Status:
COMPLETED
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder
Lead Sponsor:
Forest Laboratories
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD).
Eligibility Criteria
Inclusion
- Men and women, 18-65 years old
- Currently meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (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 of child-bearing 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 :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT01254305
Start Date
April 1 2011
End Date
July 1 2012
Last Update
August 6 2014
Active Locations (20)
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1
Forest Investigative Site 010
Birmingham, Alabama, United States, 35216
2
Forest Investigative Site 002
Little Rock, Arkansas, United States, 72223
3
Forest Investigative Site 001
Cerritos, California, United States, 90703
4
Forest Investigative Site 014
Fort Myers, Florida, United States, 33912