Fluoxetine in Pediatric Body Dysmorphic Disorder (FDA BDD)

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Body Dysmorphic Disorder

Treatments: Drug: Placebo; Drug: Fluoxetine

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00245635

7R01FD002613-04

09-10-302

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups, including a placebo group

Fluoxetine

Experimental group

Description:

Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.

Treatment:

Drug: Fluoxetine

Placebo

Placebo Comparator group

Description:

Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.

Treatment:

Drug: Placebo