Status:
COMPLETED
Escitalopram in Adult Patients With Major Depressive Disorder
Lead Sponsor:
Forest Laboratories
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram in adult patients (18 to 65 years of age) with moderate to severe depression. Patients completing the stud...
Eligibility Criteria
Inclusion
- Patients must meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder.
- The patient's current depressive episode must be at least 8 weeks in duration.
Exclusion
- Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.
- Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
- Patients who are considered a suicide risk
- Patients with a history of seizures (including seizure disorder), stroke, significant head injury, central nervous system tumors, or any other condition that predisposes patients to a risk for seizure.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
877 Patients enrolled
Trial Details
Trial ID
NCT00668525
Start Date
April 1 2008
Last Update
May 11 2010
Active Locations (45)
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1
Forest Investigative Site
Phoenix, Arizona, United States, 85016
2
Forest Investigative Site
Arcadia, California, United States, 91007
3
Forest Investigative Site
Encino, California, United States, 91316
4
Forest Investigative Site
Garden Grove, California, United States, 92845