A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities. If the subject is considered a minor according to local regulations at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject.
- Male or female between 18 to 65 years of age (inclusive) at the time of consent.
- Must meet DSM 5 criteria for schizophrenia as established by clinical interview at Screening
- Must have a CGI S score ≥ 4 (moderately ill) at Screening and Baseline.
- Must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 (moderate) on 2 or more of the following PANSS items: delusions (P1), conceptual disorganization (P2), hallucinations (P3), and unusual thought content (G9) at Screening and Baseline.
Must have an acute exacerbation of psychotic symptoms (no longer than 2 months prior to providing informed consent for this study). The acute exacerbation should include:
a. Marked deterioration of functioning in one or more areas, such as occupational, social, or personal care or hygiene.
- In the opinion of the Investigator, subjects must be generally healthy based on Screening medical history, physical examination (PE), vital signs, ECG, and clinical laboratory values (hematology, chemistry, and urinalysis).
Exclusion Criteria:
- Have a DSM 5 diagnosis or presence of symptoms consistent with a DSM 5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, or lifetime history of significant substance abuse that, in the opinion of the Investigator, may have had a significant and potentially permanent impact on the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms have not been a focus of primary treatment
- At significant risk of harming self, others, or objects based on Investigator's judgment.
- Have any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
- Female subjects who are pregnant or lactating.
- Have any clinically significant abnormal laboratory value(s) at Screening (hematology, chemistry, and urinalysis) as determined by the Investigator.
Sites / Locations
- Beijing Anding Hospital Capital Medical UniversityRecruiting
- Peking University Sixth HospitalRecruiting
- The Affiliated Brain Hospital of Guangzhou Medical UniversityRecruiting
- The Second People's Hospital of Hunan Province/ Brain Hospital of Hunan ProvinceRecruiting
- Shandong Daizhuang HospitalRecruiting
- Shanghai Mental Health CenterRecruiting
- The Mental Health Center of Xi'anRecruiting
- Tianjin Anding HospitalRecruiting
- Hotei HospitalRecruiting
- Okehazama Hospital Fujita Kokoro Care CenterRecruiting
- Medical corporation Seijinkai Seinan HospitalRecruiting
- Kohnodai Hp., National Center for Global Health and MedicineRecruiting
- Shiranui HospitalRecruiting
- Juzenkai Oorin HospitalRecruiting
- Takeda General HospitalRecruiting
- Mihara HospitalRecruiting
- Fujimidai HospitalRecruiting
- Okinawa Tokushukai Hino HospitalRecruiting
- Yatsushiro Kosei HospitalRecruiting
- Miyakonojo Shinsei HospitalRecruiting
- Shonan HospitalRecruiting
- Mental Support Soyokaze HospitalRecruiting
- NHO Ryukyu HospitalRecruiting
- Social welfare corporation Tenshinkai Kosaka hospitalRecruiting
- Kansai Medical University Medical CenterRecruiting
- Nishiurakai Keihan HospitalRecruiting
- Neyagawa SanatoriumRecruiting
- Asakayama HospitalRecruiting
- Osaka Institute of Clinical Psychiatry Shin-abuyama HospitalRecruiting
- NHO Hizen Psychiatric CenterRecruiting
- Rainbow & Sea HospitalRecruiting
- Nishi Kumagaya HospitalRecruiting
- Shiga university of medical science hospitalRecruiting
- Negishi HospitalRecruiting
- Narimasu Kosei HospitalRecruiting
- National Center of Neurology and PsychiatryRecruiting
- National Hospital Organization Hokuriku National HospitalRecruiting
- Azusakai Kawada HospitalRecruiting
- Sanyokai Sanyo HospitalRecruiting
- Akino HospitalRecruiting
- Akita City HospitalRecruiting
- Inokuchi Noma HospitalRecruiting
- Kuramitsu HospitalRecruiting
- Minkodo Aburayama HospitalRecruiting
- Satokai Yuge HospitalRecruiting
- Miyazaki Prefectural Miyazaki HospitalRecruiting
- Mariveles Mental Wellness and General HospitalRecruiting
- St. Paul's Hospital of Iloilo, Inc.Recruiting
- Makati Medical CenterRecruiting
- National Center for Mental HealthRecruiting
- Southern Philippines Medical CenterRecruiting
- Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationRecruiting
- Kaohsiung Municipal Kai-Syuan Psychiatric HospitalRecruiting
- Chang Gung Memorial Hospital, KeelungRecruiting
- Jianan Psychiatric Center, Ministry of Health and WelfareRecruiting
- National Taiwan University HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
SEP-363856 50 mg/day
SEP-363856 75 mg/day
Placebo
Subjects randomized to the SEP-363856 50 mg/day group will receive the assigned dose of SEP-363856 50 mg/day throughout the double-blind phase.
Subjects randomized to the SEP-363856 75 mg/day group will receive SEP-363856 50 mg/day on Day 1 through Day 3 and then the assigned dose of SEP-363856 75 mg/day thereafter.
Subjects randomized to the placebo group will receive placebo throughout the double-blind phase.