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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)
ClinicalTrials.gov Identifier: NCT00000389
  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 Intervention Phase
Obsessive-Compulsive Disorder
Anxiety Disorders
Generalized Anxiety Disorder
Social Phobia
Separation Anxiety
Drug: Fluvoxamine
Phase III

MedlinePlus related topics:   Anxiety    Obsessive-Compulsive Disorder    Phobias   

Drug Information available for:   Serotonin    Fluvoxamine maleate    Fluvoxamine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Placebo Control
Official Title:   Research Unit on Pediatric Psychopharmacology Anxiety Treatment Study

Further study details as provided by National Institute of Mental Health (NIMH):

Study Start Date:   October 1996
Estimated Study Completion Date:   November 1999

Detailed Description:

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 to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000389

Sponsors and Collaborators

Investigators
Principal Investigator:     Laurence Greenhill, MD    
Principal Investigator:     Mark Riddle, MD    
  More Information


Publications:

Study ID Numbers:   N01 MH60005, N01 MH60016, DSIR CT
First Received:   November 2, 1999
Last Updated:   June 13, 2007
ClinicalTrials.gov Identifier:   NCT00000389
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Adolescence  
Anxiety Disorders  
Child  
Female  
Fluvoxamine  
Human  
Male
Serotonin Uptake Inhibitors
Anxiety Disorders -- *drug therapy
Fluvoxamine -- *therapeutic use
Serotonin Uptake Inhibitors -- *therapeutic use

Study placed in the following topic categories:
Fluvoxamine
Anxiety Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Anxiety, Separation
Phobic Disorders
Serotonin
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Pathologic Processes
Therapeutic Uses
Anti-Anxiety Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on December 03, 2008




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