A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder
- Conditions
- Depressive Disorder, Major
- Interventions
- Drug: Placebo
- Registration Number
- NCT02288325
- Lead Sponsor
- Forest Laboratories
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 644
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double-Blind FETZIMA® Levomilnacipran ER FETZIMA® (levomilnacipran ER) taken orally at fixed dose of 40, 80 or 120 mg once daily for 26 weeks during double-blind treatment period. Open-Label FETZIMA® Levomilnacipran ER FETZIMA® (levomilnacipran extended release \[ER\]) taken orally during flexible dose titration up to 40, 80 or 120 mg once daily in 8-week run-in period followed by fixed dose of 40, 80 or 120 mg once daily in 12-week stabilization period. Double-Blind Placebo Placebo Dose-matched placebo taken orally once daily for 26 weeks during double-blind treatment period.
- Primary Outcome Measures
Name Time Method Time to First Relapse During the Double-Blind Treatment Period (DBTP) From the randomization date (Week 20) to the relapse date during the 26-week DBTP (up to Week 46) Time to relapse for the median was measured in days from randomization date at the start of the DBTP to relapse date during DBTP. Relapse was defined as meeting any 1 or more of the following criteria: 1) Insufficient therapeutic response at any one visit, including a \>/= 2 increase in Clinical Global Impressions-Severity (CGI-S) score (range 1 to 7) compared with that obtained at randomization, or risk of suicide as determined by the investigator, or need for hospitalization due to worsening of depression as determined by the investigator, or need for alternative treatment of depressive symptoms as determined by the Investigator; 2) Montgomery-Asberg Depression Rating Scale (MADRS) total score \>/= 18 (range 0 to 60) at 2 consecutive visits (second visit within 7 to 14 days after the first visit at which the MADRS total score was ≥ 18). Participant was considered censored at the last visit during DBTP if participant did not meet the relapse criteria during DBTP.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
Forest Investigative Site 021
🇺🇸Encino, California, United States
Forest Investigative Site 023
🇺🇸Bradenton, Florida, United States
Forest Investigative Site 050
🇺🇸Dothan, Alabama, United States
Forest Investigative Site 051
🇺🇸Watertown, Massachusetts, United States
Forest Investigative Site 018
🇺🇸Fort Myers, Florida, United States
Forest Investigative Site 037
🇺🇸Sherman Oaks, California, United States
Forest Investigative Site 048
🇺🇸Beverly Hills, California, United States
Forest Investigative Site 043
🇺🇸Simi Valley, California, United States
Forest Investigative Site 047
🇺🇸Chino, California, United States
Forest Investigative Site 019
🇺🇸Schaumburg, Illinois, United States
Forest Investigative Site 031
🇺🇸Brooklyn, New York, United States
Forest Investigative Site 009
🇺🇸Orlando, Florida, United States
Forest Investigative Site 053
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 054
🇺🇸Dallas, Texas, United States
Forest Investigative Site 039
🇺🇸Phoenix, Arizona, United States
Forest Investigative Site 040
🇺🇸Cromwell, Connecticut, United States
Forest Investigative Site 059
🇺🇸Houston, Texas, United States
Forest Investigative Site 003
🇺🇸New York, New York, United States
Forest Investigative Site 028
🇺🇸Costa Mesa, California, United States
Forest Investigative Site 052
🇺🇸Lemon Grove, California, United States
Forest Investigative Site 042
🇺🇸Oceanside, California, United States
Forest Investigative Site 016
🇺🇸Sherman Oaks, California, United States
Forest Investigative Site 038
🇺🇸Norwich, Connecticut, United States
Forest Investigative Site 008
🇺🇸Jacksonville Beach, Florida, United States
Forest Investigative Site 057
🇺🇸Kissimmee, Florida, United States
Forest Investigative Site 045
🇺🇸West Palm Beach, Florida, United States
Forest Investigative Site 020
🇺🇸Methuen, Massachusetts, United States
Forest Investigative Site 001
🇺🇸Jacksonville, Florida, United States
Forest Investigative Site 034
🇺🇸Alpharetta, Georgia, United States
Forest Investigative Site 049
🇺🇸Smyrna, Georgia, United States
Forest Investigative Site 044
🇺🇸Cherry Hill, New Jersey, United States
Forest Investigative Site 036
🇺🇸Cedarhurst, New York, United States
Forest Investigative Site 013
🇺🇸Mount Kisco, New York, United States
Forest Investigative Site 055
🇺🇸Rochester, New York, United States
Forest Investigative Site 058
🇺🇸Charlotte, North Carolina, United States
Forest Investigative Site 005
🇺🇸New York, New York, United States
Forest Investigative Site 035
🇺🇸Tulsa, Oklahoma, United States
Forest Investigative Site 011
🇺🇸Dayton, Ohio, United States
Forest Investigative Site 046
🇺🇸Portland, Oregon, United States
Forest Investigative Site 012
🇺🇸Media, Pennsylvania, United States
Forest Investigative Site 041
🇺🇸Salem, Oregon, United States
Forest Investigative Site 033
🇺🇸Memphis, Tennessee, United States
Forest Investigative Site 030
🇺🇸Memphis, Tennessee, United States
Forest Investigative Site 014
🇺🇸Murray, Utah, United States
Forest Investigative Site 056
🇺🇸Roanoke, Virginia, United States
Forest Investigative Site 010
🇺🇸Charlottesville, Virginia, United States
Forest Investigative Site 026
🇺🇸Brown Deer, Wisconsin, United States