Status:
COMPLETED
Fluoxetine in Pediatric Body Dysmorphic Disorder
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Food and Drug Administration (FDA)
Conditions:
Body Dysmorphic Disorder
Eligibility:
All Genders
Up to 16 years
Phase:
PHASE4
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 inhibi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00245635
Start Date
November 1 2004
End Date
April 1 2012
Last Update
April 27 2018
Active Locations (2)
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1
Montefiore Medical Center, Albert Einstein College of Medicine
The Bronx, New York, United States, 10467
2
Rhode Island Hospital
Providence, Rhode Island, United States, 02903