['bipolar depression']
['iti-007 (lumateperone)', 'placebo']

        Major Inclusion Criteria:

          -  male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis
             of Bipolar I or Bipolar II disorder

          -  experiencing a current major depressive episode

        Major Exclusion Criteria:

          -  any subject unable to provide informed consent

          -  any female subject who is pregnant or breast-feeding

          -  any subject judged to be medically inappropriate for study participation
      