Abstracts
3427194
(#61) Efficacy of Lumateperone 42 mg for the Treatment of Adults With Schizophrenia and Clinically Relevant Depressive Symptoms: Results of a Post Hoc Pooled Analysis
Abstract: Background: The efficacy and safety of lumateperone 42mg in adults with an acute exacerbation of schizophrenia were established in two 4-week, randomized, double-blind, placebo-controlled trials (NCT01499563 and NCT02282761). 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 pooled analysis examined the efficacy and safety of lumateperone 42mg in adults with schizophrenia and baseline clinically relevant depressive symptoms (Calgary Depression Scale for Schizophrenia [CDSS] score >6). Outcomes included change from baseline to day 28 in Positive and Negative Syndrome Scale (PANSS) total score, as well as subscales, Marder factors, and Clinical Global Impression-Severity score. Safety outcomes were also assessed.
Results: In the intent-to-treat subgroup with CDSS >6 at baseline (lumateperone, n=34; placebo, n=41), lumateperone significantly reduced PANSS total score from baseline to day 28 (least squares mean difference [LSMD]=−9.7 [95% CI −16.8, −2.7]; P=0.007) vs placebo. Significant improvements with lumateperone were also observed for CGI-S score (LSMD=−0.5 [95% CI −0.9, −0.1]; P=0.011), PANSS Positive (LSMD=−3.1 [95% CI −5.3, −0.8]; P=0.01), Negative (LSMD=−2.7 [95% CI −5.0, −0.4]; P=0.023), and General Psychopathology (LSMD=−4.0 [95% CI −7.7, −0.2]; P=0.037) subscales, and Marder Positive (LSMD=−3.6 [95% CI −6.2, −1.1]; P=0.006), and Disorganized Thought (LSMD=−2.2 [95% CI (−3.9, −0.6]; P=0.007) factors vs placebo. No new safety signals were identified.
Conclusion: In this subgroup of adults with schizophrenia and baseline depressive symptoms, lumateperone 42mg significantly reduced a broad range of schizophrenia-related symptoms and was well tolerated.
Short Description: In a post hoc pooled analysis of two 4-week randomized controlled trials in a patient subset with acute exacerbation of 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 28 were observed in PANSS Total score; PANSS Positive, Negative, and General Psychopathology subscales; and PANSS Marder Positive and Disorganized Thought factors vs placebo.
Name of Sponsoring Organization(s): Johnson & Johnson
Methods: This post hoc pooled analysis examined the efficacy and safety of lumateperone 42mg in adults with schizophrenia and baseline clinically relevant depressive symptoms (Calgary Depression Scale for Schizophrenia [CDSS] score >6). Outcomes included change from baseline to day 28 in Positive and Negative Syndrome Scale (PANSS) total score, as well as subscales, Marder factors, and Clinical Global Impression-Severity score. Safety outcomes were also assessed.
Results: In the intent-to-treat subgroup with CDSS >6 at baseline (lumateperone, n=34; placebo, n=41), lumateperone significantly reduced PANSS total score from baseline to day 28 (least squares mean difference [LSMD]=−9.7 [95% CI −16.8, −2.7]; P=0.007) vs placebo. Significant improvements with lumateperone were also observed for CGI-S score (LSMD=−0.5 [95% CI −0.9, −0.1]; P=0.011), PANSS Positive (LSMD=−3.1 [95% CI −5.3, −0.8]; P=0.01), Negative (LSMD=−2.7 [95% CI −5.0, −0.4]; P=0.023), and General Psychopathology (LSMD=−4.0 [95% CI −7.7, −0.2]; P=0.037) subscales, and Marder Positive (LSMD=−3.6 [95% CI −6.2, −1.1]; P=0.006), and Disorganized Thought (LSMD=−2.2 [95% CI (−3.9, −0.6]; P=0.007) factors vs placebo. No new safety signals were identified.
Conclusion: In this subgroup of adults with schizophrenia and baseline depressive symptoms, lumateperone 42mg significantly reduced a broad range of schizophrenia-related symptoms and was well tolerated.
Short Description: In a post hoc pooled analysis of two 4-week randomized controlled trials in a patient subset with acute exacerbation of 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 28 were observed in PANSS Total score; PANSS Positive, Negative, and General Psychopathology subscales; and PANSS Marder Positive and Disorganized Thought factors vs placebo.
Name of Sponsoring Organization(s): Johnson & Johnson
