A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase

Inclusion Criteria

• •1. Must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities. If the subject is considered a minor according to local regulations at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject.
• •2. Male or female between 18 to 65 years of age (inclusive) at the time of consent.
• •3. Must meet DSM 5 criteria for schizophrenia as established by clinical interview at Screening
• •4. Must have a CGI S score ≥ 4 (moderately ill) at Screening and Baseline.
• •5. Must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 (moderate) on 2 or more of the following PANSS items: delusions (P1), conceptual disorganization (P2), hallucinations (P3), and unusual thought content (G9) at Screening and Baseline.
• •6. Must have an acute exacerbation of psychotic symptoms (no longer than 2 months prior to providing informed consent for this study). The acute exacerbation should include:
• •a. Marked deterioration of functioning in one or more areas, such as occupational, social, or personal care or hygiene.
• •7. In the opinion of the Investigator, subjects must be generally healthy based on Screening medical history, physical examination (PE), vital signs, ECG, and clinical laboratory values (hematology, chemistry, and urinalysis).