Status:
COMPLETED
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
Lead Sponsor:
Forest Laboratories
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder.
Eligibility Criteria
Inclusion
- Men and women, 18-80 years old
- Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
- The patient's current depressive episode must be at least 4 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:
- any manic or hypomanic episode
- schizophrenia or any other psychotic disorder
- obsessive-compulsive disorder
- Patients who are considered a suicide risk
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT00969150
Start Date
September 1 2009
Last Update
October 25 2013
Active Locations (25)
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1
Forest Investigative Site
Scottsdale, Arizona, United States, 85254
2
Forest Investigative Site
Encino, California, United States, 91316
3
Forest Investigative Site
Los Alamitos, California, United States, 90720
4
Forest Investigative Site
Oceanside, California, United States, 92056