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
  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-Blind
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

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
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, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00000389     History of Changes
Other Study ID Numbers: N01 MH60005, N01 MH60016, DSIR CT
Study First Received: November 2, 1999
Last Updated: June 13, 2007
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:
Anxiety Disorders
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Disease
Anxiety, Separation
Mental Disorders
Personality Disorders
Pathologic Processes
Mental Disorders Diagnosed in Childhood
Therapeutic Uses
Serotonin Uptake Inhibitors
Fluvoxamine
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Psychotropic Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on October 19, 2014