NCT00402324

A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients

A Double-Blind Placebo Controlled Trial of Divalproex and Olanzapine in Bipolar I Disorder, Mixed Episode

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I disorder.

Conditions

• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	olanzapine	15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
DRUG	placebo	placebo, capsules, by mouth every evening, daily, for 6 weeks.
DRUG	divalproex	dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 52 days (Study Period I and Study Period II).

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2006-11-22
• Last updated: 2009-06-03
• Results posted: 2009-05-27

Locations

1 site across 1 country: United States