included time (week), LDAEP, and the time X LDAEP interaction. The time X LDAEP interaction is reported.","nonInferiorityType":"SUPERIORITY","pValue":".05","statisticalMethod":"Mixed Models Analysis","paramType":"Slope","paramValue":".09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":".04","estimateComment":"Beta is reported as the estimation parameter."}]},{"type":"SECONDARY","title":"Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)","description":"The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal QIDS-SR data for inclusion in these analyses.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"}]}],"classes":[{"title":"Week 0 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"11.5","spread":"4.83"}]}]},{"title":"Week 2 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.75","spread":"4.27"}]}]},{"title":"Week 4 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.5","spread":"4.40"}]}]},{"title":"Week 6 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"10.15","spread":"5.00"}]}]},{"title":"Week 8 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.89","spread":"3.41"}]}]},{"title":"Week 10 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.22","spread":"4.55"}]}]},{"title":"Week 12 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"9.43","spread":"4.16"}]}]},{"title":"Week 14 QIDS-SR","categories":[{"measurements":[{"groupId":"OG000","value":"8.56","spread":"3.78"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"Linear mixed-effects growth models were used to examine the longitudinal trajectory of QIDS-SR depression symptom severity over time from pre-treatment through the 14-week medication trial and the moderating effect of pre-treatment LDAEP using N100 at the PZ site. Each model included time (week), LDAEP, and the time X LDAEP interaction. The time X LDAEP interaction is reported.","nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"Slope","paramValue":".25","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":".06","estimateComment":"Beta is reported as the estimation parameter."}]},{"type":"SECONDARY","title":"PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site)","description":"The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = \"not at all\" to 4 = \"extremely\") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal PCL data for inclusion in these analyses.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"}]}],"classes":[{"title":"Week 0 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"31.39","spread":"19.56"}]}]},{"title":"Week 2 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"29.19","spread":"17.22"}]}]},{"title":"Week 4 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"26.30","spread":"16.69"}]}]},{"title":"Week 6 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"25.93","spread":"16.79"}]}]},{"title":"Week 8 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"17.89","spread":"14.40"}]}]},{"title":"Week 10 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"20.22","spread":"16.04"}]}]},{"title":"Week 12 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"16.71","spread":"10.36"}]}]},{"title":"Week 14 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"17.33","spread":"11.57"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"Linear mixed-effects growth models were used to examine the longitudinal trajectory of PCL PTSD symptom severity over time from pre-treatment through the 14-week medication trial and the moderating effect of pre-treatment LDAEP using P200 at the FZ site. Each model included time (week), LDAEP, and the time X LDAEP interaction. The time X LDAEP interaction is reported.","nonInferiorityType":"SUPERIORITY","pValue":".97","statisticalMethod":"Mixed Models Analysis","paramType":"Slope","paramValue":"-.004","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":".10","estimateComment":"Beta is reported as the estimation parameter."}]},{"type":"SECONDARY","title":"PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)","description":"The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = \"not at all\" to 4 = \"extremely\") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal PCL data for inclusion in these analyses.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"}]}],"classes":[{"title":"Week 0 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"31.39","spread":"19.56"}]}]},{"title":"Week 2 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"29.19","spread":"17.22"}]}]},{"title":"Week 4 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"26.30","spread":"16.69"}]}]},{"title":"Week 6 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"25.93","spread":"16.79"}]}]},{"title":"Week 8 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"17.89","spread":"14.40"}]}]},{"title":"Week 10 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"20.22","spread":"16.04"}]}]},{"title":"Week 12 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"16.71","spread":"10.36"}]}]},{"title":"Week 14 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"17.33","spread":"11.57"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"Linear mixed-effects growth models were used to examine the longitudinal trajectory of PCL PTSD symptom severity over time from pre-treatment through the 14-week medication trial and the moderating effect of pre-treatment LDAEP using P200 at the CZ site. Each model included time (week), LDAEP, and the time X LDAEP interaction. The time X LDAEP interaction is reported.","nonInferiorityType":"SUPERIORITY","pValue":".83","statisticalMethod":"Mixed Models Analysis","paramType":"Slope","paramValue":".02","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":".11","estimateComment":"Beta is reported as the estimation parameter."