Fluvoxamine |
Luvox |
Clinical Trial: Treatment for Anxiety in Children
This study has been completed.
|
Purpose
The purpose of this study is to see if it is effective to treat children with anxiety disorders with fluvoxamine.
Fluvoxamine has been successfully used to treat obsessive-compulsive disorder (OCD) in adults and children. Anxiety disorders other than OCD, such as generalized anxiety disorder, social phobia, or separation anxiety, are very common in youth and are not always responsive to behavioral therapies alone. These disorders may respond to fluvoxamine.
A child will be evaluated for 3 weeks before he/she is assigned randomly (like tossing a coin) to receive either fluvoxamine or an inactive placebo for 8 weeks. After this double-blind phase (neither the child/parents nor the doctor know which treatment is being given), the child will have the option of continuing treatment during a 4-month open-label extension period (both the child/parents and the doctor know which the child is receiving).
A child may be eligible for this study if he/she: Is 6 to 17 years old and has been diagnosed with an anxiety disorder (i.e., generalized anxiety disorder, social phobia, or separation anxiety).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Obsessive-Compulsive Disorder Anxiety Disorders Generalized Anxiety Disorder Social Phobia Separation Anxiety | Drug: Fluvoxamine | Phase III |
MedlinePlus related topics: Anxiety; Mental Health; Obsessive-Compulsive Disorder; Phobias
Study Type: Interventional
Study Design: Treatment, Double-Blind, Placebo Control
Official Title: Research Unit on Pediatric Psychopharmacology Anxiety Treatment Study
Study start: October 1996; Study completion: November 1999
To evaluate fluvoxamine in the treatment of children and adolescents with anxiety disorders.
Fluvoxamine is a serotonin reuptake inhibitor that is FDA-approved for the treatment of obsessive-compulsive disorder (OCD) in adults and children. Anxiety disorders other than OCD are very common in youth and are not always responsive to psychosocial therapies. Fluvoxamine is an alternative treatment.
After a 3-week period of evaluation, patients meeting study entry criteria are randomized to receive either fluvoxamine or placebo for 8 weeks. After this double-blind phase, patients can enter a 4-month open-label extension.
Eligibility
Ages Eligible for Study: 6 Years - 17 Years, Genders Eligible for Study: Both
Criteria
Location Information
More Information
http://www.nimh.nih.gov/events/prrupp.cfm
Publications
[No authors listed] Fluvoxamine for the treatment of anxiety disorders in children and adolescents. The Research Unit on Pediatric Psychopharmacology Anxiety Study Group. N Engl J Med. 2001 Apr 26;344(17):1279-85.
Coyle JT. Drug treatment of anxiety disorders in children. N Engl J Med. 2001 Apr 26;344(17):1326-7. No abstract available.
Record last reviewed: November 2004
Last Updated: November 17, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00000389
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Not Signed In -


