{"protocolSection":{"identificationModule":{"nctId":"NCT01838876","orgStudyIdInfo":{"id":"RGH-MD-76"},"organization":{"fullName":"Forest Laboratories","class":"INDUSTRY"},"briefTitle":"Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder","officialTitle":"A Phase 3, Long-term, Open-label Study of Safety and Tolerability of Cariprazine as Adjunctive Therapy in Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2019-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-04-29","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2015-07-27","type":"ACTUAL"},"completionDateStruct":{"date":"2015-07-27","type":"ACTUAL"},"studyFirstSubmitDate":"2013-04-22","studyFirstSubmitQcDate":"2013-04-23","studyFirstPostDateStruct":{"date":"2013-04-24","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-07-29","resultsFirstSubmitQcDate":"2019-07-29","resultsFirstPostDateStruct":{"date":"2019-08-21","type":"ACTUAL"},"dispFirstSubmitDate":"2016-08-02","dispFirstSubmitQcDate":"2016-08-02","dispFirstPostDateStruct":{"date":"2016-08-04","type":"ESTIMATED"},"lastUpdateSubmitDate":"2019-07-29","lastUpdatePostDateStruct":{"date":"2019-08-21","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Forest Laboratories","class":"INDUSTRY"},"collaborators":[{"name":"Gedeon Richter Ltd.","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The objective of this study is to evaluate the long-term safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD)."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Major Depressive Disorder","MDD","Depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":442,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Cariprazine + ADT","type":"EXPERIMENTAL","description":"Cariprazine, flexible dose (titrated to a dose of 3.0 milligrams (mg) adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.","interventionNames":["Drug: Cariprazine","Drug: Antidepressant Therapy (ADT)"]}],"interventions":[{"type":"DRUG","name":"Cariprazine","description":"Cariprazine capsules 0.5 mg, 1.0 mg, and 1.5 mg; Cariprazine doses 1.5, 3.0, or 4.5 mg/day (d); patients will be titrated to a starting dose of 3.0 mg/d. Patients can stay on 3.0 mg/d or the dose can be adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability. Oral administration.","armGroupLabels":["Cariprazine + ADT"]},{"type":"DRUG","name":"Antidepressant Therapy (ADT)","description":"ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its respective FDA approved package insert for each drug","armGroupLabels":["Cariprazine + ADT"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period","description":"An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. 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An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A NEAE is a new AE that occurred during the 2-week Safety Follow-up Period.","timeFrame":"2 weeks following the 26-week Treatment Period"},{"measure":"Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters","description":"Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance.","timeFrame":"Baseline (Week 0) to up to 26 weeks in the Treatment Period"},{"measure":"Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters","description":"Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance.","timeFrame":"Baseline (Week 0) to up to 26 weeks in the Treatment Period plus a 2-week Safety Follow-up Period (Up to 28 weeks)"},{"measure":"Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)","description":"A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report.","timeFrame":"Baseline (Week 0) to up to 26 weeks"},{"measure":"Number of Participants With Extrapyramidal Symptom (EPS)-Related TEAEs","description":"Extrapyramidal symptoms are drug-induced movement disorders such as dystonia, akathisia, parkinsonism, bradykinesia, tremor, and tardive dyskinesia.","timeFrame":"First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks)"},{"measure":"Number of Participants in the Most Severe Suicidal Ideation and Suicidal Behavior Recorded on the C-SSRS During the Treatment Period","description":"The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent). The C-SSRS also captures information about the intensity of ideation, specifically the frequency, duration, controllability, deterrents, and reasons for the most severe types of ideation. Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior to 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes.","timeFrame":"Baseline (Lead-in study Baseline for roll-over participants and prior to first dose in this study for new participants) to Week 26 in this study"},{"measure":"Number of Participants With Treatment-Emergent Ocular Events","description":"A TEAE is an AE that occurs or worsens after receiving study drug. 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New patients were eligible if they had an ongoing inadequate response to a protocol-allowed antidepressant therapy (ADT).","groups":[{"id":"FG000","title":"Cariprazine + ADT","description":"Cariprazine, flexible dose (titrated to a dose of 3.0milligrams (mg) adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"442"}]},{"type":"Safety Population; Received Study Drug","achievements":[{"groupId":"FG000","numSubjects":"345"}]},{"type":"Entered Safety Follow-up Period","achievements":[{"groupId":"FG000","numSubjects":"287"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"209"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"233"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"49"}]},{"type":"Insufficient Therapeutic Response","reasons":[{"groupId":"FG000","numSubjects":"10"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"34"}]},{"type":"Withdrawal of Consent","reasons":[{"groupId":"FG000","numSubjects":"33"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"21"}]},{"type":"Study or Site Terminated by Sponsor","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Reason not Specified","reasons":[{"groupId":"FG000","numSubjects":"7"}]},{"type":"Did not meet eligibility criteria","reasons":[{"groupId":"FG000","numSubjects":"78"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.","groups":[{"id":"BG000","title":"Cariprazine + ADT","description":"Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"345"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.7","spread":"10.