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Treatment of Depression in Youth With Bipolar Disorders

NCT00005015 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2005-11-21

No results posted yet for this study

Summary

THIS STUDY HAS BEEN DISCONTINUED.

The study is designed to evaluate the safety and efficacy of fluoxetine for treating children and adolescents with Bipolar Disorder who are experiencing an episode of major depression while being treated with a mood stabilizer. The study involves a 2-week assessment period. Patients who are on stable, therapeutic doses of lithium or valproate and continue to have depression will be randomized to a 12-week treatment of fluoxetine or placebo. Those who respond favorably to treatment will be followed openly for an 18-week continuation phase.

Conditions

Interventions

DRUG

Fluoxetine

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Study Design

Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2000-09-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00005015 on ClinicalTrials.gov