Status:
COMPLETED
Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients
Lead Sponsor:
Forest Laboratories
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active comparator in severely depressed patients
Detailed Description
Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed ...
Eligibility Criteria
Inclusion
- Patients must meet DSM-IV criteria for Major Depressive Disorder.
- Patients must have severe depression.
- MADRS greater than or equal to 30
Exclusion
- Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
- Patients who are considered a suicide risk.
- Patients who currently meet DSM-IV criteria for: a principal diagnosis for Axis I disorder other than MDD (comorbid GAD is allowed), bipolar disorder, schizophrenia or any psychotic disorder, obsessive-compulsive disorder, dysthymia.
- Patients with a family history of bipolar disorder, schizophrenia, or any psychotic disorder.
- Patients with history of any psychotic disorder or any psychotic feature.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT00384436
Start Date
October 1 2006
Last Update
January 7 2008
Active Locations (1)
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1
For information regarding investigative sites, contact Forest Professional Affairs
St Louis, Missouri, United States, 63045