NCT00510146

Olanzapine Treatment of Patients With Bipolar I Disorder

Efficacy and Safety of Olanzapine in the Treatment of Patients With Bipolar I Disorder, Depressed: A Randomized, Double-Blind Comparison With Placebo

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 514 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Conditions

• Depression, Bipolar

Interventions

Type	Name	Description
DRUG	Olanzapine	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).
DRUG	Placebo	placebo tablets, oral, once daily at bedtime, 6 weeks

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-03-01
• Completion: 2010-07-01
• First posted: 2007-08-01
• Last updated: 2011-05-26
• Results posted: 2011-05-26

Locations

16 sites across 3 countries: China, Japan, South Korea