}]},{"type":"SECONDARY","title":"PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)","description":"The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = \"not at all\" to 4 = \"extremely\") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal PCL data for inclusion in these analyses.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"}]}],"classes":[{"title":"Week 0 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"31.39","spread":"19.56"}]}]},{"title":"Week 2 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"29.19","spread":"17.22"}]}]},{"title":"Week 4 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"26.30","spread":"16.69"}]}]},{"title":"Week 6 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"25.93","spread":"16.79"}]}]},{"title":"Week 8 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"17.89","spread":"14.40"}]}]},{"title":"Week 10 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"20.22","spread":"16.04"}]}]},{"title":"Week 12 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"16.71","spread":"10.36"}]}]},{"title":"Week 14 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"17.33","spread":"11.57"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"Linear mixed-effects growth models were used to examine the longitudinal trajectory of PCL PTSD symptom severity over time from pre-treatment through the 14-week medication trial and the moderating effect of pre-treatment LDAEP using P200 at the PZ site. Each model included time (week), LDAEP, and the time X LDAEP interaction. The time X LDAEP interaction is reported.","nonInferiorityType":"SUPERIORITY","pValue":".44","statisticalMethod":"Mixed Models Analysis","paramType":"Slope","paramValue":".10","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":".13","estimateComment":"Beta is reported as the estimation parameter."}]},{"type":"SECONDARY","title":"PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)","description":"The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = \"not at all\" to 4 = \"extremely\") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal PCL data for inclusion in these analyses.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"}]}],"classes":[{"title":"Week 0 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"31.39","spread":"19.56"}]}]},{"title":"Week 2 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"29.19","spread":"17.22"}]}]},{"title":"Week 4 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"26.30","spread":"16.69"}]}]},{"title":"Week 6 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"25.93","spread":"16.79"}]}]},{"title":"Week 8 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"17.89","spread":"14.40"}]}]},{"title":"Week 10 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"20.22","spread":"16.04"}]}]},{"title":"Week 12 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"16.71","spread":"10.36"}]}]},{"title":"Week 14 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"17.33","spread":"11.57"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"Linear mixed-effects growth models were used to examine the longitudinal trajectory of PCL PTSD symptom severity over time from pre-treatment through the 14-week medication trial and the moderating effect of pre-treatment LDAEP using N100 at the FZ site. Each model included time (week), LDAEP, and the time X LDAEP interaction. The time X LDAEP interaction is reported.","nonInferiorityType":"SUPERIORITY","pValue":".90","statisticalMethod":"Mixed Models Analysis","paramType":"Slope","paramValue":"-.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":".11","estimateComment":"Beta is reported as the estimation parameter."}]},{"type":"SECONDARY","title":"PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)","description":"The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = \"not at all\" to 4 = \"extremely\") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal PCL data for inclusion in these analyses.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"}]}],"classes":[{"title":"Week 0 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"31.39","spread":"19.56"}]}]},{"title":"Week 2 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"29.19","spread":"17.22"}]}]},{"title":"Week 4 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"26.30","spread":"16.69"}]}]},{"title":"Week 6 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"25.93","spread":"16.79"}]}]},{"title":"Week 8 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"17.89","spread":"14.40"}]}]},{"title":"Week 10 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"20.22","spread":"16.04"}]}]},{"title":"Week 12 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"16.71","spread":"10.36"}]}]},{"title":"Week 14 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"17.33","spread":"11.57"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"Linear mixed-effects growth models were used to examine the longitudinal trajectory of PCL PTSD symptom severity over time from pre-treatment through the 14-week medication trial and the moderating effect of pre-treatment LDAEP using N100 at the CZ site. Each model included time (week), LDAEP, and the time X LDAEP interaction. The time X LDAEP interaction is reported.","nonInferiorityType":"SUPERIORITY","pValue":".63","statisticalMethod":"Mixed Models Analysis","paramType":"Slope","paramValue":"-.06","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":".12","estimateComment":"Beta is reported as the estimation parameter."}]},{"type":"SECONDARY","title":"PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)","description":"The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = \"not at all\" to 4 = \"extremely\") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.","populationDescription":"Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal PCL data for inclusion in these analyses.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14","groups":[{"id":"OG000","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"}]}],"classes":[{"title":"Week 0 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"31.39","spread":"19.56"}]}]},{"title":"Week 2 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"29.19","spread":"17.22"}]}]},{"title":"Week 4 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"26.30","spread":"16.69"}]}]},{"title":"Week 6 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"25.93","spread":"16.79"}]}]},{"title":"Week 8 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"17.89","spread":"14.40"}]}]},{"title":"Week 10 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"20.22","spread":"16.04"}]}]},{"title":"Week 12 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"16.71","spread":"10.36"}]}]},{"title":"Week 14 PCL-5","categories":[{"measurements":[{"groupId":"OG000","value":"17.33","spread":"11.57"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"Linear mixed-effects growth models were used to examine the longitudinal trajectory of PCL PTSD symptom severity over time from pre-treatment through the 14-week medication trial and the moderating effect of pre-treatment LDAEP using N100 at the PZ site. Each model included time (week), LDAEP, and the time X LDAEP interaction. The time X LDAEP interaction is reported.","nonInferiorityType":"SUPERIORITY","pValue":".15","statisticalMethod":"Mixed Models Analysis","paramType":"Slope","paramValue":".26","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":".18","estimateComment":"Beta is reported as the estimation parameter."}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"from enrollment until end of follow-up, up to 17 weeks.","description":"There were no participants in the placebo only arm.","eventGroups":[{"id":"EG000","title":"Lead-in Phase","description":"All participants were administered placebo pills of the same size, color and taste as the active drug for a two week period.","deathsNumAffected":0,"deathsNumAtRisk":19,"seriousNumAffected":0,"seriousNumAtRisk":19,"otherNumAffected":5,"otherNumAtRisk":19},{"id":"EG001","title":"Placebo Only Arm","description":"For individuals who are placebo responders during the 2 week placebo lead in phase, they will remain on placebo for the duration of the study (i.e., the 12 weeks where the placebo non-responders are taking sertraline).","deathsNumAffected":0,"deathsNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"otherNumAffected":0,"otherNumAtRisk":0},{"id":"EG002","title":"Sertraline Arm","description":"After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.\n\nLDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.\n\nPlacebo: placebo pills of the same size, color and taste as the active drug will be administered\n\nsertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.","deathsNumAffected":0,"deathsNumAtRisk":16,"seriousNumAffected":0,"seriousNumAtRisk":16,"otherNumAffected":9,"otherNumAtRisk":16}],"otherEvents":[{"term":"environmental allergies","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":16}]},{"term":"headaches","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":16}]},{"term":"abnormal EKG","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"deemed not study related","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":16}]},{"term":"increased depression symptoms","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":16}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"We fell far short of our recruitment goals, thus the sample size was greatly underpowered."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Suzanne Pineels","organization":"VABoston Healthcare System","email":"suzanne.pineles@va.gov","phone":"617-435-8742"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2025-01-14","uploadDate":"2026-03-19T09:45","filename":"Prot_SAP_001.pdf","size":659495},{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form","date":"2024-06-26","uploadDate":"2026-02-05T17:25","filename":"ICF_000.pdf","size":3390053}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2026-04-14","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D013313","term":"Stress Disorders, Post-Traumatic"},{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D040921","term":"Stress Disorders, Traumatic"},{"id":"D000068099","term":"Trauma and Stressor Related Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D020280","term":"Sertraline"}],"ancestors":[{"id":"D015057","term":"1-Naphthylamine"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009281","term":"Naphthalenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D011083","term":"Polycyclic Compounds"}]}},"hasResults":true}