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Add-on Lumateperone Eases MDD in Patients With Inadequate Antidepressant Response
Adjunctive treatment with the atypical antipsychotic lumateperone improved depressive symptoms and severity more than adjunctive placebo in patients with major depressive disorder (MDD) with inadequate response to previous antidepressant therapy, according to a poster presentation at Psych Congress.
The phase 3, double-blind multicenter trial included 480 patients with MDD who, despite at least 1 prior course of antidepressant therapy, had less than a 50% improvement on the Antidepressant Treatment Response Questionnaire. Patients also had Montgomery-Åsberg Depression Rating Scale (MADRS) total scores of 24 or more, Clinical Global Impression Scale-Severity (CGI-S) scores of 4 or more, and Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) scores of 14 or more.
The study randomly assigned 242 patients to lumateperone 42 mg and 238 patients to placebo in addition to their antidepressant therapy for 6 weeks. Patients were an average 46 years, 70% were women, and 95% were White. Some 89% completed treatment.
Patients treated with adjunctive lumateperone showed clinically meaningful improvement compared with patients treated with adjunctive placebo in MADRS total score (researchers reported a least squares mean difference [LSMD] of −4.5 vs placebo) and CGI-S score (LSMD of −0.5) on day 43, according to the poster. The corresponding effect sizes were −0. 56 for MADRS and −0.51 for CGI-S.
Adjunctive lumateperone was associated with clinically meaningful improvements in MADRS total score and CGI-S score compared with placebo on day 43. Least squares mean differences were −4.5 for MADRS total score (−0. 56 effect size) and −0.5 for CGI-S score (−0.51 effect size) with lumateperone vs placebo. Additionally, QIDS-SR-16 total scores significantly improved with adjunctive lumateperone compared with placebo, with a least squares mean difference of −2.2.
Consistent with prior studies, lumateperone was generally well-tolerated, with mostly mild-to-moderate adverse events.
“The results support lumateperone as a promising adjunctive therapy for patients with MDD who had inadequate antidepressant therapy response,” reported presenter John Edwards, MD, of Intra-Cellular Therapies Inc.
Intra-Cellular Therapies sponsored the poster.
Reference
Edwards J, et al. Adjunctive lumateperone in patients with major depressive disorder: results from an additional randomized, double-blind, phase 3 trial. Poster presented at Psych Congress; October 29 – November 2, 2024; Boston, Massachusetts.
