Conditions: Bipolar Depression
Keywords: bipolar depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 234
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.

Detailed description:

Arms:
arm 1: 0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing. arm 2: 1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing. arm 3: Matching placebo capsules, oral administration, once daily dosing.

Interventions: intervention 1: cariprazine intervention 2: cariprazine intervention 3: placebo
Intervention descriptions: intervention 1: Drug: cariprazine (0.25 - 0.75 mg/day) intervention 2: Drug: cariprazine (1.5 - 3.0 mg/day) intervention 3: placebo capsules, oral administration, once daily dosing

Protocol document: