Overview

Fluoxetine for Anxious Children

Status:
Completed

Trial end date:
2003-05-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to see if it is safe and effective to use fluoxetine to treat children and adolescents with Generalized Anxiety Disorder (GAD). Anxiety disorders are one of the most common psychiatric disorders in children and adolescents, and can cause disturbances in the child's school, social, and family lives. Having an anxiety disorder puts a child at risk for depression and drug abuse, and appears to continue into adulthood. There is very little information on anxiety medications for children. Children will be assigned randomly (like tossing a coin) to receive either fluoxetine or an inactive placebo for 12 weeks. Each child will be monitored for symptoms and side effects throughout the study. He/she will have blood tests at Weeks 4, 8, and 12 to measure drug levels in the blood. The study will last for 12 weeks. A child is eligible for this study if he/she: Is 8 to 17 years old and has anxiety disorder. A child will not be eligible for this study if he/she: Has current major depression, panic disorder, or obsessive-compulsive disorder, or abuses alcohol or drugs.

Phase:

Phase 3

Details

Lead Sponsor:

University of Pittsburgh

Collaborator:

National Institute of Mental Health (NIMH)

Treatments:

Fluoxetine
Serotonin
Serotonin Uptake Inhibitors

Criteria

Inclusion Criteria:

-

Patients must have:

Generalized anxiety disorder.

Exclusion Criteria:

-

Excluded:

Patients with current major depression, as well as patients with panic and
obsessive-compulsive disorder.

-

Excluded:

Current substance abuse.