Fluoxetine in Pediatric Body Dysmorphic Disorder

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

Detailed Description
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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.

Official Title
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Fluoxetine in Pediatric Body Dysmorphic Disorder

Conditions
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Body Dysmorphic Disorder

Intervention / Treatment
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* Drug: Fluoxetine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoxetine<br>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<br>* Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.<br>* Other names: Prozac;|
| Placebo Comparator: Placebo<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Score on the BDD-Y-BOCS Scale | 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. | Baseline compared to the study endpoint (week 12) [two time points] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body Dysmorphic Disorder, BDD, BDD treatment, delusionality variant, OCD