Conditions: Bipolar I Disorder
Keywords: Mania Acute mania Bipolar I disorder
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 403
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.

Detailed description:

Arms:
arm 1: Participants received cariprazine 1.5 mg orally on Day 1 and cariprazine 3.0 mg orally on Days 2 and 3. Starting on Day 4, the dose could be increased in increments of 3 mg every 2 days up to a maximum dose of 12 mg, if the response was not adequate and there were no tolerability issues based on the judgment of the principal investigator.

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

Protocol document: