Abstracts
3427198
(#28) Efficacy of Lumateperone 42 mg for the Treatment of Major Depressive Disorder: Analysis of Demographic and Clinical Subgroups in a Phase 3 Randomized Placebo-Controlled Trial
Abstract: Background: Lumateperone is an atypical antipsychotic indicated to treat schizophrenia and bipolar depression, and as adjunctive to antidepressant therapy (ADT) for major depressive disorder (MDD). This analysis of a positive Phase 3, randomized, double-blind, placebo-controlled study (NCT04985942) evaluated the efficacy of lumateperone 42mg+ADT in demographic and clinical subgroups of patients with MDD with inadequate ADT response.
Methods: Adults with DSM-5-defined MDD with inadequate response to 1-2 ADT in the current depressive episode, Montgomery-Asberg Depression Rating Scale (MADRS) Total score ≥24, Clinical Global Impression-Severity (CGI-S) score ≥4, and Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥14 were randomized 1:1 to 6-week, oral lumateperone 42mg+ADT or placebo+ADT. Efficacy was evaluated in the overall population and patient subgroups by demographics (age, sex, race, ethnicity, region) and baseline disease characteristics (MADRS Total score, ADT type, number of ADT failures in current episode, anxious distress).
Results: The modified intent-to-treat population comprised 481 patients (lumateperone+ADT, n=239; placebo+ADT, n=242). At Day 43, lumateperone+ADT significantly improved MADRS Total score (least squares mean difference vs placebo [LSMD]=−4.9; effect size [ES]=−0.61; P.0001), CGI-S score (LSMD=−0.7; ES=−0.67; P.0001), and QIDS-SR-16 Total score (LSMD=−2.4; P.0001) vs placebo+ADT. From baseline to Day 43, lumateperone+ADT significantly improved (P.05) MADRS Total score and CGI-S score across all demographic and disease characteristic subgroups vs placebo+ADT. QIDS-SR-16 Total score improvement (P.05) occurred in all subgroups at Day 43, except race (White, P.0001; non-White, P=.5011).
Conclusion: Lumateperone 42mg+ADT demonstrated robust efficacy over placebo+ADT across demographic and clinical subgroups of patients with MDD with inadequate ADT response
Short Description: In this analysis of a positive Phase 3, randomized, double-blind, placebo-controlled study (NCT04985942), lumateperone 42mg adjunctive to ADT significantly improved MADRS Total score, CGI-S score, and QIDS-SR-16 Total score across the majority of demographic subgroups (age, sex, race, ethnicity, region) and disease characteristics subgroups (MADRS Total score, ADT type, number of ADT failures, presence of anxious distress) at Day 43 vs placebo+ADT. These results demonstrate robust efficacy of lumateperone+ADT in subgroups of patients with MDD.
Name of Sponsoring Organization(s): Intra-Cellular Therapies, a Johnson & Johnson company
Methods: Adults with DSM-5-defined MDD with inadequate response to 1-2 ADT in the current depressive episode, Montgomery-Asberg Depression Rating Scale (MADRS) Total score ≥24, Clinical Global Impression-Severity (CGI-S) score ≥4, and Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥14 were randomized 1:1 to 6-week, oral lumateperone 42mg+ADT or placebo+ADT. Efficacy was evaluated in the overall population and patient subgroups by demographics (age, sex, race, ethnicity, region) and baseline disease characteristics (MADRS Total score, ADT type, number of ADT failures in current episode, anxious distress).
Results: The modified intent-to-treat population comprised 481 patients (lumateperone+ADT, n=239; placebo+ADT, n=242). At Day 43, lumateperone+ADT significantly improved MADRS Total score (least squares mean difference vs placebo [LSMD]=−4.9; effect size [ES]=−0.61; P.0001), CGI-S score (LSMD=−0.7; ES=−0.67; P.0001), and QIDS-SR-16 Total score (LSMD=−2.4; P.0001) vs placebo+ADT. From baseline to Day 43, lumateperone+ADT significantly improved (P.05) MADRS Total score and CGI-S score across all demographic and disease characteristic subgroups vs placebo+ADT. QIDS-SR-16 Total score improvement (P.05) occurred in all subgroups at Day 43, except race (White, P.0001; non-White, P=.5011).
Conclusion: Lumateperone 42mg+ADT demonstrated robust efficacy over placebo+ADT across demographic and clinical subgroups of patients with MDD with inadequate ADT response
Short Description: In this analysis of a positive Phase 3, randomized, double-blind, placebo-controlled study (NCT04985942), lumateperone 42mg adjunctive to ADT significantly improved MADRS Total score, CGI-S score, and QIDS-SR-16 Total score across the majority of demographic subgroups (age, sex, race, ethnicity, region) and disease characteristics subgroups (MADRS Total score, ADT type, number of ADT failures, presence of anxious distress) at Day 43 vs placebo+ADT. These results demonstrate robust efficacy of lumateperone+ADT in subgroups of patients with MDD.
Name of Sponsoring Organization(s): Intra-Cellular Therapies, a Johnson & Johnson company
