{"protocolSection":{"identificationModule":{"nctId":"NCT00854100","nctIdAliases":["NCT03605784"],"orgStudyIdInfo":{"id":"RGH-MD-71"},"organization":{"fullName":"Forest Laboratories","class":"INDUSTRY"},"briefTitle":"Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder","officialTitle":"A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2019-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-06-30","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2010-12-06","type":"ACTUAL"},"completionDateStruct":{"date":"2010-12-06","type":"ACTUAL"},"studyFirstSubmitDate":"2009-02-26","studyFirstSubmitQcDate":"2009-02-26","studyFirstPostDateStruct":{"date":"2009-03-02","type":"ESTIMATED"},"resultsFirstSubmitDate":"2018-07-30","resultsFirstSubmitQcDate":"2019-02-12","resultsFirstPostDateStruct":{"date":"2019-03-05","type":"ACTUAL"},"dispFirstSubmitDate":"2012-02-06","dispFirstSubmitQcDate":"2012-02-06","dispFirstPostDateStruct":{"date":"2012-02-08","type":"ESTIMATED"},"lastUpdateSubmitDate":"2019-02-12","lastUpdatePostDateStruct":{"date":"2019-03-05","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Forest Laboratories","class":"INDUSTRY"},"collaborators":[{"name":"Gedeon Richter Ltd.","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Adjunctive","Depression","Major Depressive Disorder (MDD)"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":231,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo","interventionNames":["Drug: Antidepressant + placebo"]},{"label":"Cariprazine 0.1 - 0.3 mg","type":"EXPERIMENTAL","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose","interventionNames":["Drug: Antidepressant + cariprazine (0.1-0.3 mg/day)"]},{"label":"Cariprazine 1.0 - 2.0 mg","type":"EXPERIMENTAL","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose","interventionNames":["Drug: Antidepressant + cariprazine (1-2 mg/d)"]}],"interventions":[{"type":"DRUG","name":"Antidepressant + placebo","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"Antidepressant + cariprazine (0.1-0.3 mg/day)","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.","armGroupLabels":["Cariprazine 0.1 - 0.3 mg"]},{"type":"DRUG","name":"Antidepressant + cariprazine (1-2 mg/d)","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.","armGroupLabels":["Cariprazine 1.0 - 2.0 mg"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Montgomery-Asberg Depression Rating Scale (MADRS)","description":"The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. The primary efficacy parameter was the change in MADRS score totals from the scores taken at Baseline (Week 8) and during at least one more time point up to and including Week 16.","timeFrame":"Baseline (Week 8) to Week 16"}],"secondaryOutcomes":[{"measure":"Clinical Global Impression - Improvement (CGI-I)","description":"The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale that, in this study, will be used to rate total improvement or worsening of mental illness starting at Visit 2 (Week 2) and taken at every visit through Visit 11 (Week 16). The patient will be rated on a scale from 1 to 7, 1 indicating that the patient is very much improved and 7 indicating that the patient is very much worse. The secondary efficacy parameter was the CGI-I total score at Week 16.","timeFrame":"Week 16"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Men and women, 18-65 years old\n* Currently meet the DSM-IV-TR criteria for moderate to severe MDD without psychotic features.\n* Previous failure to respond to adequate trials of one or two ADTs with less than 50% reduction in depressive symptoms during the present episode.\n\nExclusion Criteria:\n\n* DSM-IV-TR based diagnosis of an axis I disorder, other than MDD, or any axis I disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Robert Hayes, PhD","affiliation":"Forest Laboratories","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Forest Investigative Site 040","city":"Phoenix","state":"Arizona","zip":"85050","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Forest Investigative Site 038","city":"Scottsdale","state":"Arizona","zip":"85254","country":"United States","geoPoint":{"lat":33.50921,"lon":-111.89903}},{"facility":"Forest Investigative Site","city":"Arcadia","state":"California","zip":"91007","country":"United States","geoPoint":{"lat":34.13973,"lon":-118.03534}},{"facility":"Forest Investigative Site","city":"Encino","state":"California","zip":"91316","country":"United States","geoPoint":{"lat":34.15917,"lon":-118.50119}},{"facility":"Forest Investigative Site","city":"Garden Grove","state":"California","zip":"92845","country":"United States","geoPoint":{"lat":33.77391,"lon":-117.94145}},{"facility":"Forest Investigative Site","city":"Irvine","state":"California","zip":"92618","country":"United States","geoPoint":{"lat":33.66946,"lon":-117.82311}},{"facility":"Forest