Fluoxetine in Pediatric Body Dysmorphic Disorder

This study is currently recruiting participants.

Verified by Mount Sinai School of Medicine, December 2007

First Received: October 26, 2005 Last Updated: December 4, 2007 History of Changes

Sponsor:	Mount Sinai School of Medicine
Collaborator:	Food and Drug Administration (FDA)
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00245635

Purpose

This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 10-16 with BDD who qualify.

Condition	Intervention	Phase
Body Dysmorphic Disorder	Drug: Fluoxetine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Fluoxetine in Pediatric Body Dysmorphic Disorder

Resource links provided by NLM:

Drug Information available for: Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:

To assess the efficacy and safety of fluoxetine in the treatment of pediatric body dysmorphic disorder (BDD) via a 13-week double-blind, placebo-controlled parallel group trial at three sites.

Estimated Enrollment:	37
Study Start Date:	November 2004
Estimated Study Completion Date:	December 2008

Detailed Description:

BDD usually begins in childhood or adolescence, but its treatment in pediatric populations has not been investigated. Recent data suggests that adults with BDD may respond to serotonin reuptake inhibitors (SRIs) such as fluoxetine (Prozac). Preliminary findings from case reports suggest that SRIs may also be effective in the treatment of BDD in children and adolescents. This study is the first large-scale, double-blind, placebo-controlled medication trial of fluoxetine for children and adolescents with BDD. Participants should be between the ages of 10-16, and participation in this trial will last approximately 14 weeks.

Eligibility

Ages Eligible for Study:	10 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male or female children and adolescents 10-16 years of age with a diagnosis of BDD

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245635

Contacts

Contact: Holly Hamilton

(212) 241-3116

holly.hamilton@mssm.edu

Locations

United States, Massachusetts
Massachusetts General	Recruiting
Boston, Massachusetts, United States
Contact: Angela Fang 617-643-4779
United States, Ohio
University of Cincinnati	Recruiting
Cincinnati, Ohio, United States
Contact: Judy Depew 513-558-3991 judy.depew@psychiatry.uc.edu
United States, Rhode Island
Butler Hospital	Recruiting
Providence, Rhode Island, United States
Contact: Christine Walters 401-455-6466

Sponsors and Collaborators

Mount Sinai School of Medicine

Food and Drug Administration (FDA)

Investigators

Principal Investigator:

Eric Hollander, MD

Mount Sinai School of Medicine

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	GCO#02-1020, FD-R-002337
Study First Received:	October 26, 2005
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00245635 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:

Body Dsymorphic Disorder
BDD
BDD treatment

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Fluoxetine

Hypochondriasis
Pathologic Processes
Serotonin Agents
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation
Somatoform Disorders
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 05, 2009