Comparative Effectiveness of Lumateperone Versus Olanzapine Fluoxetine Combination Therapy in Treating Bipolar Depression with Moderate to Severe Depressive Episode A Randomized Controlled Trial

The primary purpose of this study is to compare how well lumateperone works compared to the olanzapine–fluoxetine combination in treating adults with bipolar disorder who are currently experiencing a moderate to severe depressive episode. The study aims to assess improvement in depressive symptoms, overall clinical response, and how well patients tolerate and adhere to each treatment over an 8-week period.

The study hypothesizes that lumateperone will be as effective as, or more effective than, the olanzapine–fluoxetine combination in reducing depressive symptoms in bipolar depression, with better tolerability and fewer treatment-related side effects.