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"249"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"96"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Race","categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"280"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"54"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"6"}]},{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"3"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Ethnicity","categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"75"}]},{"title":"Non-Hispanic or Latino","measurements":[{"groupId":"BG000","value":"270"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period","description":"An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. 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A TEAE is an AE that occurs or worsens after receiving study drug.","populationDescription":"Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"First dose of study drug to last dose of study drug in the 26-week Treatment Period and within 30 days of last dose of study drug for participants who did not participate in the 2-week Safety Follow-up Period (Up to 30 weeks)","groups":[{"id":"OG000","title":"Cariprazine + ADT","description":"Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"345"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"274"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Newly Emergent Adverse Events (NEAEs) in the Safety Follow-up Period","description":"An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A NEAE is a new AE that occurred during the 2-week Safety Follow-up Period.","populationDescription":"Participants in the Safety Population, all participants in the enrolled population who took at least 1 dose of cariprazine in this study, who entered the Safety Follow-up period.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"2 weeks following the 26-week Treatment Period","groups":[{"id":"OG000","title":"Cariprazine + ADT","description":"Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"287"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters","description":"Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. 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The investigator assessed the results for clinical significance.","populationDescription":"Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline (Week 0) to up to 26 weeks in the Treatment Period plus a 2-week Safety Follow-up Period (Up to 28 weeks)","groups":[{"id":"OG000","title":"Cariprazine + ADT","description":"Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"345"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)","description":"A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report.","populationDescription":"Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline (Week 0) to up to 26 weeks","groups":[{"id":"OG000","title":"Cariprazine + ADT","description":"Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"345"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Extrapyramidal Symptom (EPS)-Related TEAEs","description":"Extrapyramidal symptoms are drug-induced movement disorders such as dystonia, akathisia, parkinsonism, bradykinesia, tremor, and tardive dyskinesia.","populationDescription":"Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks)","groups":[{"id":"OG000","title":"Cariprazine + ADT","description":"Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"345"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"98"}]}]}]},{"type":"PRIMARY","title":"Number of Participants in the Most Severe Suicidal Ideation and Suicidal Behavior Recorded on the C-SSRS During the Treatment Period","description":"The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent). The C-SSRS also captures information about the intensity of ideation, specifically the frequency, duration, controllability, deterrents, and reasons for the most severe types of ideation. Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior to 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes.","populationDescription":"Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline (Lead-in study Baseline for roll-over participants and prior to first dose in this study for new participants) to Week 26 in this study","groups":[{"id":"OG000","title":"Cariprazine + ADT","description":"Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"345"}]}],"classes":[{"title":"No Suicidal Ideation","categories":[{"measurements":[{"groupId":"OG000","value":"308"}]}]},{"title":"Suicidal Ideation","categories":[{"measurements":[{"groupId":"OG000","value":"37"}]}]},{"title":"Suicidal Ideation with Specific Plan and Intent","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Ideation,Some Intent to Act,without Specific Plan","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Ideation,any Methods,without Intent to Act","categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]},{"title":"Non-specific Active Suicidal Thoughts","categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"Wish to be Dead","categories":[{"measurements":[{"groupId":"OG000","value":"27"}]}]},{"title":"No Suicidal Behavior","categories":[{"measurements":[{"groupId":"OG000","value":"344"}]}]},{"title":"Suicidal Behavior","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Completed Suicide","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Actual Suicide Attempt","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Treatment-Emergent Ocular Events","description":"A TEAE is an AE that occurs or worsens after receiving study drug. 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There are different forms for males and females. 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flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigators judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks for male participants."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"88"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"20.1","spread":"5.9"},{"groupId":"OG001","value":"17.2","spread":"5.5"}]}]},{"title":"Change from Baseline to the End of Treatment","categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"4.4"},{"groupId":"OG001","value":"-0.1","spread":"4.6"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the 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The sponsor cannot require changes to the communication and cannot extend the embargo."},"pointOfContact":{"title":"Therapeutic Area, Head","organization":"Allergan","email":"clinicaltrials@allergan.com","phone":"714-246-4500"}}},"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":"C533287","term":"cariprazine"}]}},"hasResults":true}