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Fluoxetine in Pediatric Body Dysmorphic Disorder (FDA BDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00245635
Recruitment Status : Completed
First Posted : October 28, 2005
Results First Posted : June 29, 2015
Last Update Posted : April 27, 2018
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Eric Hollander, Montefiore Medical Center

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

Condition or disease Intervention/treatment Phase
Body Dysmorphic Disorder Drug: Fluoxetine Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fluoxetine in Pediatric Body Dysmorphic Disorder
Study Start Date : November 2004
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

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 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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00245635

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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)
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Principal Investigator: Eric Hollander, MD Montefiore Medical Center/Albert Einstein College of Medicine
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Responsible Party: Eric Hollander, Prof. Psychiatry & Behavioral Sciences, Montefiore Medical Center Identifier: NCT00245635    
Obsolete Identifiers: NCT00029471
Other Study ID Numbers: 09-10-302
7R01FD002613-04 ( U.S. FDA Grant/Contract )
First Posted: October 28, 2005    Key Record Dates
Results First Posted: June 29, 2015
Last Update Posted: April 27, 2018
Last Verified: March 2018

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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
Keywords provided by Eric Hollander, Montefiore Medical Center:
Body Dysmorphic Disorder
BDD treatment
delusionality variant
Additional relevant MeSH terms:
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Body Dysmorphic Disorders
Pathologic Processes
Somatoform Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors