NCT00005015

Brief 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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2000

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2000

Completed
Last Updated

November 21, 2005

Status Verified

November 1, 2000

First QC Date

March 31, 2000

Last Update Submit

November 17, 2005

Conditions

Bipolar DisorderDepression

Keywords

Bipolar DisorderDepressionFluoxetine

Interventions

FluoxetineDRUG

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Bipolar DisorderDepression

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 31, 2000

First Posted

April 3, 2000

Study Completion

September 1, 2000

Last Updated

November 21, 2005

Record last verified: 2000-11