Positive Results for Lumateperone in Patients With Mixed Features in Major Depressive Disorder, Bipolar Depression


New results for a study evaluating lumateperone.

study results


Recent results from study 403 showed that lumateperone (Caplyta) 42 mg monotherapy helped significantly reduce the severity of depressive symptoms in patients with mixed features in major depressive disorder (MDD) and in patients with mixed features in bipolar depression.

“In this study, lumateperone demonstrated a robust effect in both patients with MDD with mixed features and patients with bipolar depression with mixed features. This is particularly significant considering these patients suffer from greater symptom severity, increased recurrence of mood episodes, higher comorbidity, and increased risk of suicide,” said Stephen Stahl MD, PhD, DSc, clinical professor of psychiatry and neuroscience at the University of California Riverside. “Given the lack of available therapies for these patient populations, there is a tremendous need for treatment options.”

In the study, 383 participants were randomized to lumateperone or placebo, with similar distribution between the 2 conditions. The primary endpoint was change versus placebo on the Montgomery Asberg Depression Rating Scale (MADRS) total score at week 6. Lumateperone led to reductions of 5.9 points for MDD with mixed features and 5.7 points for bipolar depression with mixed features, compared to placebo.

Adverse events were mostly mild-to-moderate, with the most commonly reported being somnolence, dizziness, and nausea. Treatment-emergent adverse events occurred at a rate of 52.5% in the lumateperone arm versus 36.5% for placebo, while discontinuation rates due to treatment-emergent adverse events were 4.2% and 2.1%, respectively.

“We are very pleased with the results of this highly successful trial in these difficult to treat patient populations with mixed features in MDD and mixed features in bipolar depression,” said Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies. “This study provides proof of concept in these patient populations and further validates lumateperone’s broad potential in mood disorders. We look forward to discussing these results with the FDA and determining next steps for the program.”


1. 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. News release. March 28, 2023. Accessed March 29, 2023. https://ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-announces-positive-topline-results-0

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