Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania

Inclusion Criteria:

1. Able to provide written informed consent before the initiation of any study specificprocedures;

2. Male or female inpatient, between the ages of 18 and 75 years, inclusive;

3. Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5)criteria for bipolar I disorder with a current episode of mania or mania with mixedfeatures with or without psychotic symptoms, as confirmed by a trained andSponsor-approved rater using the modified Structured Clinical Interview for DSM-5,Clinical Trials Version (SCID-5-CT);

4. YMRS total score ≥ 20 and a score of at least 4 on two of the following YMRS items:irritability, speech, content, and disruptive/aggressive behavior at Screening andBaseline;

5. Hospitalized voluntarily before Screening or admitted to inpatient unit at Visit 1with a primary diagnosis of mania but not > 14 days before Screening. Hospitaladmission must be a result of the current manic episode.

Exclusion Criteria:

1. Has a current primary DSM 5 psychiatric diagnosis other than bipolar disorder. Theseinclude:

2. Schizophrenia, schizoaffective disorder, or other psychotic disorders;

3. Dementia or other cognitive disorders;

4. Intellectual disability;

5. Moderate or severe substance use disorder (excluding for nicotine);

6. Experiencing first manic episode;

7. In the opinion of the Investigator, the patient has a significant risk for suicidalbehavior during the course of his/her participation in the study or

8. At Screening, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideationsection of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 monthsprior to Screening; or

9. At Screening, the patient has had 1 or more suicidal attempts within 2 yearsprior to Screening; or

10. At Baseline, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideationsection of the C-SSRS since the Screening Visit; or

11. At Screening or Baseline, scores ≥ 4 on Item 10 (suicidal thoughts) on therater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or

12. Considered to be an imminent danger to himself/herself or others.