Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

Major Inclusion Criteria: * Male or female subjects of any race, ages 18-75 inclusive * Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM 5) criteria for Bipolar I or Bipolar II Disorder or MDD * The start of the current major depressive episode is at least 2 weeks but no more than 6 months prior to the Screening (Visit 1) * Has at least moderate severity of illness, as measured by a rater-administered MADRS total score ≥ 24 and corresponding to a CGI S score of ≥ 4 at Screening (Visit 1) and Baseline (Visit 2) * The patient meets the DSM-5 criteria for mixed-features specific to the Bipolar I or II diagnosis or MDD diagnosis * Current major depressive episode is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning * Able to provide written informed consent Major Exclusion Criteria: * Any female subject who is pregnant or breast-feeding * Any subject judged to be medically inappropriate for study participation * The patient has a significant risk for suicidal behavior * The patient presents with a lifetime history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or other cognitive disorder or significant brain trauma