Poster
57
(#57) Lumateperone Treatment for Major Depressive Episodes with Mixed Features in Major Depressive Disorder and Bipolar I or Bipolar II Disorder: A Post Hoc Analysis of Anhedonia
Psych Congress 2025
Abstract: Background: Lumateperone is FDA-approved to treat schizophrenia and bipolar depression. In a randomized trial (Study 403; NCT04285515) lumateperone 42mg demonstrated efficacy and safety in patients with major depressive disorder (MDD) or bipolar depression with mixed features. This post hoc analysis evaluated efficacy of lumateperone 42mg on anhedonia-related symptoms.
Methods: Adults had DSM-5-diagnosed MDD or bipolar depression with mixed features and experienced a major depressive episode (Montgomery-Asberg Depression Rating Scale [MADRS] Total score≥24, Clinical Global Impression Scale-Severity score≥4). Patients received 6-weeks lumateperone 42mg or placebo. Anhedonia was evaluated in the combined and individual MDD and bipolar depression populations by change from baseline in MADRS anhedonia factor score and its individual MADRS item components (apparent sadness, reported sadness, concentration difficulties, lassitude, and inability to feel).
Results: Lumateperone significantly improved MADRS anhedonia factor score vs placebo from baseline to Day 43 in all 3 populations: combined MDD/bipolar depression (placebo, n=191; lumateperone, n=192; least squares mean difference vs placebo [LSMD]=−3.4; 95%CI −4.56 to −2.26; effect size [ES]=−0.63; P.0001), MDD (placebo, n=92; lumateperone, n=92; LSMD=−3.4; 95%CI −4.97 to −1.76; ES=−0.63; P.0001), and bipolar depression (placebo, n=99; lumateperone, n=100; LSMD=−3.3; 95%CI −4.89 to −1.67; ES=−0.61; P.0001). In the combined MDD/bipolar depression population, all MADRS items comprising the anhedonia factor score significantly improved with lumateperone vs placebo on Day 43 relative to baseline. Lumateperone was generally safe and well tolerated and consistent with prior studies.
Conclusion: Lumateperone 42mg improved anhedonia-related symptoms and was generally well tolerated in patients with MDD or bipolar depression with mixed features.
Short Description: This post hoc analysis of Study 403 (NCT04285515) assessed efficacy of lumateperone 42 mg in improving anhedonia in patients with major depressive disorder (MDD) or bipolar depression with mixed features. Lumateperone significantly improved the Montgomery-Asberg Depression Rating Scale anhedonia factor score and its individual item components from baseline to Day 43 vs placebo in patients with MDD or bipolar depression with mixed features. Overall, lumateperone 42 mg improved anhedonia-related symptoms and was generally well tolerated.
Name of Sponsoring Organization(s): Intra-Cellular Therapies, a Johnson & Johnson Company
Methods: Adults had DSM-5-diagnosed MDD or bipolar depression with mixed features and experienced a major depressive episode (Montgomery-Asberg Depression Rating Scale [MADRS] Total score≥24, Clinical Global Impression Scale-Severity score≥4). Patients received 6-weeks lumateperone 42mg or placebo. Anhedonia was evaluated in the combined and individual MDD and bipolar depression populations by change from baseline in MADRS anhedonia factor score and its individual MADRS item components (apparent sadness, reported sadness, concentration difficulties, lassitude, and inability to feel).
Results: Lumateperone significantly improved MADRS anhedonia factor score vs placebo from baseline to Day 43 in all 3 populations: combined MDD/bipolar depression (placebo, n=191; lumateperone, n=192; least squares mean difference vs placebo [LSMD]=−3.4; 95%CI −4.56 to −2.26; effect size [ES]=−0.63; P.0001), MDD (placebo, n=92; lumateperone, n=92; LSMD=−3.4; 95%CI −4.97 to −1.76; ES=−0.63; P.0001), and bipolar depression (placebo, n=99; lumateperone, n=100; LSMD=−3.3; 95%CI −4.89 to −1.67; ES=−0.61; P.0001). In the combined MDD/bipolar depression population, all MADRS items comprising the anhedonia factor score significantly improved with lumateperone vs placebo on Day 43 relative to baseline. Lumateperone was generally safe and well tolerated and consistent with prior studies.
Conclusion: Lumateperone 42mg improved anhedonia-related symptoms and was generally well tolerated in patients with MDD or bipolar depression with mixed features.
Short Description: This post hoc analysis of Study 403 (NCT04285515) assessed efficacy of lumateperone 42 mg in improving anhedonia in patients with major depressive disorder (MDD) or bipolar depression with mixed features. Lumateperone significantly improved the Montgomery-Asberg Depression Rating Scale anhedonia factor score and its individual item components from baseline to Day 43 vs placebo in patients with MDD or bipolar depression with mixed features. Overall, lumateperone 42 mg improved anhedonia-related symptoms and was generally well tolerated.
Name of Sponsoring Organization(s): Intra-Cellular Therapies, a Johnson & Johnson Company
