NCT00844857

A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression

Study to Assess the Efficacy and Safety of Olanzapine and Fluoxetine Combination Versus Placebo in Patients Ages 10-17 in the Treatment of Major Depressive Episodes Associated With Bipolar I Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this study is to help answer the following research question(s) and not to treat the child's illness. * Can this study drug make children with bipolar depression feel better? * Does this study drug work better than a placebo (sugar pill)? * Does this study drug cause side effects in children who take it? * Is this drug safe to use in children? (The study drug is a mixture of olanzapine and fluoxetine)

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	Olanzapine Fluoxetine Combination (OFC)	OFC doses are capsules of 3 milligrams (mg) olanzapine and 25 mg fluoxetine (3/25), 6/25, 12/25, 6/50, or 12/50 mg to be taken orally once daily in the evening for 8 weeks.
DRUG	Placebo	Orally, once daily in the evening for 8 weeks.

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2009-02-16
• Last updated: 2013-02-18
• Results posted: 2013-02-18

Locations

7 sites across 2 countries: United States, Russia