Fluoxetine for Anxious Children
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anxiety Disorders
Intervention: Fluoxetine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s):
Boris Birmaher, MD, Principal Investigator
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind
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.
Eligibility
Minimum age: 8 Years.
Maximum age: 17 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: June 1997
Ending date: July 2001
Last updated: December 5, 2005
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