Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Fluoxetine in Pediatric Body Dysmorphic Disorder (FDA BDD)

This study has been completed.
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Montefiore Medical Center Identifier:
First received: October 26, 2005
Last updated: February 4, 2013
Last verified: November 2012

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

Condition Intervention Phase
Body Dysmorphic Disorder
Drug: Fluoxetine
Drug: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Safety and Efficacy [ Time Frame: Each study week and end of study ] [ Designated as safety issue: Yes ]
    To assess the efficacy and safety of fluoxetine in the treatment of pediatric body dysmorphic disorder (BDD) via a 13-week double-blind, placebo-controlled parallel group trial at two sites.

Enrollment: 17
Study Start Date: November 2004
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.
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.

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.


Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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
Sponsors and Collaborators
Montefiore Medical Center
Food and Drug Administration (FDA)
Principal Investigator: Eric Hollander, MD Montefiore Medical Center, Albert Einstein College of Medicine
  More Information

No publications provided

Responsible Party: Montefiore Medical Center Identifier: NCT00245635     History of Changes
Obsolete Identifiers: NCT00029471
Other Study ID Numbers: FD-R-002613-02, 7RO1FD002613-04
Study First Received: October 26, 2005
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Montefiore Medical Center:
Body Dysmorphic Disorder
BDD treatment
delusionality variant

Additional relevant MeSH terms:
Body Dysmorphic Disorders
Mental Disorders
Somatoform Disorders
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses processed this record on March 03, 2015