Status:
COMPLETED
A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder
Lead Sponsor:
Forest Laboratories
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse in major depressive disorder (MDD).
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Currently meet the DMS-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) criteria for Major Depressive Disorder (MDD)
- The participant must have an ongoing major depressive episode of at least 8 weeks and no more than 18 months
- The participant must have at least 3 lifetime episodes of MDD (including the current episode)
- Exclusion Criteria:
- 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
- Participants who are considered a suicide risk
- History of non-response to 2 or more antidepressants (after adequate treatment)
- Participants who have a history of meeting DMS-5 criteria for manic, hypomanic, or mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic disorder
- Panic disorder
Exclusion
Key Trial Info
Start Date :
November 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2016
Estimated Enrollment :
644 Patients enrolled
Trial Details
Trial ID
NCT02288325
Start Date
November 18 2014
End Date
September 16 2016
Last Update
October 29 2018
Active Locations (47)
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1
Forest Investigative Site 053
Birmingham, Alabama, United States, 35294
2
Forest Investigative Site 050
Dothan, Alabama, United States, 36303
3
Forest Investigative Site 039
Phoenix, Arizona, United States, 85032
4
Forest Investigative Site 048
Beverly Hills, California, United States, 90210