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Completed

NCT Number: NCT00245635

Fluoxetine in Pediatric Body Dysmorphic Disorder

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

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Key information

Conditions

Body Dysmorphic Disorder Body Dysmorphic Disorders Mental Disorders Somatoform Disorders

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoxetine

Drug

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

Drug

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Food and Drug Administration (FDA)

Registry information

Acronym: FDA BDD

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Oct 28, 2005
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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