Fluoxetine in Pediatric Body Dysmorphic Disorder

Phase 4

Completed

• Conditions: Body Dysmorphic Disorder
• Interventions: Drug: Fluoxetine; Drug: Placebo

• Registration Number: NCT00245635
• Lead Sponsor: Montefiore Medical Center

Brief Summary

This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger 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 aged 16 or younger. Participation in this trial will last approximately 14 weeks.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-10-26
• Study First Submitted QC: 2005-10-26
• Study First Posted: 2005-10-28
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2015-04-21
• Results First Submitted QC: 2015-06-09
• Results First Posted: 2015-06-29
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-30
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Male or female children and adolescents aged 16 and younger
• BDD or its delusional variant present currently and for at least 6 months prior to the study
• Ability to communicate meaningfully with the investigators and competent to provide written assent

Exclusion Criteria

• Presence of Schizophrenia or Bipolar Disorder
• Recent suicide attempt or suicidal ideations that warrant hospitalizations
• Previous allergic reaction to fluoxetine
• History of a seizure disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoxetine	Fluoxetine	Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.
Placebo	Placebo	Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.

Primary Outcome Measures

Name	Time	Method
Change in Total Score on the BDD-Y-BOCS Scale	Baseline compared to the study endpoint (week 12) [two time points]	To assess the change in total score on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS) from baseline (visit 0) to endpoint (week 12). This is a 12-item scale that assesses obsessions and compulsions related to the patient's BDD. Each item's score ranges from 0 to 4, with a total possible score of 48 on the full assessment. Scores of 0 indicate no impairment, while scores of 4 indicate maximum impairment. Thus higher scores are considered to be a worse outcome.

Trial Locations

Locations (2)

Montefiore Medical Center, Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States