Treatment for Anxiety in Children

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00000389
First received: November 2, 1999
Last updated: June 13, 2007
Last verified: November 2005

November 2, 1999
June 13, 2007
October 1996
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Complete list of historical versions of study NCT00000389 on ClinicalTrials.gov Archive Site
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Treatment for Anxiety in Children
Research Unit on Pediatric Psychopharmacology Anxiety Treatment Study

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).

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.

Interventional
Phase 3
Masking: Double-Blind
Primary Purpose: Treatment
  • Obsessive-Compulsive Disorder
  • Anxiety Disorders
  • Generalized Anxiety Disorder
  • Social Phobia
  • Separation Anxiety
Drug: Fluvoxamine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 1999
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- Patients must have: DSM -IV diagnosis of generalized anxiety disorder, social phobia, or separation anxiety.

Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00000389
N01 MH60005, N01 MH60016, DSIR CT
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National Institute of Mental Health (NIMH)
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Principal Investigator: Laurence Greenhill, MD
Principal Investigator: Mark Riddle, MD
National Institute of Mental Health (NIMH)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP