Conditions: Mania Bipolar I Disorder
Keywords: Acute Mania Bipolar I Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 497
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

Detailed description:

Arms:
arm 1: Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks. arm 2: Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks. arm 3: Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.

Interventions: intervention 1: Cariprazine intervention 2: Placebo
Intervention descriptions: intervention 1: Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. intervention 2: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.

Protocol document: