A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

Key Inclusion Criteria:

• Male or female participants between 18 to 65 years of age (inclusive) at the time ofconsent.

• Participant has an identified reliable informant (eg, caregiver, relative, friend,case worker, residential treatment staff).

• Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening

1. The participant requires hospitalization for this acute exacerbation or relapseof symptoms.

2. If already an inpatient at screening, has been hospitalized for less than 2weeks for the current exacerbation at the time of screening.

• Participants who are experiencing an acute exacerbation of psychotic symptoms andmarked deterioration of usual function as demonstrated by meeting ALL of thefollowing criteria at the screening and baseline visits:

1. Participant must have a PANSS total score ≥ 80AND

2. Participant must have a CGI-S score ≥ 4.

• Participants who have received previous outpatient antipsychotic treatment at anadequate dose (minimal recommended dose for the treatment of schizophrenia accordingto the manufacturer labeling) for an adequate duration (at least 6 weeks) and whoshowed a previous good response.

Key Exclusion Criteria:

• Sexually active participants or persons of childbearing potential who do not agreeto practice 2 different clinical trial sponsor approved methods of birth control orremain abstinent during the course of the trial and for 30 days after the last doseof study drug.

• Participant has a current DSM-5 diagnosis or presence of symptoms consistent with aDSM-5 diagnosis other than schizophrenia.

• Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.

• Participant has previously received SEP-363856 or was previously enrolled in aSEP-363856 clinical study