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Treatment for Anxiety in Children - Article


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Fluvoxamine

Luvox


Clinical Trial: Treatment for Anxiety in Children

This study has been completed.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

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

Further Study Details: 

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

- Patients must have: DSM -IV diagnosis of generalized anxiety disorder, social phobia, or separation anxiety.

Location Information

Study chairs or principal investigators

Laurence Greenhill, MD,  Principal Investigator
Mark Riddle, MD,  Principal Investigator

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.

Study ID Numbers:  MH60005; MH60016
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


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Page Updated: June 1, 2005
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