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

Bipolar Depression Clinical Trial

Official title:
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

Clinical Trial 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)

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00844857
Study type Interventional
Source Eli Lilly and Company
Contact
Status Completed
Phase Phase 4
Start date April 2009
Completion date February 2012
View Details
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