Levomilnacipran and vortioxetine: Review of new pharmacotherapies for major depressive disorder

Table 3 Randomized controlled trials of levomilnacipran for major depressive disorder[3,5,7-11]

Ref.	n	Duration	Key inclusion criteria	Doses	Primary outcome
Montgomery et al[7] Phase II	563	10 wk	Age 18-70 yr HAMD-17 > 22	Levomilnacipran 75-100 mg/d Placebo	Positive Change from baseline in MADRS Placebo: -14.5 Levomilnacipran: -18.7 (P < 0.001)
Greenberg[5] Phase III	362	11 wk	Age 18-80 yr Clinician-rated MADRS ≥ 30 Self-rated MADRS ≥ 26	Levomilnacipran 40-120 mg/d Placebo	Negative Change from baseline in MADRS Placebo: -14.2 Levomilnacipran: -15.7 (P = 0.249)
Asnis et al[8] Phase III	724	11 wk	Age 18-65 yr MADRS ≥ 30	Levomilnacipran 40 mg/d Levomilnacipran 80 mg/d Levomilnacipran 120 mg/d Placebo	Positive Change from baseline in MADRS Placebo: -11.6 40 mg: -14.8 (P < 0.05) 80 mg: -15.6 (P < 0.01) 120 mg: -16.5 (P < 0.001)
Bakish et al[9] Phase III	568	10 wk	Age 18-75 yr MADRS ≥ 26	Levomilnacipran 40 mg/d Levomilnacipran 80 mg/d Placebo	Positive Change from baseline in MADRS Placebo: -11.3 40 mg: -14.6 (P < 0.003) 80 mg: -14.4 (P < 0.004)
Sambunaris et al[10] Phase III	442	11 wk	Age 18-80 yr Clinician-rated MADRS ≥ 30 Self-rated MADRS ≥ 26	Levomilnacipran 40-120 mg/d Placebo	Positive Change from baseline in MADRS Placebo: -12.2 Levomilnacipran: -15.3 (P < 0.01)
Shiovitz et al[11] Phase III	734	24 wk	Age 18-65 yr MADRS ≥ 22	Levomilnacipran 40 mg/d Levomilnacipran 80 mg/d Levomilnacipran 120 mg/d Placebo	Failed Percent of patient relapse Placebo: 13.91% Levomilnacipran: 20.54% (P = 0.1651)

HAMD: Hamilton Rating Scale for Depression; MADRS: Montgomery-Asberg Depression Rating Scale.