{"protocolSection":{"identificationModule":{"nctId":"NCT00292370","orgStudyIdInfo":{"id":"CLIN-006-04F"},"organization":{"fullName":"VA Office of Research and Development","class":"FED"},"briefTitle":"Quetiapine Augmentation for Treatment-resistant PTSD","officialTitle":"A Placebo-controlled Trial of Adjunctive Quetiapine for Refractory PTSD"},"statusModule":{"statusVerifiedDate":"2019-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-01"},"primaryCompletionDateStruct":{"date":"2008-12","type":"ACTUAL"},"completionDateStruct":{"date":"2009-05","type":"ACTUAL"},"studyFirstSubmitDate":"2006-02-13","studyFirstSubmitQcDate":"2006-02-13","studyFirstPostDateStruct":{"date":"2006-02-15","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-02-14","resultsFirstSubmitQcDate":"2014-06-27","resultsFirstPostDateStruct":{"date":"2014-07-01","type":"ESTIMATED"},"lastUpdateSubmitDate":"2019-09-26","lastUpdatePostDateStruct":{"date":"2019-10-16","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"VA Office of Research and Development","class":"FED"},"collaborators":[{"name":"AstraZeneca","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"The purpose of this study is to compare the response of veterans with PTSD without an optimal response to paroxetine to quetiapine augmentation versus placebo.","detailedDescription":"This is a two-site study designed to evaluate the efficacy and safety of quetiapine augmentation of paroxetine treatment in veterans with PTSD who have failed to respond to paroxetine treatment.\n\nIn Phase I, eligible patients will take open-label paroxetine (up to 60 mg daily) for 8 weeks. Patients who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for the second phase. In Phase II, patients will continue taking open-label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) or placebo for 8 weeks in a double-blind fashion."},"conditionsModule":{"conditions":["Combat Disorders","Stress Disorders, Post-Traumatic"],"keywords":["Atypical Antipsychotics","Controlled Trial","Paroxetine","Quetiapine","Stress Disorders, Post-Traumatic","Treatment refractory","Treatment resistant"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":124,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Arm 1: Open Label (OL) Paroxetine","type":"OTHER","description":"Open-label Paroxetine In Phase I, eligible participants will take open-label (OL) Paroxetine (up to 60 mg) daily for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II.","interventionNames":["Drug: Open Label (OL) Paroxetine"]},{"label":"Arm 2 OL Paroxetine + DB Placebo","type":"PLACEBO_COMPARATOR","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.","interventionNames":["Drug: Open Label (OL) Paroxetine","Drug: Placebo"]},{"label":"Arm 3: OL Paroxetine + DB Quetiapine","type":"EXPERIMENTAL","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.","interventionNames":["Drug: Open Label (OL) Paroxetine","Drug: Quetiapine"]}],"interventions":[{"type":"DRUG","name":"Open Label (OL) Paroxetine","description":"Open-label Paroxetine","armGroupLabels":["Arm 1: Open Label (OL) Paroxetine","Arm 2 OL Paroxetine + DB Placebo","Arm 3: OL Paroxetine + DB Quetiapine"],"otherNames":["Paxil"]},{"type":"DRUG","name":"Placebo","description":"Double-blind placebo taken with OL paroxetine","armGroupLabels":["Arm 2 OL Paroxetine + DB Placebo"],"otherNames":["sugar pill"]},{"type":"DRUG","name":"Quetiapine","description":"Double-blind quetiapine taken with OL paroxetine","armGroupLabels":["Arm 3: OL Paroxetine + DB Quetiapine"],"otherNames":["Seroquel"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Clinician-Administered PTSD Scale for DSM-IV Total Score.","description":"The Clinician-Administered PTSD Scale for DSM-IV (CAPS) is described in the National Center for PTSD Instruction Manual (November 2000) as a semi-structured clinical interview designed to assess the seventeen symptoms for Post Traumatic Stress Disorder (PTSD) outlined in the DSM-IV, along with five associated features. Ratings are made on a 5 point continuum from the lowest frequency or intensity to the highest. Total CAPS score is a summed score that ranges from 0 to 136 where 0 is asymptomatic and higher scores equal more severe PTSD symptomatology. Also, a change in total CAPS score of 15 points was proposed as clinically significant change.","timeFrame":"From baseline (week 8) to endpoint (week 16 or termination)"}],"secondaryOutcomes":[{"measure":"Change in CGI-I","description":"Clinical Global Impressions Scale and Global Improvement Subscales (CGI-I) is a 7-point scale which was used to assess overall improvement. The scores range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse.","timeFrame":"From Baseline (week 8) to Endpoint (week 16 or termination)"},{"measure":"Change in Mean PANSS Total and Subscores From Baseline to Endpoint","description":"Positive and Negative Symptom Scale (PANSS). A 30-item clinician administered rating scale for which positive, negative and general subscales are scored from 30 to 210 with a higher scores indicating greater severity of symptoms.","timeFrame":"Baseline (week 8) to Endpoint (week 16 or termination)"},{"measure":"Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores","description":"Hamilton Rating Scale for Depression (HAMD) was used as a measure of depression. Scoring is based on a 17-item scale. Eight items are scored on a 5 point scale from 0= not present to 4= severe. The scoring is based on the first 17 items. Scores of 0-7 normal, 8-13 is mild depression, 14-18 moderate depression, 19-22 severe depression and 23 and above very severe depression; the maximum score being 52 on the 17-point scale.","timeFrame":"From Baseline (week 8) to Endpoint (week 16 or Termination)"},{"measure":"Change in Total Mean Davidson Trauma Scale (DTS)","description":"The DTS is a 17-item self-rated scale that measures the frequency and the severity of DSM-IV PTSD symptoms. Items are rated on 5-point frequency (0 = \"not at all\" to 4 = \"every day\") and severity scales (0 = \"not at all distressing\" to 4 = \"extremely distressing\"). The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). A higher score indicates higher frequency and severity. It can be used to make a preliminary determination about whether the symptoms meet DSM criteria for PTSD. Scores can also be calculated for each of the 3 PTSD symptom clusters (i.e., B, C, and D).","timeFrame":"From Baseline (week 8) to Endpoint (week 16 or Termination)"},{"measure":"Change in Mean Q-LES-Q Score From Baseline to Endpoint.","description":"Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) a self-rated 14-item questionnaire designed to assess the degree of enjoyment and satisfaction of various aspects of daily functioning. Each question is rated on a 5-point scale with scores ranging from \"1 = very poor\" to \"5 = very good\". The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. A lower score indicates worsening and a higher score indicates better quality of life.","timeFrame":"From Baseline (week 8) to Endpoint (week 16 or termination)"},{"measure":"Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint.","description":"The PSQI is one of the most frequently used self-rated sleep questionnaire. Total score ranging from 0 to 21. Higher scores are representing worse sleep quality.","timeFrame":"From Baseline (week 8) to Endpoint (week 16)"},{"measure":"Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint.","description":"The SDS is a brief 3-item questionnaire that was used as a self-report to assess the degree to which psychiatric symptoms have disrupted the patient's work, family/home responsibilities, and social life. Score ranging from 0 (no impairment) to 30 (most severe).","timeFrame":"Baseline (week 8) to Endpoint (week 16 or termination)"},{"measure":"Change in Arizona Sexual Experience Scale (ASEX)","description":"The ASEX is a brief 5-item rating scale that assesses five global aspects of sexual dysfunction. Score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.","timeFrame":"From Baseline (week 8) to Endpoint (week 16 or termination)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Veteran age 18 to 75.\n* Competent to give informed consent.\n* Meeting DSM-IV criteria for PTSD.\n* Minimal CAPS score of 50 at baseline.\n* If female of childbearing potential, patient must have a negative pregnancy test and, if sexually active, be using a medically approved contraceptive method.\n* Patients who have not taken psychiatric medications within 1 week prior to study entry (except fluoxetine \\[5 weeks\\])\n\n  * monoamine oxidase inhibitors (MAOIs \\[4 weeks\\])\n  * depot neuroleptics \\[4 weeks\\])\n  * or any investigational drug within 30 days prior to study enrollment.\n* To be eligible for Phase II\n\n  * patients must be refractory to paroxetine in Phase I, as defined by less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8\n  * must have PTSD symptoms at least moderate severity on CGI-S\n  * and must have been compliant with study medicine in Phase I, as defined by taking at least 80% of prescribed doses.\n\nExclusion Criteria:\n\n* History of sensitivity to paroxetine or quetiapine.\n* Failure to respond to a prior adequate therapeutic trial i.e. minimum of 8 weeks at maximum tolerated dose of paroxetine (up to 60 mg daily) or quetiapine (up to 800 mg daily).\n* Women who are\n\n  * breast-feeding\n  * pregnant\n  * expect to become pregnant during the course of the study\n  * or are sexually active and are not using a medically acceptable method of birth control.\n* Presence of clinically significant hepatic\n\n  * cardiovascular\n  * or other medical conditions that may prevent safe administration of paroxetine or quetiapine\n  * or any other clinically significant unstable medical conditions.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Mark B Hamner, MD BS","affiliation":"Ralph H. Johnson VA Medical Center","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Birmingham VA Medical Center","city":"Birmingham","state":"Alabama","zip":"35233","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Tuscaloosa VAMC","city":"Tuscaloosa","state":"Alabama","zip":"35404","country":"United States","geoPoint":{"lat":33.20984,"lon":-87.56917}},{"facility":"Ralph H. Johnson","city":"Charleston","state":"South Carolina","zip":"29401-5799","country":"United States","geoPoint":{"lat":32.77632,"lon":-79.93275}}]},"referencesModule":{"references":[{"pmid":"11387733","type":"BACKGROUND","citation":"Weathers FW, Keane TM, Davidson JR. Clinician-administered PTSD scale: a review of the first ten years of research. Depress Anxiety. 2001;13(3):132-56. doi: 10.1002/da.1029."}],"seeAlsoLinks":[{"label":"The National Center for PTSD is part of the US Department of Veterans Affairs","url":"https://www.ptsd.va.gov/index.asp"}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Arm 1/Open-Label (OL) Paroxetine","description":"Phase I : Open-label Paroxetine\n\nIn Phase I, eligible participants will take open-label (OL) paroxetine (up to 60 mg daily) for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II"},{"id":"FG001","title":"Arm 2/OL Paroxetine & Double-blind Placebo","description":"Phase II : Double-blind placebo\n\nIn Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind fashion."},{"id":"FG002","title":"Arm 3/OL Paroxetine & Double-blind Quetiapine","description":"Phase II : Double-blind quetiapine\n\nIn Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of quetiapine for 8 weeks in a double-blind fashion."}],"periods":[{"title":"Phase I - Open-Label Paroxetine (OLP)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"124"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"46"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Phase II: OLP + DB Quetiapine or Placebo","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"78 Completed Ph I\n\n28 Excluded Ph II:\n\n* 20 responded\n* 7 declined\n* 1 medical\n\n  50 to Arm 2 \\& 3","numSubjects":"0"},{"groupId":"FG001","comment":"25 out of 50 in Arm I PhI, eligible for Ph II","numSubjects":"25"},{"groupId":"FG002","comment":"25 out of 50 in Arm I PhI, eligible for Ph II","numSubjects":"25"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"18"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"7"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"5"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Period 1 or Phase I, 124 patients enrolled in Arm 1/Open-Label Paroxetene for 8 weeks.\n\nPeriod 2 or Phase II (intervention period), 50 patients enrolled from week 8 to week 16; 25 in Arm 2/OL paroxetene \\& DB Placebo, 25 in Arm 3/OL paroxetene \\& DB quetiapine.","groups":[{"id":"BG000","title":"Arm 1/Open-Label (OL) Paroxetine","description":"Phase I : Open-label Paroxetine\n\nIn Phase I, eligible participants will take open-label (OL) paroxetine (up to 60 mg daily) for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II"},{"id":"BG001","title":"Arm 2/OL Paroxetine & Double-blind Placebo","description":"Phase II: Double-blind placebo\n\nIn Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind fashion."},{"id":"BG002","title":"Arm 3/OL Paroxetine & Double-blind Quetiapine","description":"Phase II: Double-blind quetiapine\n\nIn Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of quetiapine in a double-blind fashion."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"174"}]}],"measures":[{"title":"Age, Customized","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"title":"Age - OL Paroxetine","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"174"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"52.32","spread":"13.23"},{"groupId":"BG001","value":"NA","spread":"NA","comment":"DB participants not randomized in OL phase I (period 1)"},{"groupId":"BG002","value":"NA","spread":"NA","comment":"DB participants not randomized in OL phase I (period 1)"},{"groupId":"BG003","value":"52.32","spread":"13.23"}]}]},{"title":"Age - Double Blind","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"174"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"NA","spread":"NA","comment":"Only randomized participants counted in phase II (period 2)."},{"groupId":"BG001","value":"57.17","spread":"8.74"},{"groupId":"BG002","value":"54.45","spread":"13.69"},{"groupId":"BG003","value":"54.76","spread":"11.48"}]}]}]},{"title":"Sex/Gender, Customized","populationDescription":"Gender for Open - Label (OL) population. Double-Blind participants not randomized in OL Phase.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Gender OL Females","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"124"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG003","value":"5"}]}]},{"title":"Gender OL Males","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"124"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"119"},{"groupId":"BG003","value":"119"}]}]}]},{"title":"Sex/Gender, Customized","populationDescription":"Gender for Double-Blind phase II","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Females Double Blind","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"50"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}]}]},{"title":"Males Double Blind","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"50"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"24"},{"groupId":"BG003","value":"48"}]}]}]},{"title":"Race/Ethnicity, Customized","populationDescription":"Race/Ethnicity for Open-Label Phase participants","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"OL Amer Indian/ Alask Native","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"124"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG003","value":"2"}]}]},{"title":"OL African American","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"124"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG003","value":"50"}]}]},{"title":"OL White","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"124"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"68"},{"groupId":"BG003","value":"68"}]}]},{"title":"OL Unknown or Not Reported","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"124"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG003","value":"4"}]}]}]},{"title":"Race/Ethnicity, Customized","populationDescription":"Race/Ethnicity for Double-Blind participants","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"DB Amer Indian/ Alaska Native","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"50"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]},{"title":"DB African American","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"50"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"25"}]}]},{"title":"DB White","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"50"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"14"},{"groupId":"BG003","value":"23"}]}]},{"title":"DB Unknown/ Not Reported","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"50"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}]}]}]},{"title":"Region of Enrollment","populationDescription":"Same region as in OL phase","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"124"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"124"},{"groupId":"BG003","value":"124"}]}]}]},{"title":"Years of Education","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"title":"Education - Open Label (OL) Population","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"174"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"13.12","spread":"2.05"},{"groupId":"BG001","value":"NA","spread":"NA","comment":"DB participants not yet randomized in OL, phase I."},{"groupId":"BG002","value":"NA","spread":"NA","comment":"DB participants not yet randomized in OL, phase I."},{"groupId":"BG003","value":"13.12","spread":"2.05"}]}]},{"title":"Education - Double Blind (DB), Phase II","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"174"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"NA","spread":"NA","comment":"Only randomized participants counted in DB, phase II."