Investigative Site 013","city":"Los Alamitos","state":"California","zip":"90720","country":"United States","geoPoint":{"lat":33.80307,"lon":-118.07256}},{"facility":"Forest Investigative Site 041","city":"National City","state":"California","zip":"91950","country":"United States","geoPoint":{"lat":32.67811,"lon":-117.0992}},{"facility":"Forest Investigative Site","city":"Oceanside","state":"California","zip":"92056","country":"United States","geoPoint":{"lat":33.19587,"lon":-117.37948}},{"facility":"Forest Investigative Site 025","city":"Denver","state":"Colorado","zip":"80239","country":"United States","geoPoint":{"lat":39.73915,"lon":-104.9847}},{"facility":"Forest Investigative Site","city":"Norwich","state":"Connecticut","zip":"06360","country":"United States","geoPoint":{"lat":41.52426,"lon":-72.07591}},{"facility":"Forest Investigative Site","city":"Washington D.C.","state":"District of Columbia","zip":"20016","country":"United States","geoPoint":{"lat":38.89511,"lon":-77.03637}},{"facility":"Forest Investigative Site 007","city":"Jacksonville","state":"Florida","zip":"32216","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Forest Investigative Site 012","city":"West Palm Beach","state":"Florida","zip":"33407","country":"United States","geoPoint":{"lat":26.71534,"lon":-80.05337}},{"facility":"Forest Investigative Site 033","city":"Atlanta","state":"Georgia","zip":"30306","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"Forest Investigative Site","city":"Roswell","state":"Georgia","zip":"30076","country":"United States","geoPoint":{"lat":34.02316,"lon":-84.36159}},{"facility":"Forest Investigative Site","city":"Overland Park","state":"Kansas","zip":"66211","country":"United States","geoPoint":{"lat":38.98223,"lon":-94.67079}},{"facility":"Forest Investigative Site 042","city":"Fall River","state":"Massachusetts","zip":"02721","country":"United States","geoPoint":{"lat":41.70149,"lon":-71.15505}},{"facility":"Forest Investigative Site 034","city":"Pittsfield","state":"Massachusetts","zip":"01267","country":"United States","geoPoint":{"lat":42.45008,"lon":-73.24538}},{"facility":"Forest Investigative Site","city":"Omaha","state":"Nebraska","zip":"68131","country":"United States","geoPoint":{"lat":41.25626,"lon":-95.94043}},{"facility":"Forest Investigative Site","city":"Cherry Hill","state":"New Jersey","zip":"08002","country":"United States","geoPoint":{"lat":39.93484,"lon":-75.03073}},{"facility":"Forest Investigative Site 043","city":"Brooklyn","state":"New York","zip":"11235","country":"United States","geoPoint":{"lat":40.6501,"lon":-73.94958}},{"facility":"Forest Investigative Site 020","city":"Mount Kisco","state":"New York","zip":"10549","country":"United States","geoPoint":{"lat":41.20426,"lon":-73.72708}},{"facility":"Forest Investigative Site 039","city":"New York","state":"New York","zip":"10003","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Forest Investigative Site 029","city":"New York","state":"New York","zip":"10021","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Forest Investigative Site 001","city":"The Bronx","state":"New York","zip":"10467","country":"United States","geoPoint":{"lat":40.84985,"lon":-73.86641}},{"facility":"Forest Investigative Site 032","city":"Raleigh","state":"North Carolina","zip":"27607","country":"United States","geoPoint":{"lat":35.7721,"lon":-78.63861}},{"facility":"Forest Investigative Site","city":"Canton","state":"Ohio","zip":"44718","country":"United States","geoPoint":{"lat":40.79895,"lon":-81.37845}},{"facility":"Forest Investigative Site","city":"Dayton","state":"Ohio","zip":"45417","country":"United States","geoPoint":{"lat":39.75895,"lon":-84.19161}},{"facility":"Forest Investigative Site 015","city":"Portland","state":"Oregon","zip":"97210","country":"United States","geoPoint":{"lat":45.52345,"lon":-122.67621}},{"facility":"Forest Investigative Site 006","city":"Media","state":"Pennsylvania","zip":"19063","country":"United States","geoPoint":{"lat":39.91678,"lon":-75.38769}},{"facility":"Forest Investigative Site","city":"Philadelphia","state":"Pennsylvania","zip":"19104","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}},{"facility":"Forest Investigative Site","city":"Philadelphia","state":"Pennsylvania","zip":"19107","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}},{"facility":"Forest Investigative Site 023","city":"Memphis","state":"Tennessee","zip":"38119","country":"United States","geoPoint":{"lat":35.14953,"lon":-90.04898}},{"facility":"Forest Investigative Site 031","city":"Memphis","state":"Tennessee","zip":"38119","country":"United States","geoPoint":{"lat":35.14953,"lon":-90.04898}},{"facility":"Forest Investigative Site","city":"Nashville","state":"Tennessee","zip":"37212","country":"United