Depression, Bipolar Clinical Trial
Official title:
Efficacy and Safety of Olanzapine in the Treatment of Patients With Bipolar I Disorder, Depressed: A Randomized, Double-Blind Comparison With Placebo
The purpose of this study is to assess whether olanzapine is superior to placebo in patients with bipolar depression.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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