Conditions: Acute Bipolar Depression
Keywords: Acute bipolar depression Lithium carbonate quetiapine fumarate MADRS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 421
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.

Detailed description:

Arms:
arm 1: Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. arm 2: Quetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56.

Interventions: intervention 1: Quetiapine fumarate XR intervention 2: Lithium carbonate
Intervention descriptions: intervention 1: Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. intervention 2: Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day

Protocol document: