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

Inclusion Criteria

• •Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.
• •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 relapse of symptoms.
• •2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.
• •Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:
• •1. Participant must have a PANSS total score ≥ 80
• •AND
• •2. Participant must have a CGI-S score ≥ 4.
• •Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response.