Objective: To evaluate categorical improvements in functional impairment associated with major depressive disorder (MDD) in adult patients treated with levomilnacipran extended-release (ER).
Methods: Data were pooled from 5 Phase II/III trials of levomilnacipran ER 40-120 mg/day vs placebo. Proportions of patients shifting from moderate-high baseline impairment (score ≥4) to mild-no impairment (score ≤3) at EOT were assessed for all SDS subscores (representing work, social life, and family/home domains). Shifts from marked-high baseline impairment (score ≥7) to moderate-no (score ≤6) or mild-no impairment (score ≤3) were also assessed.
Results: Across SDS subscales, more levomilnacipran ER vs placebo patients achieved categorical improvement. On the Work subscore, more levomilnacipran ER vs placebo patients improved from moderate-high baseline impairment to mild-no impairment (55% vs 40%, odds ratio [OR]=1.96, P<.0001); more levomilnacipran ER vs placebo patients with marked-high baseline impairment had moderate-no (73% vs 64%, OR=1.81, P<.0001) or mild-no (47% vs 33%, OR=1.9, P<.0001) impairment at EOT. On the Social subscore, more levomilnacipran ER vs placebo patients improved from moderate-high to mild-no impairment (48% vs 37%, OR=1.73, P<.0001), and from marked-high to moderate-no (68% vs 59%, OR=1.61, P<.0001) or mild-no (42% vs 29%, OR=1.9, P<.0001) impairment. On the Family/Home subscore, more levomilnacipran ER patients than placebo shifted from moderate-high to mild-no impairment (51% vs 39%, OR=1.72, P<.0001), and from marked-high to moderate-no (73% vs 65%, OR=1.47, P=.0027) or mild-no (45% vs 34%, OR=1.6, P=0.0002) impairment.
Conclusion: In this study, more MDD patients treated with levomilnacipran ER than placebo experienced categorical improvements across SDS functional domains.