Fluoxetine for Anxious Children
Primary Purpose
Anxiety Disorders
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Fluoxetine
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders focused on measuring Adolescence, Anxiety Disorders, Child, Female, Fluoxetine, Male, Placebos, Serotonin Uptake Inhibitors, Anxiety Disorders -- *drug therapy, Fluoxetine -- *therapeutic use, Serotonin Uptake Inhibitors -- *therapeutic use
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000381
First Posted
November 2, 1999
Last Updated
January 7, 2014
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00000381
Brief Title
Fluoxetine for Anxious Children
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
June 1997 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Adolescence, Anxiety Disorders, Child, Female, Fluoxetine, Male, Placebos, Serotonin Uptake Inhibitors, Anxiety Disorders -- *drug therapy, Fluoxetine -- *therapeutic use, Serotonin Uptake Inhibitors -- *therapeutic use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Birmaher, MD
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
12649628
Citation
Birmaher B, Axelson DA, Monk K, Kalas C, Clark DB, Ehmann M, Bridge J, Heo J, Brent DA. Fluoxetine for the treatment of childhood anxiety disorders. J Am Acad Child Adolesc Psychiatry. 2003 Apr;42(4):415-23. doi: 10.1097/01.CHI.0000037049.04952.9F.
Results Reference
result
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Fluoxetine for Anxious Children
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