A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan

Inclusion Criteria:

1. Must be fully informed of and understand the objectives, procedures, and possiblebenefits and risks of the study, and give written informed consent prior toperforming any study related activities.

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 atScreening

4. Must have a PANSS total score >=60 at Screening and Baseline.

5. Must have a CGI-S score >=3 at Screening and Baseline

6. Judged to be clinically stable (i.e., no evidence of an acute exacerbation) by theInvestigator for at least 8 weeks prior to Baseline and has had no change inantipsychotic medication(s) (minor dose adjustments for tolerability purposes arepermitted) for at least 6 weeks prior to Screening

7. In the opinion of the Investigator, subjects must be generally healthy based onScreening medical history, physical examination, vital signs, ECG, and clinicallaboratory values (hematology, chemistry, and urinalysis).

Exclusion Criteria:

1. Have a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosisother than schizophrenia. Exclusionary disorders include but are not limited toalcohol use disorder or substance (other than nicotine or caffeine) use disorderwithin past 12 months or for a total of >= 10 years during the subject's lifetime,major depressive disorder, bipolar I or II disorder, schizoaffective disorder,obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mildto moderate mood dysphoria or anxiety are allowed so long as these symptoms have notbeen a focus of primary treatment

2. At significant risk of harming self, others, or objects based on Investigator'sjudgment.

3. Have any clinically significant unstable medical condition or any clinicallysignificant chronic disease that in the opinion of the Investigator, would limit thesubject's ability to complete and/or participate in the study.

4. Female subjects who are pregnant or lactating.

5. Have any clinically significant abnormal laboratory value(s) at Screening (hematology, chemistry, and urinalysis) as determined by the Investigator.