A study to assess the efficacy and safety of lumateperone in patients with Bipolar Mania

Prior treatment

• In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or - At Screening (Visit 1), the patient scores “yes” on Items 4 or 5 in the Suicidal Ideation section of the Columbia–Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening; or - At Screening (Visit 1), the patient has had 1 or more suicidal attempts within 2 years prior to Screening (Visit 1); or - At Baseline (Visit 2), the patient scores “yes” on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or o At Screening (Visit 1) or Baseline (Visit 2), scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or - Considered to be an imminent danger to himself/herself or others
• The patient has received electroconvulsive therapy (ECT), vagal nerve stimulation, or repetitive trans-cranial magnetic stimulation within the past 1 year

Other illness

• Has a current primary DSM-5 psychiatric diagnosis other than bipolar disorder. These include: - Schizophrenia, schizoaffective disorder, or other psychotic disorders; - Dementia or other cognitive disorders; - Intellectual disability; - Moderate or severe substance use disorder (excluding for nicotine)
• The patient has known hypersensitivity or intolerance to lumateperone, or to any of the excipients

Other

• Experiencing first manic episode

• Patient provides written informed consent.
• Male or female inpatient, between the ages of 18 and 75 years, inclusive
• Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision criteria for bipolar I disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT);and meets all of the following criteria: a. The start of the current manic or manic with mixed features episode is ≤ 4 weeks prior to Screening (Visit 1); b. 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 (Visit 1) and Baseline (Visit 2); c. Have at least moderate severity of illness based on CGI-S total score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2);
• Hospitalized voluntarily before Screening (Visit 1) or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not > 14 days before Screening (Visit 1). Hospital admission must be a result of the current manic episode