Fluoxetine in Pediatric Body Dysmorphic Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

October 26, 2005

Last Updated Date

December 4, 2007

Start Date ^ICMJE

November 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00245635 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Fluoxetine in Pediatric Body Dysmorphic Disorder

Official Title ^ICMJE

Fluoxetine in Pediatric Body Dysmorphic Disorder

Brief Summary

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

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Body Dysmorphic Disorder

Intervention ^ICMJE

Drug: Fluoxetine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Gender

Both

Ages

10 Years to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Holly Hamilton

(212) 241-3116

holly.hamilton@mssm.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00245635

Responsible Party

Study ID Numbers ^ICMJE

GCO#02-1020, FD-R-002337

Study Sponsor ^ICMJE

Mount Sinai School of Medicine

Collaborators ^ICMJE

Food and Drug Administration (FDA)

Investigators ^ICMJE

Principal Investigator:

Eric Hollander, MD

Mount Sinai School of Medicine

Information Provided By

Mount Sinai School of Medicine

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP