Conditions: Bipolar Depression
Keywords: Bipolar Depression Mental disease,
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 361
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(XR) mono-therapy, administered once daily compared to placebo, in the treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Quetiapine Fumarate (SEROQUEL) Extended Release intervention 2: Placebo
Intervention descriptions: intervention 1: Quetiapine fumarate extended release(XR) will be administered orally, once daily in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after. intervention 2: Placebo matching quetiapine extended release(XR) 50 mg, 200 mg, and 300 mg tablets will be orally administered once daily, in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.

Protocol document: