Fluoxetine in Pediatric Body Dysmorphic Disorder

NCT00245635 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 09-10-3027R01FD002613-04
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Body Dysmorphic Disorder

Keywords

Body Dysmorphic Disorder; BDD; BDD treatment; delusionality variant; OCD

Outcome Measures

Primary Outcomes (1)

• 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]

Study Arms (2)

Fluoxetine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Fluoxetine DRUG

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

Also known as: Prozac

Fluoxetine

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (2)

Montefiore Medical Center, Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Body Dysmorphic Disorders

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Eric Hollander, MD
• Organization: Montefiore Medical Center, Albert Einstein College of Medicine

eholland@montefiore.org

7189204287

Study Officials

• Eric Hollander, MD

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Psychiatry & Behavioral Sciences

Study Record Dates

• First Submitted: October 26, 2005
• First Posted: October 28, 2005
• Study Start: November 1, 2004
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 27, 2018
• Results First Posted: June 29, 2015

Record last verified: 2018-03

Locations

US (2)