Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
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
The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.
Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-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 a SEP-363856 clinical study
Parallel
SEP-363856
Drugtablet
Placebo
Other interventiontablet
The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6
To evaluate the efficacy of SEP-363856 (75 and 100 mg/day) compared with placebo in acutely psychotic participants with schizophrenia. PANSS total - 30-210 Higher score is indicative of greater symptomatology
Clinical Global Impression-Severity (CGI-S)
Change from baseline in CGI-S score at Week 6. CGI-S is 0-7 with higher score is indicative of greater symptomatology
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