Full Text View
Tabular View
No Study Results Posted
Related Studies
Treatment for Anxiety in Children
This study has been completed.
First Received: November 2, 1999   Last Updated: June 13, 2007   History of Changes
Sponsor: 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

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

Resource links provided by NLM:


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
Study First Received: November 2, 1999
Last Updated: June 13, 2007
ClinicalTrials.gov Identifier: NCT00000389     History of Changes
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

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Fluvoxamine
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Phobic Disorders
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Anti-Anxiety Agents
Anxiety, Separation
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents
Obsessive-Compulsive Disorder

ClinicalTrials.gov processed this record on November 27, 2009