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Fluoxetine in Pediatric Body Dysmorphic Disorder (FDA BDD)

Primary Purpose

Body Dysmorphic Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Placebo
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Dysmorphic Disorder focused on measuring Body Dysmorphic Disorder, BDD, BDD treatment, delusionality variant, OCD

Eligibility Criteria

undefined - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Montefiore Medical Center, Albert Einstein College of Medicine
  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fluoxetine

Placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 26, 2005
Last Updated
March 30, 2018
Sponsor
Montefiore Medical Center
Collaborators
Food and Drug Administration (FDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00245635
Brief Title
Fluoxetine in Pediatric Body Dysmorphic Disorder
Acronym
FDA BDD
Official Title
Fluoxetine in Pediatric Body Dysmorphic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
Food and Drug Administration (FDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Dysmorphic Disorder
Keywords
Body Dysmorphic Disorder, BDD, BDD treatment, delusionality variant, OCD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoxetine
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Change in Total Score on the BDD-Y-BOCS Scale
Description
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.
Time Frame
Baseline compared to the study endpoint (week 12) [two time points]

10. Eligibility

Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Hollander, MD
Organizational Affiliation
Montefiore Medical Center/Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center, Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

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Fluoxetine in Pediatric Body Dysmorphic Disorder

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