States","geoPoint":{"lat":36.16589,"lon":-86.78444}},{"facility":"Forest Investigative Site","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Forest Investigative Site","city":"Woodstock","state":"Vermont","zip":"05091","country":"United States","geoPoint":{"lat":43.62424,"lon":-72.51843}},{"facility":"Forest Investigative Site","city":"Richmond","state":"Virginia","zip":"23230","country":"United States","geoPoint":{"lat":37.55376,"lon":-77.46026}},{"facility":"Forest Investigative Site","city":"Bellevue","state":"Washington","zip":"98007","country":"United States","geoPoint":{"lat":47.61038,"lon":-122.20068}},{"facility":"Forest Investigative Site","city":"Seattle","state":"Washington","zip":"98104","country":"United States","geoPoint":{"lat":47.60621,"lon":-122.33207}}]},"referencesModule":{"references":[{"pmid":"30045066","type":"DERIVED","citation":"Fava M, Durgam S, Earley W, Lu K, Hayes R, Laszlovszky I, Nemeth G. Efficacy of adjunctive low-dose cariprazine in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. 2018 Nov;33(6):312-321. doi: 10.1097/YIC.0000000000000235."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The randomized population for RGH-MD-71 totaled 231 participants","groups":[{"id":"FG000","title":"Placebo","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo"},{"id":"FG001","title":"Cariprazine 0.1 - 0.3 mg","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine low dose"},{"id":"FG002","title":"Cariprazine 1.0 - 2.0 mg","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"81"},{"groupId":"FG001","numSubjects":"76"},{"groupId":"FG002","numSubjects":"74"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"72"},{"groupId":"FG001","numSubjects":"70"},{"groupId":"FG002","numSubjects":"63"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"11"}]}],"dropWithdraws":[{"type":"Inability to complete the study visits","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"A total of 231 patients were eligible for randomization to double-blind treatment; 230 patients were randomized and received at least 1 dose of treatment (Double-blind Safety Population)","groups":[{"id":"BG000","title":"Placebo","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo"},{"id":"BG001","title":"Cariprazine 0.1 - 0.3 mg","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose"},{"id":"BG002","title":"Cariprazine 1.0 - 2.0 mg","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"81"},{"groupId":"BG001","value":"76"},{"groupId":"BG002","value":"73"},{"groupId":"BG003","value":"230"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45.2","spread":"10.2"},{"groupId":"BG001","value":"46.6","spread":"11.7"},{"groupId":"BG002","value":"44.2","spread":"12.1"},{"groupId":"BG003","value":"45.3","spread":"11.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"61"},{"groupId":"BG001","value":"52"},{"groupId":"BG002","value":"51"},{"groupId":"BG003","value":"164"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"22"},{"groupId":"BG003","value":"66"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"25"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"74"},{"groupId":"BG001","value":"67"},{"groupId":"BG002","value":"64"},{"groupId":"BG003","value":"205"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"3"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"36"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"69"},{"groupId":"BG001","value":"57"},{"groupId":"BG002","value":"60"},{"groupId":"BG003","value":"186"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"3"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Montgomery-Asberg Depression Rating Scale (MADRS)","description":"The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. The primary efficacy parameter was the change in MADRS score totals from the scores taken at Baseline (Week 8) and during at least one more time point up to and including Week 16.","populationDescription":"231 patients were randomized, and of them, 230 received at least 1 dose of treatment (Double-blind Safety Population), and had at least a baseline and 1 post-baseline MADRS assessment (Double-blind Intent To Treat Population). All patients in the Double-blind Intent To Treat Population were included in the efficacy analyses.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a Scale","timeFrame":"Baseline (Week 8) to Week 16","groups":[{"id":"OG000","title":"Placebo","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo"},{"id":"OG001","title":"Cariprazine 0.1 - 0.3 mg","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine low dose"},{"id":"OG002","title":"Cariprazine 1.0 - 2.0 mg","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"76"},{"groupId":"OG002","value":"73"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.0","spread":"1.0"},{"groupId":"OG001","value":"-7.5","spread":"1.1"},{"groupId":"OG002","value":"-9.8","spread":"1.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.746","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"0.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.4","ciUpperLimit":"3.4"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.227","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-1.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.8","ciUpperLimit":"1.1"}]},{"type":"SECONDARY","title":"Clinical Global Impression - Improvement (CGI-I)","description":"The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale that, in this study, will be used to rate total improvement or worsening of mental illness starting at Visit 2 (Week 2) and taken at every visit through Visit 11 (Week 16). The patient will be rated on a scale from 1 to 7, 1 indicating that the patient is very much improved and 7 indicating that the patient is very much worse. The secondary efficacy parameter was the CGI-I total score at Week 16.","populationDescription":"231 patients were randomized, and of them, 230 received at least 1 dose of treatment (Double-blind Safety Population), and had at least a baseline and 1 post-baseline MADRS assessment (Double-blind Intent To Treat Population). All patients in the Double-blind Intent To Treat Population were included in the efficacy analyses.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a Scale","timeFrame":"Week 16","groups":[{"id":"OG000","title":"Placebo","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo"},{"id":"OG001","title":"Cariprazine 0.1 - 0.3 mg","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine low dose"},{"id":"OG002","title":"Cariprazine 1.0 - 2.0 mg","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"76"},{"groupId":"OG002","value":"73"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.5","spread":"0.1"},{"groupId":"OG001","value":"2.5","spread":"0.1"},{"groupId":"OG002","value":"2.3","spread":"0.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.918","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"0.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.3","ciUpperLimit":"0.3"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.167","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-0.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.6","ciUpperLimit":"0.1"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Up to 20 weeks","description":"Any AE includes the prospective ADT lead-in, double-blind treatment and 30 -day safety follow up will be considered a treatment-emergent adverse event (TEAE). A TEAE that occurs more than 30 days after the last dose of the investigational product will not be summarized for the safety follow-up period.1 patient left the study after they were randomized to the Cariprazine 1.0-2.0 mg arm, but never took the drug. Therefore, that patient is only captured in the lead in period data.","eventGroups":[{"id":"EG000","title":"Prospective Antidepressant-Therapy Lead In Period","description":"Interventions included: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) for 8 weeks prior to randomization","deathsNumAffected":1,"deathsNumAtRisk":502,"seriousNumAffected":9,"seriousNumAtRisk":502,"otherNumAffected":262,"otherNumAtRisk":502},{"id":"EG001","title":"Placebo","description":"Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo for 8 weeks. AE reporting covers this 8 week period plus the 30 day safety follow up that proceeds it.","deathsNumAffected":0,"deathsNumAtRisk":81,"seriousNumAffected":1,"seriousNumAtRisk":81,"otherNumAffected":32,"otherNumAtRisk":81},{"id":"EG002","title":"Cariprazine 0.1 - 0.3 mg","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine low dose for 8 weeks. AE reporting covers this 8 week period plus the 30 day safety follow up that proceeds it.","deathsNumAffected":0,"deathsNumAtRisk":76,"seriousNumAffected":0,"seriousNumAtRisk":76,"otherNumAffected":29,"otherNumAtRisk":76},{"id":"EG003","title":"Cariprazine 1.0 - 2.0 mg","description":"Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose for 8 weeks. AE reporting covers this 8 week period plus the 30 day safety follow up that proceeds it.","deathsNumAffected":0,"deathsNumAtRisk":73,"seriousNumAffected":1,"seriousNumAtRisk":73,"otherNumAffected":35,"otherNumAtRisk":73}],"seriousEvents":[{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Hip Fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Road Traffic Accident","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Upper Limb Fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Suicidal Ideation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Convulsion","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Serotonin Syndrome","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Completed Suicide","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Intentional