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Psych Congress  

Relapse Prevention With Levomilnacipran ER in Adults With Major Depressive Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Suresh Durgam, MD; Changzheng Chen, PhD; Raffaele Migliore, MA; Chandran Prakash, MD, MPH; Michael Thase, MD; Rocsanna Namdar, PharmD

This poster was presented at the 30th annual  Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.

Introduction: Levomilnacipran extended-release (LVM-ER) is a serotonin and norepinephrine reuptake inhibitor approved for the treatment of major depressive disorder (MDD) in adults. LVM-ER has been evaluated in 5 randomized, double-blind, placebo-controlled trials and 1 long-term, open-label study. This withdrawal study was designed to evaluate LVM-ER in the prevention of relapse in patients with MDD.

Methods: Patients received 20 weeks of open-label treatment with LVM-ER 40, 80, or 120 mg/d (8 weeks flexible dosing; 12 weeks stable dosing). Patients with a Montgomery-Ѓsberg Depression Rating Scale (MADRS) total score _12 from Weeks 8 to 20 of the open-label period were eligible to enter the 26-week randomized, double-blind, placebo-controlled withdrawal period. Patients were randomized to LVM-ER (same dosage) or placebo. The primary efficacy endpoint was time to first relapse, defined as MADRS total score _18 or insufficient therapeutic response. Safety assessments included adverse event (AE) reporting.

Results: In the double-blind intent-to-treat population (placebo=159; LVM-ER=165), LVM-ER-treated patients had a significantly longer time to relapse (P<.05) and lower risk of relapse than patients switched to placebo (hazard ratio, 0.56; 95% CI, 0.33-0.92). Crude relapse rates were 14.5% (LVM-ER) and 24.5% (placebo). Per Kaplan-Meier estimates, approximately 25% of placebo-treated patients relapsed by Day 168. AE summary for the double-blind period was as follows (LVM-ER, placebo): treatment-emergent AEs (58.8%, 56.0%); discontinuation due to AEs (3.0%, 1.3%); serious AEs (1.2%, 0.6%).

Conclusion: Among patients who responded to acute phase therapy with LVM-ER (40-120 mg/d), continuation phase therapy was both well-tolerated and significantly reduced the risk of relapse.

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