Limitations of the study include the exclusion of patients with treatment-resistant illness, imminent suicidal risk, rapid cycling, or serious comorbid psychiatric or medical illnesses, which may limit the generalizability of the findings. This study only assessed lumateperone at 42 mg/day, so dose-response characteristics cannot be established, and it did not include an active treatment arm, so comparisons with other therapies are historical. Lastly, the safety data in this study are for short-term exposure; additional studies are needed to examine long-term safety in patients with bipolar disorder. Of note, lumateperone had a favorable safety and tolerability profile in a 1-year study in patients with stable schizophrenia