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Treatment for Anxiety in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000389
First Posted: November 3, 1999
Last Update Posted: June 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 Intervention Phase
Obsessive-Compulsive Disorder Anxiety Disorders Generalized Anxiety Disorder Social Phobia Separation Anxiety Drug: Fluvoxamine Phase 3

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
- Patients must have: DSM -IV diagnosis of generalized anxiety disorder, social phobia, or separation anxiety.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000389


Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Laurence Greenhill, MD
Principal Investigator: Mark Riddle, MD
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000389     History of Changes
Other Study ID Numbers: N01 MH60005
N01 MH60016
DSIR CT
First Submitted: November 2, 1999
First Posted: November 3, 1999
Last Update Posted: June 14, 2007
Last Verified: November 2005

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:
Disease
Anxiety Disorders
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Phobia, Social
Anxiety, Separation
Pathologic Processes
Mental Disorders
Personality Disorders
Phobic Disorders
Neurodevelopmental Disorders
Serotonin
Fluvoxamine
Serotonin Uptake Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors