At a glance
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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
In Brief
A Phase 4 clinical trial evaluating Olanzapine Fluoxetine Combination (OFC) and Placebo for Bipolar Depression. Completed, enrolled 291 participants across 7 sites in 2 countries.
Detailed 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)
Study Details
Timeline
Interventions
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.
Orally, once daily in the evening for 8 weeks.