Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder

Exclusion Criteria

• •History of psychiatric condition other than schizophrenia that, in the Investigator's opinion, may be detrimental to participation in the study;
• •Any suicidal ideation or wish to be dead within the past 6 months of Screening, any suicide attempt within the past 2 years prior to Screening, or any current concern for the patient's safety based on the Columbia-Suicide Severity Rating Scale (C-SSRS) (excluding self-injurious, non-suicidal behavior), and/or Investigator assessment that the patient is a safety risk to him/herself or others;
• •Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables;
• •Has a QT interval corrected for heart rate using Fridericia formula \> 450 msec in males or \> 470 msec in females, or evidence of clinically significant bundle branch blocks on ECG at Screening.