Who is sponsoring NCT00844857?

NCT00844857 is sponsored by Eli Lilly and Company.

What condition does NCT00844857 study?

NCT00844857 studies Bipolar Depression.

What drugs are being tested in NCT00844857?

Interventions: Olanzapine Fluoxetine Combination (OFC), Placebo.

What is the status of NCT00844857?

NCT00844857 is currently COMPLETED.

Last reviewed 2013-01-16 · How we verify

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

NCT00844857 Phase 4 COMPLETED Results posted

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)

Details

Lead sponsor	Eli Lilly and Company
Phase	Phase 4
Status	COMPLETED
Enrolment	291
Start date	2009-04
Completion	2012-02

Conditions

Bipolar Depression

Interventions

Olanzapine Fluoxetine Combination (OFC)
Placebo

Primary outcomes

Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8 — Baseline, Week 8
CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) mean was adjusted for baseline, country, treatment, visit, and treatment times (\*) visit interaction.

Countries

United States, Russia