Intra-Cellular Therapies announced several CAPLYTA data presentations at the 2023 Psych Congress held September 6 – 10, 2023 in Nashville. Poster 94: “Lumateperone Treatment for Major Depressive Episodes with Mixed Features in Major Depressive Disorder and Bipolar I or Bipolar II Disorder” In this study, lumateperone 42mg was statistically significant on the primary endpoint of symptom reduction on the Montgomery Asberg Depression Rating Scale for the combined mixed features patient population of MDD and bipolar depression and the individual patient populations of MDD with mixed features and bipolar depression with mixed features. Lumateperone 42mg also met the key secondary endpoint by demonstrating a statistically significant and clinically meaningful reduction in the Clinician’s Global Impression scale or CGI compared to placebo at Week 6 in these three populations. Lumateperone was generally safe and well tolerated, with a side effect profile consistent with prior lumateperone trials. The most common adverse events in the study were somnolence, dizziness and nausea. There were no notable changes in weight, body mass index, or waist circumference and no clinically relevant changes in metabolic parameters.
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