Conditions: Bipolar Depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 525
Healthy volunteers: no

Brief summary:
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.

Detailed description:
The primary objective is to compare the efficacy of SM-13496 (20-60 or 80-120 mg/day) monotherapy with that of placebo in patients with depressive symptoms associated with bipolar I disorder by assessing the change from baseline in the MADRS total score at Week 6.

Arms:
arm 1: once daily orally arm 2: once daily orally arm 3: once daily orally

Interventions: intervention 1: Placebo intervention 2: SM-13496 intervention 3: SM-13496
Intervention descriptions: intervention 1: Placebo comparator intervention 2: SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6 intervention 3: SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6

Protocol document:
Prot_000.pdf: 























































































































































SAP_001.pdf: