Conditions: Bipolar Disorder
Keywords: Mania Bipolar I Disorder Acute Mania Associated with Bipolar I Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 238
Healthy volunteers: no

Brief summary:
This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of two treatment groups: RGH-188 or placebo

Detailed description:

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

Interventions: intervention 1: Cariprazine (RGH-188) intervention 2: Placebo
Intervention descriptions: intervention 1: Cariprazine 3 mg - 12 mg oral administration, once per day. intervention 2: Dose-matched placebo oral administration, once per day.

Protocol document: