Conditions: Bipolar I Disorder
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 495
Healthy volunteers: no

Brief summary:
The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.

Detailed description:
The study objective is to evaluate the long-term efficacy and safety of SM-13496 (20-120 mg/day) in patients with bipolar I disorder.

Arms:
arm 1: once daily orally SM-13496 20-120 mg flexibly dosed

Interventions: intervention 1: SM-13496
Intervention descriptions: intervention 1: None

Protocol document:
Prot_000.pdf: 































































































































































SAP_001.pdf: