{"protocolSection":{"identificationModule":{"nctId":"NCT01111565","orgStudyIdInfo":{"id":"31-08-263"},"secondaryIdInfos":[{"id":"2010-018859-97","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Otsuka Pharmaceutical Development & Commercialization, Inc.","class":"INDUSTRY"},"briefTitle":"Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)","officialTitle":"A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2021-12","overallStatus":"TERMINATED","whyStopped":"The study was terminated early due to Sponsor decision, closure of this combination therapy program is unrelated to any safety issues, no signals of concern.","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-10-04","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2011-09-01","type":"ACTUAL"},"completionDateStruct":{"date":"2011-09-01","type":"ACTUAL"},"studyFirstSubmitDate":"2010-04-22","studyFirstSubmitQcDate":"2010-04-26","studyFirstPostDateStruct":{"date":"2010-04-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2021-11-10","resultsFirstSubmitQcDate":"2021-12-20","resultsFirstPostDateStruct":{"date":"2021-12-21","type":"ACTUAL"},"dispFirstSubmitDate":"2012-08-17","dispFirstSubmitQcDate":"2012-08-24","dispFirstPostDateStruct":{"date":"2012-08-31","type":"ESTIMATED"},"lastUpdateSubmitDate":"2021-12-20","lastUpdatePostDateStruct":{"date":"2021-12-21","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Otsuka Pharmaceutical Development & Commercialization, Inc.","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for the current MDD episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the participant's self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the participant's medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the ATRQ.","detailedDescription":"The study will be organized as follows:\n\n* Screening Phase\n* Single-blind Prospective Treatment Phase\n* Single-blind Continuation Phase (Responder)or Double-blind Randomization Phase (non-Responder)\n* 30 day Post Treatment Follow-up\n\nAssigned Interventions:\n\n* Escitalopram monotherapy\n* Aripiprazole/Escitalopram combination therapy\n* Aripiprazole monotherapy"},"conditionsModule":{"conditions":["Major Depressive Disorder (MDD)"],"keywords":["Major Depressive Disorder","MDD","Depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":137,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Phase B: Single-blind Prospective Treatment Phase","type":"EXPERIMENTAL","description":"Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the Week 1 (end of Week 1) based upon tolerability profile, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.","interventionNames":["Drug: Escitalopram"]},{"label":"Phase B+: Single-blind Phase B Responders","type":"EXPERIMENTAL","description":"Participants with response (≥50% reduction in depressive symptom severity in HAM-D17 Total Score; or a HAM-D17 Total Score of \\<14 at Week 8 or a Clinical Global Impression of Improvement (CGI-I) Score of \\<3 at the Week 6 or 8) at the end of the Phase B (Week 8) continued treatment with the single-blind escitalopram monotherapy at the dose (10 or 20 mg/day) taken during the final week of Phase B, for an additional 6 weeks (Up to Week 14), in Phase B+.","interventionNames":["Drug: Escitalopram"]},{"label":"Phase C: Aripiprazole/Escitalopram Combination","type":"EXPERIMENTAL","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.","interventionNames":["Drug: Escitalopram","Drug: Aripiprazole"]},{"label":"Phase C: Escitalopram Monotherapy","type":"EXPERIMENTAL","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.","interventionNames":["Drug: Escitalopram"]},{"label":"Phase C: Aripiprazole Monotherapy","type":"EXPERIMENTAL","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability.","interventionNames":["Drug: Aripiprazole"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"Escitalopram capsule administered orally, once daily without regard to meals.","armGroupLabels":["Phase B+: Single-blind Phase B Responders","Phase B: Single-blind Prospective Treatment Phase","Phase C: Aripiprazole/Escitalopram Combination","Phase C: Escitalopram Monotherapy"]},{"type":"DRUG","name":"Aripiprazole","description":"Aripiprazole capsule administered orally, once daily without regard to meals.","armGroupLabels":["Phase C: Aripiprazole Monotherapy","Phase C: Aripiprazole/Escitalopram Combination"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)","description":"The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. Last observation carried forward (LOCF) method was used for analyses.","timeFrame":"Week 8 to Week 14"}],"secondaryOutcomes":[{"measure":"Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at the End of Phase C","description":"CGI-I is a 7-point clinician-rated scale ranging from 1 to 7, rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. A higher score indicates greater impairment. LOCF method was used for analyses.","timeFrame":"Week 14"},{"measure":"Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)","description":"SDS is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement. LOCF method was used for analyses.","timeFrame":"Week 8 to Week 14"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Participants with a current diagnosis of a major depressive episode. The current depressive episode must be ≥8 weeks in duration\n* Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period\n* Participants with a 17-item Hamilton Depression Rating Scale (HAM-D17) Total Score ≥18 at the Baseline for the Prospective Treatment Phase\n\nExclusion Criteria:\n\n* Lack of prior treatment with an antidepressant during the current depressive episode\n* Participants who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode.\n* Participants experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode\n* Participants with epilepsy or significant history of seizure disorders\n* Participants with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder\n* Participants who have received electroconvulsive therapy (ECT) in the last 10 years","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"city":"Tucson","state":"Arizona","zip":"85710","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"city":"Chino","state":"California","zip":"91710","country":"United States","geoPoint":{"lat":34.01223,"lon":-117.68894}},{"city":"Riverside","state":"California","zip":"92506","country":"United States","geoPoint":{"lat":33.95335,"lon":-117.39616}},{"city":"Torrance","state":"California","zip":"90502","country":"United States","geoPoint":{"lat":33.83585,"lon":-118.34063}},{"city":"Hamden","state":"Connecticut","zip":"06518","country":"United States","geoPoint":{"lat":41.39593,"lon":-72.89677}},{"city":"Marietta","state":"Georgia","zip":"30060","country":"United 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the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.","timeFrame":"Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.","accessCriteria":"Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/","url":"https://clinical-trials.otsuka.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 137 participants were enrolled in Phase B (Single-blind Prospective Treatment Phase) to receive escitalopram monotherapy(10 or 20mg/day),of which 26 responders continued to Phase B+(Single-blind Phase B Responders),received escitalopram monotherapy(10 or 20mg/day).45 non-responders were randomized in 1:1:1 ratio to Phase C(Double-blind Randomization Phase),received aripiprazole/escitalopram combination therapy or escitalopram or aripiprazole monotherapy.","recruitmentDetails":"Participants took part in the study at 70 investigative sites in the United States, Canada, France, India, Malaysia, Poland, and South Africa from 4 October 2010 to 1 September 2011.","groups":[{"id":"FG000","title":"Phase B: Single-blind Prospective Treatment Phase","description":"Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the Week 1 (end of Week 1) based upon tolerability profile, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+."},{"id":"FG001","title":"Phase B+: Single-blind Phase B Responders","description":"Participants with response (≥50% reduction in depressive symptom severity in HAM-D17 Total Score; or a HAM-D17 Total Score of \\<14 at Week 8 or a Clinical Global Impression of Improvement (CGI-I) Score of \\<3 at the Week 6 or 8) at the end of the Phase B (Week 8) continued treatment with the single-blind escitalopram monotherapy at the dose (10 or 20 mg/day) taken during the final week of Phase B, for an additional 6 weeks (Up to Week 14), in Phase B+."},{"id":"FG002","title":"Phase C: Aripiprazole/Escitalopram Combination","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated."},{"id":"FG003","title":"Phase C: Escitalopram Monotherapy","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C."},{"id":"FG004","title":"Phase C: Aripiprazole Monotherapy","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability."}],"periods":[{"title":"Phase B (Weeks 0 to 8)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"137"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"71"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"66"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Sponsor Discontinued Study","reasons":[{"groupId":"FG000","numSubjects":"58"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Investigator Withdrew Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Subject Withdrew Consent","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Protocol Deviation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Lack of Efficacy as Determined by the Investigator","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]}]},{"title":"Phase B + and Phase C (Weeks 9 to 14)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"16"},{"groupId":"FG003","numSubjects":"14"},{"groupId":"FG004","numSubjects":"15"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"19"},{"groupId":"FG002","numSubjects":"11"},{"groupId":"FG003","numSubjects":"10"},{"groupId":"FG004","numSubjects":"11"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Sponsor Discontinued Study","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"3"}]},{"type":"Investigator Withdrew Subjects","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Subjects Withdrew Consent","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record.","groups":[{"id":"BG000","title":"Phase B: Single-blind Prospective Treatment Phase","description":"Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the Week 1 (end of Week 1) based upon tolerability profile, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"137"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"43.3","spread":"12.