Conditions: Depression, Bipolar
Keywords: Bipolar I disorder Bipolar depression Depression Bipolar disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 584
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Participants received placebo orally once a day for 8 weeks. arm 2: 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. arm 3: 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. arm 4: 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.

Interventions: intervention 1: Placebo intervention 2: Cariprazine
Intervention descriptions: intervention 1: Placebo was supplied in capsules. intervention 2: Cariprazine was supplied in capsules.

Protocol document: