Fluoxetine in Pediatric Body Dysmorphic Disorder - Full Text View

Sponsor:	Montefiore Medical Center
Collaborator:	Food and Drug Administration (FDA)
Information provided by (Responsible Party):	Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT00245635

Purpose

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

Condition	Intervention	Phase
Body Dysmorphic Disorder	Drug: Fluoxetine Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Fluoxetine in Pediatric Body Dysmorphic Disorder

Resource links provided by NLM:

Drug Information available for: Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:

Safety and Efficacy [ Time Frame: Each study week and end of study ] [ Designated as safety issue: Yes ]
To assess the efficacy and safety of fluoxetine in the treatment of pediatric body dysmorphic disorder (BDD) via a 13-week double-blind, placebo-controlled parallel group trial at two sites.

Estimated Enrollment:	37
Study Start Date:	November 2004
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: Fluoxetine Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score. Other Name: Prozac
Placebo Comparator: Placebo 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 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.

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.

Eligibility

Ages Eligible for Study:	up to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245635

Contacts

Contact: Casara J Ferretti, MS	718-696-3036	cferrett@montefiore.org
Contact: Steven Poskar, MD	718-653-4859 ext 223	sposkar@montefiore.org

Locations

United States, New York
Montefiore Medical Center, Albert Einstein College of Medicine	Recruiting
Bronx, New York, United States, 10467
Contact: Casara J Ferretti, MS 718-696-3036 cferrett@montefiore.org
Principal Investigator: Eric Hollander, MD
United States, Rhode Island
Rhode Island Hospital	Recruiting
Providence, Rhode Island, United States, 02903
Contact: William Menard 401-444-1644 wmenard@lifespan.org

Sponsors and Collaborators

Montefiore Medical Center

Food and Drug Administration (FDA)

Investigators

Principal Investigator:

Eric Hollander, MD

Montefiore Medical Center, Albert Einstein College of Medicine

More Information

No publications provided

Responsible Party:	Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT00245635 History of Changes
Obsolete Identifiers:	NCT00029471
Other Study ID Numbers:	FD-R-002613-02, 7RO1FD002613-04
Study First Received:	October 26, 2005
Last Updated:	October 5, 2011
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by Montefiore Medical Center:

Body Dysmorphic Disorder
BDD
BDD treatment
delusionality variant
OCD

Additional relevant MeSH terms:

Body Dysmorphic Disorders
Somatoform Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012