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This phase 3, randomized, double-blind, placebo-controlled trial evaluated adjunctive lumateperone in adults aged 18–65 years with major depressive disorder and inadequate response to one or two antidepressant therapies. Participants received lumateperone 42 mg once daily plus antidepressant therapy (n=242) or placebo plus antidepressant therapy (n=238) for 6 weeks. At day 43, lumateperone significantly improved Montgomery–Åsberg Depression Rating Scale scores compared with placebo (least-squares mean difference [LSMD], −4.5; effect size, −0.56) and Clinical Global Impressions–Severity scores (LSMD, −0.5; effect size, −0.51). Patient-reported depressive symptoms also improved significantly (QIDS-SR-16 LSMD, −2.2; effect size, −0.45). The most frequent treatment-emergent adverse events included dizziness, somnolence, dry mouth, nausea, diarrhoea and fatigue; adverse-event-related discontinuation occurred in 12.4% versus 0.8%, respectively. Extrapyramidal symptoms were minimal, and weight gain and cardiometabolic abnormalities were similar between groups. The authors concluded that adjunctive lumateperone produced statistically significant and clinically meaningful improvement in depressive symptoms, with generally acceptable tolerability
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This phase 3, randomized, double-blind, placebo-controlled trial evaluated adjunctive lumateperone in adults aged 18–65 years with major depressive disorder and inadequate response to one or two antidepressant therapies. Participants received lumateperone 42 mg once daily plus antidepressant therapy (n=242) or placebo plus antidepressant therapy (n=238) for 6 weeks. At day 43, lumateperone significantly improved Montgomery–Åsberg Depression Rating Scale scores compared with placebo (least-squares mean difference [LSMD], −4.5; effect size, −0.56) and Clinical Global Impressions–Severity scores (LSMD, −0.5; effect size, −0.51). Patient-reported depressive symptoms also improved significantly (QIDS-SR-16 LSMD, −2.2; effect size, −0.45). The most frequent treatment-emergent adverse events included dizziness, somnolence, dry mouth, nausea, diarrhoea and fatigue; adverse-event-related discontinuation occurred in 12.4% versus 0.8%, respectively. Extrapyramidal symptoms were minimal, and weight gain and cardiometabolic abnormalities were similar between groups. The authors concluded that adjunctive lumateperone produced statistically significant and clinically meaningful improvement in depressive symptoms, with generally acceptable tolerability
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