Conditions: Depression, Bipolar
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 514
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess whether olanzapine is superior to placebo in patients with bipolar depression.

Detailed description:
1. Dose range and administration mode: Oral Olanzapine 5mg - 20mg/day
2. Duration:

   1. Screening phase is 2-28 days.
   2. Double-blind treatment phase is 6 weeks
   3. Open-label extension phase is 18 weeks

Arms:
arm 1: During double-blind treatment, participants receive olanzapine at a dose of 5 milligram (mg) which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation. arm 2: Matching placebo administered once daily, by mouth during double-blind treatment. arm 3: During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and Week 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.

Interventions: intervention 1: Olanzapine intervention 2: Placebo
Intervention descriptions: intervention 1: 5-20 mg, oral, once daily, for 24 weeks (participants randomized to olanzapine in double-blind treatment period) or 18 weeks (participants randomized to placebo in double-blind treatment period). intervention 2: placebo tablets, oral, once daily at bedtime, 6 weeks

Protocol document: