Status:
COMPLETED
The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder
Lead Sponsor:
Forest Laboratories
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (S...
Eligibility Criteria
Inclusion
- Patient must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
- Patient's current depressive episode must be at least 12 weeks in duration
- Patient must have a parent or caregiver who must agree to accompany the patient to all clinic visits.
Exclusion
- Patients who currently meet DSM-IV criteria for:
- attention deficit-hyperactivity disorder
- obsessive-compulsive disorder
- posttraumatic stress disorder
- bipolar disorder
- pervasive developmental disorder
- mental retardation
- conduct disorder
- oppositional defiant disorder
- Patients who are considered a suicide risk (have active suicidal ideation), who have made a suicide attempt, or who have ever been hospitalized because of a suicide attempt.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT00107120
Start Date
March 1 2005
Last Update
April 6 2012
Active Locations (28)
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1
University of California at Davis, MIND Institute, Health Services
Sacramento, California, United States, 95817
2
UCSD Outpatient Psychiatry Services
San Diego, California, United States, 92103
3
PCSD - Feighner Research
San Diego, California, United States, 92111
4
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010