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Psych Congress  

Sustained Improvement in Functional Health and Well-Being In MDD Patients Following Long-Term Treatment With Levomilnacipran ER

Authors  
Alix Bennett, PhD. Steven I. Blum, MBA. Stavros Tourkodimitris, MD. Carl Gommoll, Msc. Michael E. Thase, MD.
Sponsor  
Forest Research Institute

OBJECTIVES: 
Levomilnacipran is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI) approved for major depressive disorder (MDD) in adults. This analysis evaluated the long-term benefits of levomilnacipran ER on functional health and well-being of MDD patients using the SF-36v2 Health Survey.

METHODS: 
MDD patients who completed 1 of 3 placebo-controlled lead-in studies were eligible to participate in this 48-week open-label extension study (NCT01034267) of levomilnacipran ER 40-120 mg/d. Mean change from lead-in study baseline for 8 individual SF-36 health domain scores [Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE), Mental Health (MH)], and the Physical (PCS) and Mental (MCS) Component Summary scores were summarized (mean±SD) using Observed Cases (OC) at Week 48.

RESULTS: 
A total of 811 patients had baseline SF-36 scores; 378 patients (47%) completed 48 weeks of treatment. Improvements from baseline were noted for all individual health domains. Greatest improvement was seen in MH (22.19±13.62), followed by RE (20.87±14.32), SF (20.24±13.52), VT (18.51±12.76), RP (8.45±13.01), GH (8.01±9.49), BP (7.01±11.57) and PF (5.48±10.53). Significant improvement was noted for the MCS (26.53±15.42); PCS scores were in the "normal" range at baseline and showed minimal change (0.99±10.22). At Week 48, all scores were within 1.0 SD (10) of the US population norm (50), and all domains except for RE reached the "normal" range (47-53). 

CONCLUSIONS: 
Long-term treatment with levomilnacipran ER in patients with MDD resulted in sustained improvement in functional health and well-being as measured by the SF-36.

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