},{"groupId":"BG001","value":"13.22","spread":"2.74"},{"groupId":"BG002","value":"12.55","spread":"1.53"},{"groupId":"BG003","value":"12.89","spread":"2.24"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Clinician-Administered PTSD Scale for DSM-IV Total Score.","description":"The Clinician-Administered PTSD Scale for DSM-IV (CAPS) is described in the National Center for PTSD Instruction Manual (November 2000) as a semi-structured clinical interview designed to assess the seventeen symptoms for Post Traumatic Stress Disorder (PTSD) outlined in the DSM-IV, along with five associated features. Ratings are made on a 5 point continuum from the lowest frequency or intensity to the highest. Total CAPS score is a summed score that ranges from 0 to 136 where 0 is asymptomatic and higher scores equal more severe PTSD symptomatology. Also, a change in total CAPS score of 15 points was proposed as clinically significant change.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"From baseline (week 8) to endpoint (week 16 or termination)","groups":[{"id":"OG000","title":"Arm 2 OL Paroxetine + DB Placebo","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nPlacebo: Double-blind placebo taken with OL paroxetine"},{"id":"OG001","title":"Arm 3: OL Paroxetine + DB Quetiapine","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nQuetiapine: Double-blind quetiapine taken with OL paroxetine"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"25"}]}],"classes":[{"title":"CAPS Total Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"72.15","spread":"15.96"},{"groupId":"OG001","value":"68.78","spread":"17.01"}]}]},{"title":"CAPS Total Endpoint","categories":[{"measurements":[{"groupId":"OG000","value":"67.90","spread":"14.90"},{"groupId":"OG001","value":"51.52","spread":"19.68"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.05","statisticalMethod":"Mixed Models Analysis"}]},{"type":"SECONDARY","title":"Change in CGI-I","description":"Clinical Global Impressions Scale and Global Improvement Subscales (CGI-I) is a 7-point scale which was used to assess overall improvement. The scores range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse.","populationDescription":"Randomized participants with CGI-I score","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"From Baseline (week 8) to Endpoint (week 16 or termination)","groups":[{"id":"OG000","title":"Arm 2 OL Paroxetine + DB Placebo","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nPlacebo: Double-blind placebo taken with OL paroxetine"},{"id":"OG001","title":"Arm 3: OL Paroxetine + DB Quetiapine","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nQuetiapine: Double-blind quetiapine taken with OL paroxetine"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"25"}]}],"classes":[{"title":"Baseline CGI-I","categories":[{"measurements":[{"groupId":"OG000","value":"3.56","spread":".85"},{"groupId":"OG001","value":"3.36","spread":".88"}]}]},{"title":"Endpoint CGI-I","categories":[{"measurements":[{"groupId":"OG000","value":"2.61","spread":".79"},{"groupId":"OG001","value":"2.22","spread":"1.19"}]}]}]},{"type":"SECONDARY","title":"Change in Mean PANSS Total and Subscores From Baseline to Endpoint","description":"Positive and Negative Symptom Scale (PANSS). A 30-item clinician administered rating scale for which positive, negative and general subscales are scored from 30 to 210 with a higher scores indicating greater severity of symptoms.","populationDescription":"Randomized participants with a PANSS score","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline (week 8) to Endpoint (week 16 or termination)","groups":[{"id":"OG000","title":"Arm 2 OL Paroxetine + DB Placebo","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nPlacebo: Double-blind placebo taken with OL paroxetine"},{"id":"OG001","title":"Arm 3: OL Paroxetine + DB Quetiapine","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nQuetiapine: Double-blind quetiapine taken with OL paroxetine"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"25"}]}],"classes":[{"title":"Baseline Total PANSS","categories":[{"measurements":[{"groupId":"OG000","value":"46.63","spread":"10.13"},{"groupId":"OG001","value":"47.76","spread":"11.09"}]}]},{"title":"Endpoint Total PANSS","categories":[{"measurements":[{"groupId":"OG000","value":"43.92","spread":"6.81"},{"groupId":"OG001","value":"42.24","spread":"8.07"}]}]}]},{"type":"SECONDARY","title":"Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores","description":"Hamilton Rating Scale for Depression (HAMD) was used as a measure of depression. Scoring is based on a 17-item scale. Eight items are scored on a 5 point scale from 0= not present to 4= severe. The scoring is based on the first 17 items. Scores of 0-7 normal, 8-13 is mild depression, 14-18 moderate depression, 19-22 severe depression and 23 and above very severe depression; the maximum score being 52 on the 17-point scale.","populationDescription":"Randomized participants with a HAMD score.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"From Baseline (week 8) to Endpoint (week 16 or Termination)","groups":[{"id":"OG000","title":"Arm 2 OL Paroxetine + DB Placebo","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nPlacebo: Double-blind placebo taken with OL paroxetine"},{"id":"OG001","title":"Arm 3: OL Paroxetine + DB Quetiapine","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nQuetiapine: Double-blind quetiapine taken with OL paroxetine"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"25"}]}],"classes":[{"title":"Baseline HAMD","categories":[{"measurements":[{"groupId":"OG000","value":"14.60","spread":"5.45"},{"groupId":"OG001","value":"13.84","spread":"6.05"}]}]},{"title":"Endpoint HAMD","categories":[{"measurements":[{"groupId":"OG000","value":"12.29","spread":"6.35"},{"groupId":"OG001","value":"9.29","spread":"4.56"}]}]}]},{"type":"SECONDARY","title":"Change in Total Mean Davidson Trauma Scale (DTS)","description":"The DTS is a 17-item self-rated scale that measures the frequency and the severity of DSM-IV PTSD symptoms. Items are rated on 5-point frequency (0 = \"not at all\" to 4 = \"every day\") and severity scales (0 = \"not at all distressing\" to 4 = \"extremely distressing\"). The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). A higher score indicates higher frequency and severity. It can be used to make a preliminary determination about whether the symptoms meet DSM criteria for PTSD. Scores can also be calculated for each of the 3 PTSD symptom clusters (i.e., B, C, and D).","populationDescription":"Randomized participants with a DTS score","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"From Baseline (week 8) to Endpoint (week 16 or Termination)","groups":[{"id":"OG000","title":"Arm 2 OL Paroxetine + DB Placebo","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nPlacebo: Double-blind placebo taken with OL paroxetine"},{"id":"OG001","title":"Arm 3: OL Paroxetine + DB Quetiapine","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nQuetiapine: Double-blind quetiapine taken with OL paroxetine"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"25"}]}],"classes":[{"title":"Baseline DTS","categories":[{"measurements":[{"groupId":"OG000","value":"82.19","spread":"24.60"},{"groupId":"OG001","value":"77.25","spread":"25.94"}]}]},{"title":"Endpoint DTS","categories":[{"measurements":[{"groupId":"OG000","value":"84.06","spread":"21.92"},{"groupId":"OG001","value":"61.50","spread":"18.20"}]}]}]},{"type":"SECONDARY","title":"Change in Mean Q-LES-Q Score From Baseline to Endpoint.","description":"Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) a self-rated 14-item questionnaire designed to assess the degree of enjoyment and satisfaction of various aspects of daily functioning. Each question is rated on a 5-point scale with scores ranging from \"1 = very poor\" to \"5 = very good\". The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. A lower score indicates worsening and a higher score indicates better quality of life.","populationDescription":"Randomized participants with a Q-LES-Q score.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"From Baseline (week 8) to Endpoint (week 16 or termination)","groups":[{"id":"OG000","title":"Arm 2 OL Paroxetine + DB Placebo","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nPlacebo: Double-blind placebo taken with OL paroxetine"},{"id":"OG001","title":"Arm 3: OL Paroxetine + DB Quetiapine","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nQuetiapine: Double-blind quetiapine taken with OL paroxetine"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"25"}]}],"classes":[{"title":"Baseline Q-LES-Q","categories":[{"measurements":[{"groupId":"OG000","value":"37.85","spread":"7.78"},{"groupId":"OG001","value":"40.44","spread":"8.82"}]}]},{"title":"Endpoint Q-LES-Q","categories":[{"measurements":[{"groupId":"OG000","value":"38.22","spread":"6.62"},{"groupId":"OG001","value":"41.06","spread":"6.70"}]}]}]},{"type":"SECONDARY","title":"Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint.","description":"The PSQI is one of the most frequently used self-rated sleep questionnaire. Total score ranging from 0 to 21. Higher scores are representing worse sleep quality.","populationDescription":"Randomized participants with a PSQI score.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"From Baseline (week 8) to Endpoint (week 16)","groups":[{"id":"OG000","title":"Arm 2 OL Paroxetine + DB Placebo","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nPlacebo: Double-blind placebo taken with OL paroxetine"},{"id":"OG001","title":"Arm 3: OL Paroxetine + DB Quetiapine","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nQuetiapine: Double-blind quetiapine taken with OL paroxetine"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"25"}]}],"classes":[{"title":"Baseline PSQI","categories":[{"measurements":[{"groupId":"OG000","value":"11.60","spread":"3.93"},{"groupId":"OG001","value":"12.69","spread":"3.46"}]}]},{"title":"Endpoint PSQI","categories":[{"measurements":[{"groupId":"OG000","value":"8.70","spread":"3.15"},{"groupId":"OG001","value":"13.19","spread":"2.88"}]}]}]},{"type":"SECONDARY","title":"Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint.","description":"The SDS is a brief 3-item questionnaire that was used as a self-report to assess the degree to which psychiatric symptoms have disrupted the patient's work, family/home responsibilities, and social life. Score ranging from 0 (no impairment) to 30 (most severe).","populationDescription":"Randomized participants with an SDS score","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline (week 8) to Endpoint (week 16 or termination)","groups":[{"id":"OG000","title":"Arm 2 OL Paroxetine + DB Placebo","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nPlacebo: Double-blind placebo taken with OL paroxetine"},{"id":"OG001","title":"Arm 3: OL Paroxetine + DB Quetiapine","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nQuetiapine: Double-blind quetiapine taken with OL paroxetine"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"25"}]}],"classes":[{"title":"Baseline SDS-WS","categories":[{"measurements":[{"groupId":"OG000","value":"5.07","spread":"3.45"},{"groupId":"OG001","value":"4.44","spread":"2.95"}]}]},{"title":"Endpoint SDS-WS","categories":[{"measurements":[{"groupId":"OG000","value":"4.58","spread":"2.99"},{"groupId":"OG001","value":"4.66","spread":"2.34"}]}]},{"title":"Baseline SDS-SL","categories":[{"measurements":[{"groupId":"OG000","value":"6.67","spread":"2.44"},{"groupId":"OG001","value":"5.64","spread":"2.93"}]}]},{"title":"Endpoint SDS-SL","categories":[{"measurements":[{"groupId":"OG000","value":"5.92","spread":"2.55"},{"groupId":"OG001","value":"4.95","spread":"1.83"}]}]},{"title":"Baseline SDS-FL","categories":[{"measurements":[{"groupId":"OG000","value":"5.85","spread":"2.92"},{"groupId":"OG001","value":"4.72","spread":"2.48"}]}]},{"title":"Endpoint SDS-FL","categories":[{"measurements":[{"groupId":"OG000","value":"5.39","spread":"2.48"},{"groupId":"OG001","value":"4.61","spread":"2.27"}]}]}]},{"type":"SECONDARY","title":"Change in Arizona Sexual Experience Scale (ASEX)","description":"The ASEX is a brief 5-item rating scale that assesses five global aspects of sexual dysfunction. Score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.","populationDescription":"Randomized participants with an ASEX score.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"From Baseline (week 8) to Endpoint (week 16 or termination)","groups":[{"id":"OG000","title":"Arm 2 OL Paroxetine + DB Placebo","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nPlacebo: Double-blind placebo taken with OL paroxetine"},{"id":"OG001","title":"Arm 3: OL Paroxetine + DB Quetiapine","description":"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.\n\nOpen Label (OL) Paroxetine: Open-label Paroxetine\n\nQuetiapine: Double-blind quetiapine taken with OL paroxetine"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"25"}]}],"classes":[{"title":"Baseline ASEX","categories":[{"measurements":[{"groupId":"OG000","value":"22.00","spread":"6.68"},{"groupId":"OG001","value":"17.88","spread":"5.33"}]}]},{"title":"Endpoint ASEX","categories":[{"measurements":[{"groupId":"OG000","value":"21.93","spread":"7.45"},{"groupId":"OG001","value":"16.94","spread":"5.84"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Collected over 4 months per subject.","description":"Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.","eventGroups":[{"id":"EG000","title":"Arm 1: Open Label (OL) Paroxetine","description":"In Phase I, eligible participants will take open-label (OL) Paroxetine (up to 60 mg) daily for 8 weeks. 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