Schizophrenia
Conditions
Interventions
SEP-363856 (75 and 100 mg/day) or placebo
Sponsors
Tsunoda Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A primary diagnosis of schizophrenia, as defined by (DSM-5) criteria and confirmed using the Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorder Studies; and experiencing an acute exacerbation or relapse of symptoms. The current exacerbation of psychotic symptoms must persist no longer than 2 months prior to screening and any psychiatric hospitalization associated with the exacerbation = 4 at screening and baseline and the Positive and Negative Syndrome Scale (PANSS) total score >= 80, and a PANSS item score >= 4, moderate or greater, on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinatory behavior, and suspiciousness/persecution at screening and baseline.
Exclusion criteria
Exclusion criteria: -Sexually active participants or persons of childbearing potential (POCBP) 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 IMP -Participants with a body mass index (BMI) 40 kg/m2 at screening. -Participant has had a decrease (improvement of symptoms) of>= 20% on the PANSS total score between screening and baseline. -Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia -Participants presenting with a first episode of schizophrenia based on the clinical judgment of the investigator. -Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening. -Participants with a lifetime history of treatment with clozapin -Participants NOT willing or able to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period -Participant has received electroconvulsive therapy treatment within the 3 months prior to screening or is expected to require electroconvulsive therapy during the trial. -Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the investigator, would limit the participant's ability to complete and/or participate in the trial -Participant has any clinically significant abnormal laboratory value(s) at screening (hematology, chemistry, and urinalysis), including but not limited to meeting at least one of the specific criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of SEP-363856 (75and 100 mg/day) compared with placebo in acutely psychotic participants with schizophrenia. | — |
Countries
Japan, The United States
Contacts
Public ContactDrug Information Center
Otsuka Pharmaceutical Co., LTD.
Outcome results
None listed