Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
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|ClinicalTrials.gov Identifier: NCT02670551|
Recruitment Status : Completed
First Posted : February 1, 2016
Results First Posted : January 30, 2019
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Depression||Drug: Cariprazine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||488 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating The Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression|
|Actual Study Start Date :||March 17, 2016|
|Actual Primary Completion Date :||July 19, 2017|
|Actual Study Completion Date :||July 19, 2017|
Placebo Comparator: Placebo
Following a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks.
Experimental: Cariprazine 1.5 mg
Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.
Other Name: VRAYLAR®
Experimental: Cariprazine 3.0 mg
Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 milligram (mg) capsule, one per day, orally beginning on Day 15 for 4 weeks.
Other Name: VRAYLAR®
- Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6 [ Time Frame: Baseline (Week 0) to Week 6 ]The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each of the 10 items was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement.
- Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 6 [ Time Frame: Baseline (Week 0) to Week 6 ]The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of other participants the physician has observed. The participant was rated on a scale from 1 to 7, with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A negative change from Baseline indicates improvement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670551
|Study Director:||Clincial Director||Forest Research Institute, Inc., an affiliate of Allergan, plc|