Treatment of Depression in Youth With Bipolar Disorders

• Status: Terminated
• Trial end date: 2000-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3

Details

• Lead Sponsor: National Institute of Mental Health (NIMH)
• Treatments: Fluoxetine

Criteria

Inclusion Criteria:

• Inclusion Criteria:

• Free of manic symptoms for at least 4 weeks. Must be treated with valproate or lithium (mood stabilizers) for at least 4 weeks. Meet criteria for major depression and bipolar disorder (BP-I, BP-II, or BP-NOS). Not pregnant

Exclusion Criteria:

• Exclusion Criteria:

• Patients with schizophrenia, autism, schizoaffective disorder, organic mood disorder, obsessive-compulsive disorder, eating disorder, and psychosis. IQ less than 70. Significant chronic medical illness such as diabetes, epilepsy. Pregnancy. Substance abuse in last 3 months. Concurrent psychotherapy. Previous lack of response to adequate treatment with fluoxetine or other SSRI. Current use of psychoactive medication other than lithium or valproate.