A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar Depression
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 584
- Locations
- 88
- Primary Endpoint
- Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6
Study Overview
Brief Summary
The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants who have provided informed consent prior to any study specific procedures.
- •Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
- •Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
- •Verified previous manic or mixed episode.
- •Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥
- •Participants with a HAMD-17 item 1 score ≥
- •Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.
Exclusion Criteria
- •Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.
- •Women who are pregnant or breast feeding
- •Participants with Young Mania Rating Scale (YMRS) total score > 10
- •Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.
Arms & Interventions
Placebo
Participants received placebo orally once a day for 8 weeks.
Intervention: Placebo (Drug)
Cariprazine 0.75 mg
Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
Intervention: Cariprazine (Drug)
Cariprazine 1.5 mg
Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
Intervention: Cariprazine (Drug)
Cariprazine 3.0 mg
Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
Intervention: Cariprazine (Drug)
Outcomes
Primary Outcomes
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6
Time Frame: Baseline to Week 6
The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The scores on the 10 items are summed for a total score that can range from 0 to 60. A higher score indicates greater depression. A negative change score indicates improvement.
Secondary Outcomes
- Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6(Baseline to Week 6)