Clinical Trial: Fluoxetine in Pediatric Body Dysmorphic Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Fluoxetine in Pediatric Body Dysmorphic Disorder

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 Summary: 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.
Sponsor: Montefiore Medical Center

Current Primary Outcome: Change in Total Score on the BDD-Y-BOCS Scale [ Time Frame: 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.


Original Primary Outcome: 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.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Montefiore Medical Center

Dates:
Date Received: October 26, 2005
Date Started: November 2004
Date Completion:
Last Updated: July 6, 2015
Last Verified: July 2015