Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Treatment with lumateperone significantly reduced depressive symptoms in patients with major depressive disorder (MDD), according to results from a phase 3 study.
Study 501 was a randomized, double-blind, placebo-controlled study (ClinicalTrials.gov Identifier: NCT04985942) that evaluated the efficacy and safety of lumateperone as an adjunctive treatment to antidepressants in 485 patients with MDD. Study participants were randomly assigned 1:1 to receive lumateperone 42mg or placebo once daily. At baseline, Montgomery-Åsberg Depression Rating Scale (MADRS) total scores were 30.4 for the lumateperone group and 30.0 for the placebo group.
Findings showed treatment with lumateperone met the primary endpoint demonstrating a statistically significant and clinically meaningful reduction in MADRS total score at week 6 vs placebo (least squares [LS] mean reduction: 14.7 points vs 9.8 points, respectively; LS mean difference: -4.9 points; P <.0001; Cohen’s d effect size = 0.61).
Lumateperone was also associated with statistically significant improvements on the Clinical Global Impression Scale for Severity of Illness (CGI-S) at week 6 (P <.0001; Cohen’s d effect size =0.67) and in the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) scale (P <.0001) compared with placebo (both secondary endpoints).
As for safety, the most common adverse events reported were dry mouth (10.8%), fatigue (9.5%) and tremor (5.0%). These events were mostly mild to moderate in severity.
“In this phase 3 study, lumateperone demonstrated a robust effect as an adjunctive treatment to antidepressants in patients with MDD who had inadequate response to antidepressant therapy,” said Dr Suresh Durgam, Executive Vice President, Chief Medical Officer of Intra-Cellular Therapies. “This study contributes to the growing body of evidence of lumateperone’s efficacy and safety across mood disorders.”
Topline results from a second phase 3 study evaluating lumateperone as adjunctive therapy in patients with MDD (Study 502; ClinicalTrials.gov Identifier: NCT05061706) are expected late in the second quarter of 2024.
Lumateperone, an atypical antipsychotic, is currently marketed under the brand name Caplyta® for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder.
