Fluoxetine in Pediatric Body Dysmorphic Disorder (FDA BDD)

March 30, 2018 updated by: Eric Hollander, Montefiore Medical Center
This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center, Albert Einstein College of Medicine
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fluoxetine
Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.
Drug: Fluoxetine
Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.
Other Names:
  • 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline compared to the study endpoint (week 12) [two time points]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

Food and Drug Administration (FDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

October 26, 2005

First Submitted That Met QC Criteria

October 26, 2005

First Posted (ESTIMATE)

October 28, 2005

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2018

Last Update Submitted That Met QC Criteria

March 30, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-10-302
  • 7R01FD002613-04 (FDA)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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