Overdose","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Alcohol Abuse","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Homicidal Ideation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Suicide Attempt","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Angina Unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":502},{"groupId":"EG001","numAffected":1,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Chronic Obstructive Pulmanary Disease","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":1,"numAtRisk":73}]}],"otherEvents":[{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":73,"numAtRisk":502},{"groupId":"EG001","numAffected":3,"numAtRisk":81},{"groupId":"EG002","numAffected":8,"numAtRisk":76},{"groupId":"EG003","numAffected":6,"numAtRisk":73}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":502},{"groupId":"EG001","numAffected":7,"numAtRisk":81},{"groupId":"EG002","numAffected":4,"numAtRisk":76},{"groupId":"EG003","numAffected":6,"numAtRisk":73}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":502},{"groupId":"EG001","numAffected":3,"numAtRisk":81},{"groupId":"EG002","numAffected":2,"numAtRisk":76},{"groupId":"EG003","numAffected":5,"numAtRisk":73}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":60,"numAtRisk":502},{"groupId":"EG001","numAffected":3,"numAtRisk":81},{"groupId":"EG002","numAffected":2,"numAtRisk":76},{"groupId":"EG003","numAffected":7,"numAtRisk":73}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":502},{"groupId":"EG001","numAffected":5,"numAtRisk":81},{"groupId":"EG002","numAffected":1,"numAtRisk":76},{"groupId":"EG003","numAffected":6,"numAtRisk":73}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":70,"numAtRisk":502},{"groupId":"EG001","numAffected":5,"numAtRisk":81},{"groupId":"EG002","numAffected":5,"numAtRisk":76},{"groupId":"EG003","numAffected":5,"numAtRisk":73}]},{"term":"Dry Mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":502},{"groupId":"EG001","numAffected":1,"numAtRisk":81},{"groupId":"EG002","numAffected":2,"numAtRisk":76},{"groupId":"EG003","numAffected":4,"numAtRisk":73}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":502},{"groupId":"EG001","numAffected":1,"numAtRisk":81},{"groupId":"EG002","numAffected":1,"numAtRisk":76},{"groupId":"EG003","numAffected":4,"numAtRisk":73}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":502},{"groupId":"EG001","numAffected":5,"numAtRisk":81},{"groupId":"EG002","numAffected":4,"numAtRisk":76},{"groupId":"EG003","numAffected":3,"numAtRisk":73}]},{"term":"Upper Respiratory Tract Infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Hyperhidrosis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":502},{"groupId":"EG001","numAffected":0,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":0,"numAtRisk":73}]},{"term":"Akathisia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":502},{"groupId":"EG001","numAffected":3,"numAtRisk":81},{"groupId":"EG002","numAffected":2,"numAtRisk":76},{"groupId":"EG003","numAffected":4,"numAtRisk":73}]},{"term":"Tremor","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":502},{"groupId":"EG001","numAffected":4,"numAtRisk":81},{"groupId":"EG002","numAffected":0,"numAtRisk":76},{"groupId":"EG003","numAffected":4,"numAtRisk":73}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":502},{"groupId":"EG001","numAffected":3,"numAtRisk":81},{"groupId":"EG002","numAffected":1,"numAtRisk":76},{"groupId":"EG003","numAffected":4,"numAtRisk":73}]},{"term":"Restlessness","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":502},{"groupId":"EG001","numAffected":1,"numAtRisk":81},{"groupId":"EG002","numAffected":1,"numAtRisk":76},{"groupId":"EG003","numAffected":7,"numAtRisk":73}]},{"term":"Increased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":502},{"groupId":"EG001","numAffected":1,"numAtRisk":81},{"groupId":"EG002","numAffected":1,"numAtRisk":76},{"groupId":"EG003","numAffected":5,"numAtRisk":73}]},{"term":"Arthralgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":502},{"groupId":"EG001","numAffected":1,"numAtRisk":81},{"groupId":"EG002","numAffected":4,"numAtRisk":76},{"groupId":"EG003","numAffected":1,"numAtRisk":73}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc"},"pointOfContact":{"title":"Therapeutic Area Head","organization":"Allergan, Inc","email":"IR-CTRegistration@allergan.com","phone":"877-277-8566"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000928","term":"Antidepressive Agents"},{"id":"C533287","term":"cariprazine"}],"ancestors":[{"id":"D011619","term":"Psychotropic Drugs"},{"id":"D002491","term":"Central Nervous System Agents"},{"id":"D045506","term":"Therapeutic Uses"},{"id":"D020228","term":"Pharmacologic Actions"},{"id":"D020164","term":"Chemical Actions and Uses"}]}},"hasResults":true}