Fluoxetine in Pediatric Body Dysmorphic Disorder (FDA BDD)
This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Fluoxetine in Pediatric Body Dysmorphic Disorder|
- Change in Total Score on the BDD-Y-BOCS Scale [ Time Frame: Baseline compared to the study endpoint (week 12) [two time points] ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2004|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.
Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.
Other Name: Prozac
Placebo Comparator: Placebo
Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245635
|United States, New York|
|Montefiore Medical Center, Albert Einstein College of Medicine|
|Bronx, New York, United States, 10467|
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Eric Hollander, MD||Montefiore Medical Center, Albert Einstein College of Medicine|