MedTrace Logo

Fluoxetine for Anxious Children

NCT00000381 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-01-08

No results posted yet for this study

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.

Conditions

  • Anxiety Disorders

Interventions

DRUG

Fluoxetine

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Boris Birmaher, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

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

Timeline & Regulatory

Start
1997-06-30
Primary Completion
2003-05-31
Completion
2003-05-31

More Related Trials

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 NCT00000381 on ClinicalTrials.gov