Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
Depression, Bipolar
About this trial
This is an interventional treatment trial for Depression, Bipolar focused on measuring Bipolar I disorder, Bipolar depression, Depression, Bipolar disorder
Eligibility Criteria
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 ≥ 20.
- Participants with a HAMD-17 item 1 score ≥ 2.
- 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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
Placebo
Cariprazine 0.75 mg
Cariprazine 1.5 mg
Cariprazine 3.0 mg
Participants received placebo orally once a day for 8 weeks.
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.
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.
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.