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Treatment for Anxiety in Children

Information source: National Institute of Mental Health (NIMH)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obsessive-Compulsive Disorder; Anxiety Disorders; Generalized Anxiety Disorder; Social Phobia; Separation Anxiety

Intervention: Fluvoxamine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
Laurence Greenhill, MD, Principal Investigator
Mark Riddle, MD, Principal Investigator

Summary

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).

Clinical Details

Official title: Research Unit on Pediatric Psychopharmacology Anxiety Treatment Study

Study design: Masking: Double-Blind, Primary Purpose: Treatment

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

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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

separation anxiety.

Locations and Contacts

Additional Information

Related publications:

Fluvoxamine for the treatment of anxiety disorders in children and adolescents. The Research Unit on Pediatric Psychopharmacology Anxiety Study Group. N Engl J Med. 2001 Apr 26;344(17):1279-85.

Coyle JT. Drug treatment of anxiety disorders in children. N Engl J Med. 2001 Apr 26;344(17):1326-7.

Starting date: October 1996
Last updated: June 13, 2007

Page last updated: August 23, 2015

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