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 morethan 6 months prior to the Screening (Visit 1)

• Has at least moderate severity of illness, as measured by a rater-administered MADRStotal 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 orII diagnosis or MDD diagnosis

• Current major depressive episode is causing clinically significant distress orimpairment 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, orelectroencephalogram with clinically significant abnormalities, delirium, dementia,amnestic, or other cognitive disorder or significant brain trauma