Fluoxetine in Pediatric Body Dysmorphic Disorder

Official Title: “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.

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.

Primary Measures

• Safety and Efficacy
  • Time Frame: Each study week and end of study
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Montefiore Medical Center Other

Overall Clinical Trial Officials and Contacts

Eric Hollander, MD Principal Investigator Montefiore Medical Center, Albert Einstein College of Medicine  

Overall Contact: Casara J Ferretti, MS 718-696-3036 cferrett@montefiore.org

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00245635

Study ID Number: FD-R-002613-02

ClinicalTrials.gov Identifier: NCT00245635

Health Authority: United States: Institutional Review Board