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Sponsors and Collaborators: |
Mount Sinai School of Medicine Food and Drug Administration (FDA) |
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Information provided by: | Mount Sinai School of Medicine |
ClinicalTrials.gov Identifier: | NCT00245635 |
This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 10-16 with BDD who qualify.
Condition | Intervention | Phase |
---|---|---|
Body Dysmorphic Disorder |
Drug: Fluoxetine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Fluoxetine in Pediatric Body Dysmorphic Disorder |
Estimated Enrollment: | 37 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | December 2008 |
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.
Ages Eligible for Study: | 10 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
-
Contact: Holly Hamilton | (212) 241-3116 | holly.hamilton@mssm.edu |
United States, Massachusetts | |
Massachusetts General | Recruiting |
Boston, Massachusetts, United States | |
Contact: Angela Fang 617-643-4779 | |
United States, Ohio | |
University of Cincinnati | Recruiting |
Cincinnati, Ohio, United States | |
Contact: Judy Depew 513-558-3991 judy.depew@psychiatry.uc.edu | |
United States, Rhode Island | |
Butler Hospital | Recruiting |
Providence, Rhode Island, United States | |
Contact: Christine Walters 401-455-6466 |
Principal Investigator: | Eric Hollander, MD | Mount Sinai School of Medicine |
Study ID Numbers: | GCO#02-1020, FD-R-002337 |
Study First Received: | October 26, 2005 |
Last Updated: | December 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00245635 |
Health Authority: | United States: Institutional Review Board |
Body Dsymorphic Disorder BDD BDD treatment |
Fluoxetine Hypochondriasis Mental Disorders Somatoform Disorders Serotonin |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors |
Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |