NCT00245635

Fluoxetine in Pediatric Body Dysmorphic Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Body Dysmorphic Disorder

Interventions

Type	Name	Description
DRUG	Fluoxetine	Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.
DRUG	Placebo	Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score.

Timeline

• Start date: 2004-11-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2005-10-28
• Last updated: 2018-04-27
• Results posted: 2015-06-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study