{"protocolSection":{"identificationModule":{"nctId":"NCT00560612","orgStudyIdInfo":{"id":"VA IRB# 00993"},"organization":{"fullName":"Durham VA Medical Center","class":"FED"},"briefTitle":"Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)","officialTitle":"Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)"},"statusModule":{"statusVerifiedDate":"2019-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-01"},"primaryCompletionDateStruct":{"date":"2008-07","type":"ACTUAL"},"completionDateStruct":{"date":"2008-07","type":"ACTUAL"},"studyFirstSubmitDate":"2007-11-19","studyFirstSubmitQcDate":"2007-11-19","studyFirstPostDateStruct":{"date":"2007-11-20","type":"ESTIMATED"},"resultsFirstSubmitDate":"2010-11-30","resultsFirstSubmitQcDate":"2010-12-29","resultsFirstPostDateStruct":{"date":"2011-01-25","type":"ESTIMATED"},"lastUpdateSubmitDate":"2019-05-24","lastUpdatePostDateStruct":{"date":"2019-06-18","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Durham VA Medical Center","class":"FED"}},"descriptionModule":{"briefSummary":"The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine for the treatment of subthreshold posttraumatic stress disorder (PTSD) in veterans in the early post-deployment period; and 2) To determine the potential efficacy of paroxetine in preventing the progression of anxiety symptoms to PTSD and other anxiety disorders, and improving overall veteran function.","detailedDescription":"See brief summary"},"conditionsModule":{"conditions":["Stress Disorders, Post-Traumatic"],"keywords":["PTSD","Paroxetine","Subthreshold"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"PREVENTION","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":12,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Paroxetine","type":"ACTIVE_COMPARATOR","description":"Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.","interventionNames":["Drug: Paroxetine"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Paroxetine","description":"Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.","armGroupLabels":["Paroxetine"]},{"type":"DRUG","name":"Placebo","description":"Placebo: same as paroxetine (active comparator)","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Clinician Administered PTSD Scale (CAPS) Scores","description":"Mean change scores in posttraumatic stress disorder symptoms. Raw scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).\n\nA reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms. The outcome measure is the change in scores before and after treatment. That is, the baseline and at 12 weeks difference scores.","timeFrame":"Change in Scores (12 weeks-Baseline)"}],"secondaryOutcomes":[{"measure":"Change in Short PTSD Rating Interview Scores","description":"The SPRINT contains 8 questions which are rated on a 0-4 scale (0=not at all; 4=very much). The total score is computed from summing questions #1-8 (range=0-32). The higher the total score, the worse the symptoms. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.","timeFrame":"Change in Scores (12 weeks-Baseline)"},{"measure":"Change in Connor Davidson Resilience Scale Scores","description":"This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.","timeFrame":"Change in Scores (12 Weeks-Baseline)"},{"measure":"Change in Hospital Anxiety and Depression Scale Scores","description":"The total HADS score is presented, which is regarded as a global measure of psychological distress. The total score ranges from 0-42. Each individual question is rated on a 4 point scale (0=absent to 3 =extreme presence). The higher the score, the greater level of psychological distress. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.","timeFrame":"Change in Scores (12 Weeks-Baseline)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Veterans 18-55 years of age\n2. Diagnosis of subthreshold PTSD (at least one symptom in PTSD symptom clusters B, C, and D by structured interview; with or without functional impairment exposure to war zone stressors)\n3. Written informed consent; and\n4. A negative serum pregnancy test for women of childbearing potential.\n\nExclusion Criteria:\n\n1. Lifetime history of DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition\n2. History of substance dependence within the last 3 months\n3. Significant suicide risk or serious suicide attempt within the last year\n4. Clinically significant medical condition or laboratory or EKG abnormality\n5. Women of childbearing potential who are unwilling to practice an acceptable method of contraception\n6. Subjects needing concurrent use of psychiatric medications\n7. History of hypersensitivity to paroxetine\n8. HADS depression subscale score \\> 12\n9. Failure to respond to an adequate trial of paroxetine (20 mg/day x 8 wks).","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"55 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Christine E Marx, MD, MA","affiliation":"Durham VAMC","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Durham VAMC","city":"Durham","state":"North Carolina","zip":"27705","country":"United States","geoPoint":{"lat":35.99403,"lon":-78.89862}}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Patient enrollment at the Durham VA Medical Center occurred from February 2006 until July 2008.","groups":[{"id":"FG000","title":"Paroxetine","description":"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).\n\nWeek 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).\n\nWeek 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).\n\nWeek 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).\n\nWeek 12: Final study visit (no study medication dispensed)."},{"id":"FG001","title":"Placebo","description":"Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Paroxetine","description":"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).\n\nWeek 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).\n\nWeek 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).\n\nWeek 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).\n\nWeek 12: Final study visit (no study medication dispensed)."},{"id":"BG001","title":"Placebo","description":"Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed)."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"12"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"12"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"39.3","spread":"4.73"},{"groupId":"BG001","value":"35.9","spread":"9.69"},{"groupId":"BG002","value":"37.3","spread":"7.9"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"10"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"12"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Clinician Administered PTSD Scale (CAPS) Scores","description":"Mean change scores in posttraumatic stress disorder symptoms. Raw scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).\n\nA reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms. The outcome measure is the change in scores before and after treatment. That is, the baseline and at 12 weeks difference scores.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"Change in Scores (12 weeks-Baseline)","groups":[{"id":"OG000","title":"Paroxetine","description":"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).\n\nWeek 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).\n\nWeek 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).\n\nWeek 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).\n\nWeek 12: Final study visit (no study medication dispensed)."},{"id":"OG001","title":"Placebo","description":"Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.40","spread":"7.37"},{"groupId":"OG001","value":"-5.00","spread":"6.78"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7054","statisticalMethod":"t-test, 2 sided"}]},{"type":"SECONDARY","title":"Change in Short PTSD Rating Interview Scores","description":"The SPRINT contains 8 questions which are rated on a 0-4 scale (0=not at all; 4=very much). The total score is computed from summing questions #1-8 (range=0-32). The higher the total score, the worse the symptoms. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Change in Scores (12 weeks-Baseline)","groups":[{"id":"OG000","title":"Paroxetine","description":"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).\n\nWeek 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).\n\nWeek 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).\n\nWeek 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).\n\nWeek 12: Final study visit (no study medication dispensed)."},{"id":"OG001","title":"Placebo","description":"Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.80","spread":"6.14"},{"groupId":"OG001","value":"-2.00","spread":"1.15"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.4583","statisticalMethod":"t-test, 2 sided"}]},{"type":"SECONDARY","title":"Change in Connor Davidson Resilience Scale Scores","description":"This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Change in Scores (12 Weeks-Baseline)","groups":[{"id":"OG000","title":"Paroxetine","description":"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).\n\nWeek 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).\n\nWeek 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).\n\nWeek 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).\n\nWeek 12: Final study visit (no study medication dispensed)."},{"id":"OG001","title":"Placebo","description":"Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.80","spread":"11.67"},{"groupId":"OG001","value":"-1.29","spread":"9.86"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7443","statisticalMethod":"t-test, 2 sided"}]},{"type":"SECONDARY","title":"Change in Hospital Anxiety and Depression Scale Scores","description":"The total HADS score is presented, which is regarded as a global measure of psychological distress. The total score ranges from 0-42. Each individual question is rated on a 4 point scale (0=absent to 3 =extreme presence). The higher the score, the greater level of psychological distress. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Change in Scores (12 Weeks-Baseline)","groups":[{"id":"OG000","title":"Paroxetine","description":"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).\n\nWeek 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).\n\nWeek 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).\n\nWeek 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).\n\nWeek 12: Final study visit (no study medication dispensed)."},{"id":"OG001","title":"Placebo","description":"Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.40","spread":"2.70"},{"groupId":"OG001","value":"-0.17","spread":"1.80"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.065","statisticalMethod":"t-test, 2 sided"}]}]},"adverseEventsModule":{"frequencyThreshold":"1","eventGroups":[{"id":"EG000","title":"Paroxetine","description":"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).\n\nWeek 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).\n\nWeek 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).\n\nWeek 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).\n\nWeek 12: Final study visit (no study medication dispensed).","seriousNumAffected":0,"seriousNumAtRisk":5,"otherNumAffected":5,"otherNumAtRisk":5},{"id":"EG001","title":"Placebo","description":"Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).","seriousNumAffected":0,"seriousNumAtRisk":7,"otherNumAffected":5,"otherNumAtRisk":7}],"otherEvents":[{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":5},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"Decreased Appetite","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":5},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"Decreased Interest in Sex","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":5},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":7}]},{"term":"Dermatological","organSystem":"General 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disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":5},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"Excitement/Agitation","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":5},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"Headache","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":5},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":7}]},{"term":"Hypertension","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":5},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"Impaired Sexual Performance","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":1,"numAtRisk":5},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":7}]},{"term":"Increased Appetite","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":5},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"Insomnia","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":5},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"Joint Pain/Stiffness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":5},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"Malaise","organSystem":"General 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disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":5},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":7}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Christine Marx, MD","organization":"Durham VA Medical Center","email":"marx0001@mc.duke.edu","phone":"919 286-0411","phoneExt":"7426"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D013313","term":"Stress Disorders, Post-Traumatic"}],"ancestors":[{"id":"D040921","term":"Stress Disorders, Traumatic"},{"id":"D000068099","term":"Trauma and Stressor Related Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D017374","term":"Paroxetine"}],"ancestors":[{"id":"D010880","term":"Piperidines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}