Fluoxetine in Pediatric Body Dysmorphic Disorder

Body Dysmorphic Disorder Clinical Trial

— FDA BDD  

Official title:

Fluoxetine in Pediatric Body Dysmorphic Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245635
• Other study ID #: 09-10-302
• Secondary ID: 7R01FD002613-04
• Status: Completed
• Phase: Phase 4
• First received: October 26, 2005
• Last updated: March 30, 2018
• Start date: November 2004
• Est. completion date: April 2012

Study information

• Verified date: March 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT00029471

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Dysmorphic Disorder
• Body Dysmorphic Disorders
• Disease

Intervention

Drug:
• Fluoxetine
Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.
• 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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center, Albert Einstein College of Medicine	Bronx	New York
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Score on the BDD-Y-BOCS Scale	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.	Baseline compared to the study endpoint (week 12) [two time points]