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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
644
Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.
Dose-matched placebo taken orally once daily.
Time to First Relapse During the Double-Blind Treatment Period (DBTP)
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.
Time frame: From the randomization date (Week 20) to the relapse date during the 26-week DBTP (up to Week 46)
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Forest Investigative Site 053
Birmingham, Alabama, United States
Forest Investigative Site 050
Dothan, Alabama, United States
Forest Investigative Site 039
Phoenix, Arizona, United States
Forest Investigative Site 048
Beverly Hills, California, United States
Forest Investigative Site 047
Chino, California, United States
Forest Investigative Site 028
Costa Mesa, California, United States
Forest Investigative Site 021
Encino, 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
...and 37 more locations