Fluoxetine in Pediatric Body Dysmorphic Disorder
Information source: Mount Sinai School of Medicine
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Body Dysmorphic Disorder
Intervention: Fluoxetine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Mount Sinai School of Medicine Official(s) and/or principal investigator(s):
Eric Hollander, MD, Principal Investigator, Affiliation: Mount Sinai School of Medicine
Overall contact:
Holly Hamilton, Phone: (212) 241-3116, Email: holly.hamilton@mssm.edu
Summary
This trial will study the effectiveness of the medication fluoxetine for children and
adolescents ages 10-16 with BDD who qualify.
Clinical Details
Official title: Fluoxetine in Pediatric Body Dysmorphic Disorder
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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 three sites.
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
between the ages of 10-16, and participation in this trial will last approximately 14 weeks.
Eligibility
Minimum age: 10 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- male or female children and adolescents 10-16 years of age with a diagnosis of BDD
Exclusion Criteria:
-
Locations and Contacts
Holly Hamilton, Phone: (212) 241-3116, Email: holly.hamilton@mssm.edu
Massachusetts General, Boston, Massachusetts, United States; Recruiting
Angela Fang, Phone: 617-643-4779
University of Cincinnati, Cincinnati, Ohio, United States; Recruiting
Judy Depew, Phone: 513-558-3991, Email: judy.depew@psychiatry.uc.edu
Butler Hospital, Providence, Rhode Island, United States; Recruiting
Christine Walters, Phone: 401-455-6466
Additional Information
Starting date: November 2004
Ending date: December 2008
Last updated: December 4, 2007
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