Abstracts
3427197
(#62) Long-Term Efficacy of Lumateperone 42 mg for the Treatment of Adults with Schizophrenia and Clinically Relevant Depressive Symptoms: A Post Hoc Analysis of a 1-Year Open-Label Study
Abstract: Background: Depressive symptoms are estimated to affect over half of adults with schizophrenia over their lifetime and are associated with increased rates of relapse and hospitalization.
Methods: This post hoc analysis of a 1-year, open-label, phase 3 safety study of lumateperone 42mg evaluated efficacy and safety outcomes in adults with stable schizophrenia and baseline clinically relevant depressive symptoms (Calgary Depression Scale for Schizophrenia [CDSS] score >6). Outcomes included change from baseline to day 368 in Positive and Negative Syndrome Scale (PANSS) total score, subscales, Marder factors, and Clinical Global Impression-Severity (CGI-S) and Personal and Social Performance (PSP) scores. Safety was assessed.
Results: Of 602 patients included in the safety analysis set, 48 met the criteria for clinically relevant depression. In this subgroup, lumateperone significantly reduced PANSS total score from baseline to day 368 (mean change=−12.65 (95% CI -20.4,−4.9); P=0.004). Significant improvements with lumateperone were observed in CGI-S (−0.59 [95% CI −1.1,−0.1]; P=0.020) and PSP scores (5.06 [95% CI 0.2,9.9]; P=0.041), PANSS Positive (−3.65 [95% CI −5.9,−1.4]; P=0.002), Negative (−1.59 [95% CI −3.2,0.0]; P=0.045), and General Psychopathology (−7.41 [95% CI −12.2,−2.7]; P=0.007) subscales, and Marder Positive (−2.82 [95% CI −5.3,−0.4]; P=0.013), Negative (−2.12 [95% CI −4.1,−0.2]; P=0.026), Disorganized Thought (−2.29 [95% CI −4.2,−0.4); P=0.023], and Anxiety/Depression factors (−3.88 [95% CI −5.7,−2.0]; P 0.001). No new safety signals were identified.
Conclusion: In patients with stable schizophrenia and baseline clinically relevant depressive symptoms, long-term treatment with lumateperone 42mg significantly improved a broad range of schizophrenia- and depression-related outcomes and was well tolerated.
Short Description: In a post hoc analysis of a 1-year, open-label, Phase 3 safety study in a patient subgroup with stable schizophrenia and baseline clinically relevant depressive symptoms, lumateperone 42 mg significantly reduced a broad range of schizophrenia- and depression-related symptoms and was well tolerated. Significant improvements from baseline to Day 368 were observed for CGI-S, PSP, PANSS Total score, PANSS Positive, Negative, and General Psychopathology subscales, and PANSS Marder Positive, Negative, Disorganized Thought, and Anxiety/Depression factors.
Name of Sponsoring Organization(s): Johnson & Johnson
Methods: This post hoc analysis of a 1-year, open-label, phase 3 safety study of lumateperone 42mg evaluated efficacy and safety outcomes in adults with stable schizophrenia and baseline clinically relevant depressive symptoms (Calgary Depression Scale for Schizophrenia [CDSS] score >6). Outcomes included change from baseline to day 368 in Positive and Negative Syndrome Scale (PANSS) total score, subscales, Marder factors, and Clinical Global Impression-Severity (CGI-S) and Personal and Social Performance (PSP) scores. Safety was assessed.
Results: Of 602 patients included in the safety analysis set, 48 met the criteria for clinically relevant depression. In this subgroup, lumateperone significantly reduced PANSS total score from baseline to day 368 (mean change=−12.65 (95% CI -20.4,−4.9); P=0.004). Significant improvements with lumateperone were observed in CGI-S (−0.59 [95% CI −1.1,−0.1]; P=0.020) and PSP scores (5.06 [95% CI 0.2,9.9]; P=0.041), PANSS Positive (−3.65 [95% CI −5.9,−1.4]; P=0.002), Negative (−1.59 [95% CI −3.2,0.0]; P=0.045), and General Psychopathology (−7.41 [95% CI −12.2,−2.7]; P=0.007) subscales, and Marder Positive (−2.82 [95% CI −5.3,−0.4]; P=0.013), Negative (−2.12 [95% CI −4.1,−0.2]; P=0.026), Disorganized Thought (−2.29 [95% CI −4.2,−0.4); P=0.023], and Anxiety/Depression factors (−3.88 [95% CI −5.7,−2.0]; P 0.001). No new safety signals were identified.
Conclusion: In patients with stable schizophrenia and baseline clinically relevant depressive symptoms, long-term treatment with lumateperone 42mg significantly improved a broad range of schizophrenia- and depression-related outcomes and was well tolerated.
Short Description: In a post hoc analysis of a 1-year, open-label, Phase 3 safety study in a patient subgroup with stable schizophrenia and baseline clinically relevant depressive symptoms, lumateperone 42 mg significantly reduced a broad range of schizophrenia- and depression-related symptoms and was well tolerated. Significant improvements from baseline to Day 368 were observed for CGI-S, PSP, PANSS Total score, PANSS Positive, Negative, and General Psychopathology subscales, and PANSS Marder Positive, Negative, Disorganized Thought, and Anxiety/Depression factors.
Name of Sponsoring Organization(s): Johnson & Johnson
