Intra-Cellular Therapies announced positive topline results from Study 403 evaluating lumateperone 42mg as monotherapy in the treatment of major depressive episodes in patients with major depressive disorder with mixed features and in patients with bipolar depression with mixed features. Lumateperone 42mg given once daily met the primary endpoint in the study by demonstrating a statistically significant and clinically meaningful reduction in the MADRS total score compared to placebo at Week 6. "Lumateperone 42mg was statistically significant on the primary endpoint of symptom reduction on the Montgomery Asberg Depression Rating Scale (MADRS) for each patient population "
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Read More on ITCI:
- ITCI Gains on Promising Results in Depression Treatment
- Intra-Cellular Therapies Announces Positive Topline Results from Study 403 Evaluating Lumateperone as Monotherapy in Patients with Major Depressive Disorder with Mixed Features and Bipolar Depression with Mixed Features
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