Fluoxetine for Anxious Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000381
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : January 8, 2014
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boris Birmaher, MD, University of Pittsburgh

Brief 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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Drug: Fluoxetine Phase 3

Detailed Description:

To evaluate the safety and efficacy of fluoxetine as a treatment for children and adolescents with Generalized Anxiety Disorder (GAD).

Anxiety disorders are among the most common childhood and adolescent psychiatric disorders and are often associated with academic, social, and family morbidity. These disorders frequently increase the risk for developing other psychiatric disorders (e.g., depression, substance abuse), aggregate in families, and appear to continue into adulthood. Except for Obsessive-Compulsive Disorder, there are very few pharmacological treatment studies for childhood anxiety disorders. Given the sparsity and methodological problems of previous anxiety pharmacological studies, it is clear that further investigation of the use of pharmacological treatment of children and adolescents with these disorders is needed.

Patients are randomized to receive either fixed-dose fluoxetine or placebo for 12 weeks. Patients are assessed for psychiatric symptomatology, functional status, and side effects. In addition, to assess attainment of steady state and compliance with treatment, plasma levels of fluoxetine and norfluoxetine are measured at 4, 8, and 12 weeks. To standardize the treatment protocol and to assure that both groups (fluoxetine and placebo) receive equivalent nonpharmacological treatment, a manual is used. Potential predictors of clinical response (such as age, sex, duration and severity of anxiety, school absenteeism, sub-syndromal depressive symptoms, family history of anxiety or mood disorders) are explored.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : June 1997
Actual Primary Completion Date : May 2003
Actual Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Fluoxetine

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All

Inclusion Criteria:

Patients must have:

Generalized anxiety disorder.

Exclusion Criteria:


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


Current substance abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000381

Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Boris Birmaher, MD

Publications of Results:
Responsible Party: Boris Birmaher, MD, Professor of Psychiatry, University of Pittsburgh Identifier: NCT00000381     History of Changes
Other Study ID Numbers: R01MH053681 ( U.S. NIH Grant/Contract )
R01MH053681 ( U.S. NIH Grant/Contract )
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: December 2005

Keywords provided by Boris Birmaher, MD, University of Pittsburgh:
Anxiety Disorders
Serotonin Uptake Inhibitors
Anxiety Disorders -- *drug therapy
Fluoxetine -- *therapeutic use
Serotonin Uptake Inhibitors -- *therapeutic use

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin Receptor Agonists