Fluoxetine in Pediatric Body Dysmorphic Disorder

Montefiore Medical Center43 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Body Dysmorphic Disorder

Interventions

FluoxetineDRUG

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

PlaceboDRUG

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.

Eligibility

Sex: ALLMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (2)

Montefiore Medical Center, Albert Einstein College of Medicine

The Bronx, New York, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline compared to the study endpoint (week 12) [two time points]

Data from ClinicalTrials.gov

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