Fluoxetine in Pediatric Body Dysmorphic Disorder
Overview
- Phase
- Phase 4
- Intervention
- Fluoxetine
- Conditions
- Body Dysmorphic Disorder
- Sponsor
- Montefiore Medical Center
- Enrollment
- 43
- Locations
- 2
- Primary Endpoint
- Change in Total Score on the BDD-Y-BOCS Scale
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.
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.
Investigators
Eric Hollander
Prof. Psychiatry & Behavioral Sciences
Montefiore Medical Center
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Fluoxetine
Placebo
Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.
Intervention: Placebo
Outcomes
Primary Outcomes
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.