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"90"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"47"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"6"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"129"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"2"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"10"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"26"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"90"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"11"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)","description":"The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. Last observation carried forward (LOCF) method was used for analyses.","populationDescription":"Intent-to-treat (ITT) Sample included all participants in the Randomized Sample who received at least one dose of double blind trial medication and had at least one post-randomization efficacy evaluation in Phase C.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Week 8 to Week 14","groups":[{"id":"OG000","title":"Phase C: Aripiprazole/Escitalopram Combination","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated."},{"id":"OG001","title":"Phase C: Escitalopram Monotherapy","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C."},{"id":"OG002","title":"Phase C: Aripiprazole Monotherapy","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.0","spread":"2.1"},{"groupId":"OG001","value":"-3.6","spread":"2.2"},{"groupId":"OG002","value":"-3.8","spread":"2.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.079","statisticalMethod":"ANCOVA","paramType":"Treatment Difference","paramValue":"-5.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.5","ciUpperLimit":"0.7"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.085","statisticalMethod":"ANCOVA","paramType":"Treatment Difference","paramValue":"-5.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.2","ciUpperLimit":"0.7"}]},{"type":"SECONDARY","title":"Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at the End of Phase C","description":"CGI-I is a 7-point clinician-rated scale ranging from 1 to 7, rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. A higher score indicates greater impairment. LOCF method was used for analyses.","populationDescription":"ITT Sample included all participants in the Randomized Sample who received at least one dose of double blind trial medication and had at least one post-randomization efficacy evaluation in Phase C.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Week 14","groups":[{"id":"OG000","title":"Phase C: Aripiprazole/Escitalopram Combination","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated."},{"id":"OG001","title":"Phase C: Escitalopram Monotherapy","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C."},{"id":"OG002","title":"Phase C: Aripiprazole Monotherapy","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.5","spread":"0.2"},{"groupId":"OG001","value":"3.0","spread":"0.2"},{"groupId":"OG002","value":"2.9","spread":"0.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.148","statisticalMethod":"Cochran-Mantel-Haenszel","statisticalComment":"Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.","paramType":"Treatment Difference","paramValue":"-0.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.1","ciUpperLimit":"0.1"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.242","statisticalMethod":"Cochran-Mantel-Haenszel","statisticalComment":"Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.","paramType":"Treatment Difference","paramValue":"-0.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.0","ciUpperLimit":"0.3"}]},{"type":"SECONDARY","title":"Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)","description":"SDS is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement. LOCF method was used for analyses.","populationDescription":"ITT Sample included all participants in the Randomized Sample who received at least one dose of double blind trial medication and had at least one post-randomization efficacy evaluation in Phase C. Overall number of participants analyzed are participants with data available for analyses.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Week 8 to Week 14","groups":[{"id":"OG000","title":"Phase C: Aripiprazole/Escitalopram Combination","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated."},{"id":"OG001","title":"Phase C: Escitalopram Monotherapy","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C."},{"id":"OG002","title":"Phase C: Aripiprazole Monotherapy","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"14"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.6","spread":"0.7"},{"groupId":"OG001","value":"-1.8","spread":"0.7"},{"groupId":"OG002","value":"-0.6","spread":"0.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.910","statisticalMethod":"ANCOVA","paramType":"Treatment Difference","paramValue":"0.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.8","ciUpperLimit":"2.1"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.291","statisticalMethod":"ANCOVA","paramType":"Treatment Difference","paramValue":"-1.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.0","ciUpperLimit":"0.9"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)","description":"Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.","eventGroups":[{"id":"EG000","title":"Phase B: Single-blind Prospective Treatment Phase","description":"Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the Week 1 (end of Week 1) based upon tolerability profile, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.","deathsNumAffected":0,"deathsNumAtRisk":137,"seriousNumAffected":0,"seriousNumAtRisk":137,"otherNumAffected":65,"otherNumAtRisk":137},{"id":"EG001","title":"Phase B+: Single-blind Phase B Responders","description":"Participants with response (≥50% reduction in depressive symptom severity in HAM-D17 Total Score; or a HAM-D17 Total Score of \\<14 at Week 8 or a Clinical Global Impression of Improvement (CGI-I) Score of \\<3 at the Week 6 or 8) at the end of the Phase B (Week 8) continued treatment with the single-blind escitalopram monotherapy at the dose (10 or 20 mg/day) taken during the final week of Phase B, for an additional 6 weeks (Up to Week 14), in Phase B+.","deathsNumAffected":0,"deathsNumAtRisk":26,"seriousNumAffected":0,"seriousNumAtRisk":26,"otherNumAffected":4,"otherNumAtRisk":26},{"id":"EG002","title":"Phase C: Aripiprazole/Escitalopram Combination","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.","deathsNumAffected":0,"deathsNumAtRisk":16,"seriousNumAffected":0,"seriousNumAtRisk":16,"otherNumAffected":12,"otherNumAtRisk":16},{"id":"EG003","title":"Phase C: Escitalopram Monotherapy","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.","deathsNumAffected":0,"deathsNumAtRisk":14,"seriousNumAffected":0,"seriousNumAtRisk":14,"otherNumAffected":11,"otherNumAtRisk":14},{"id":"EG004","title":"Phase C: Aripiprazole Monotherapy","description":"Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability.","deathsNumAffected":0,"deathsNumAtRisk":15,"seriousNumAffected":0,"seriousNumAtRisk":15,"otherNumAffected":13,"otherNumAtRisk":15}],"otherEvents":[{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 13.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":137},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAffected":1,"numAtRisk":16},{"groupId":"EG003","numAffected":1,"numAtRisk":14},{"groupId":"EG004","numAffected":3,"numAtRisk":15}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 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13.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":2,"numAtRisk":16},{"groupId":"EG003","numAffected":1,"numAtRisk":14},{"groupId":"EG004","numAffected":1,"numAtRisk":15}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 13.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":137},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":2,"numAtRisk":16},{"groupId":"EG003","numAffected":1,"numAtRisk":14},{"groupId":"EG004","numAffected":1,"numAtRisk":15}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 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13.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":1,"numAtRisk":16},{"groupId":"EG003","numAffected":0,"numAtRisk":14},{"groupId":"EG004","numAffected":0,"numAtRisk":15}]},{"term":"Flatulence","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":16},{"groupId":"EG003","numAffected":0,"numAtRisk":14},{"groupId":"EG004","numAffected":1,"numAtRisk":15}]},{"term":"Salivary hypersecretion","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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13.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":137},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":1,"numAtRisk":16},{"groupId":"EG003","numAffected":0,"numAtRisk":14},{"groupId":"EG004","numAffected":1,"numAtRisk":15}]},{"term":"Bronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":16},{"groupId":"EG003","numAffected":0,"numAtRisk":14},{"groupId":"EG004","numAffected":1,"numAtRisk":15}]},{"term":"Gastroenteritis viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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13.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":137},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":16},{"groupId":"EG003","numAffected":0,"numAtRisk":14},{"groupId":"EG004","numAffected":1,"numAtRisk":15}]},{"term":"Procedural pain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":137},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":1,"numAtRisk":16},{"groupId":"EG003","numAffected":0,"numAtRisk":14},{"groupId":"EG004","numAffected":0,"numAtRisk":15}]},{"term":"Blood creatine phosphokinase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":137},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":16},{"groupId":"EG003","numAffected":0,"numAtRisk":14},{"groupId":"EG004","numAffected":1,"numAtRisk":15}]},{"term":"Blood creatinine increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":137},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":16},{"groupId":"EG003","numAffected":1,"numAtRisk":14},{"groupId":"EG004","numAffected":0,"numAtRisk":15}]},{"term":"Gamma-glutamyltransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 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