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
Researchers are comparing SEP-363856 50 mg, SEP-363856 75 mg and placebo to find out how the approaches affect psychotic symptoms in people with schizophrenia.
Understand this study
What is this study about?
Researchers are comparing SEP-363856 50 mg, SEP-363856 75 mg and placebo to find out how the approaches affect psychotic symptoms in people with schizophrenia.
Who could participate?
This study is for people with schizophrenia. Listed age limits: 18 years to 65 years. Other eligibility criteria apply.
- Listed locations
- Beijing and 53 more locationsSee all locations and recruitment
- Study phase
- Phase 2 / Phase 3This study spans more than one phase, so it may combine goals such as safety, dosing, and early effectiveness.
What to know before participating
This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?
Things to check before joining
- Recruitment status
- Terminated
- Enrollment listed in the registry
- 83
- Sponsor
- Sumitomo Pharma Co., Ltd.
- Sponsor type
- Pharmaceutical company
- Study type
- Drug
- Intervention type
- Drug
- Study phase
- Phase 2 / Phase 3This study spans more than one phase, so it may combine goals such as safety, dosing, and early effectiveness.
- Locations
- China, Japan, Philippines, ...
- Age range
- From 18 Years to 65 Years
- Official registry ID
- NCT04825860
- Official title
Show the full official title
A Randomized, Double-blind, Parallel-group, Placebo Controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP 363856 in Acutely Psychotic Patients With Schizophrenia, Followed by an Open-label Extension Phase
Recruitment & locations
Beijing, China · Guangzhou, China · Changsha, China
46 more locations
- Jining, China
- Shanghai, China
- Xian, China
- Tianjin, China
- Kōnan, Japan
- Toyoake, Japan
- Hachinohe, Japan
- Ichikawa, Japan
- Omuta, Japan
- Ōnojō, Japan
- Aizu-Wakamatsu, Japan
- Mihara, Japan
- Hiratsuka, Japan
- Yokohama, Japan
- Yatsushiro, Japan
- Miyakonojō, Japan
- Matsumoto, Japan
- Ueda, Japan
- Kunigami, Japan
- Higashiosaka, Japan
- Moriguchi, Japan
- Neyagawa, Japan
- Sakai, Japan
- Takatsuki, Japan
- Kanzaki, Japan
- Karatsu, Japan
- Kumagaya, Japan
- Ōtsu, Japan
- Fuchū, Japan
- Kodaira, Japan
- tabashi City, Japan
- Nanto, Japan
- Takaoka, Japan
- Sakata, Japan
- Tendō, Japan
- Akita, Japan
- Fukuoka, Japan
- Kumamoto, Japan
- Miyazaki, Japan
- Mariveles, Philippines
- Iloilo City, Philippines
- Makati City, Philippines
- Mandaluyong, Philippines
- Davao City, Philippines
- Keelung, Taiwan
- Taipei, Taiwan
Interested in joining this study?
Questions about this study
What is this study about?
Researchers are comparing SEP-363856 50 mg, SEP-363856 75 mg and placebo to find out how the approaches affect psychotic symptoms in people with schizophrenia.
Who is behind this study?
The study sponsor is Sumitomo Pharma Co., Ltd., a pharmaceutical company.
Does this study involve medication?
Yes. The study involves medication, including SEP-363856 50 mg, SEP-363856 75 mg and Placebo.
Who can participate?
This study is for people with schizophrenia. Listed age limits: 18 years to 65 years. Other eligibility criteria apply.
Is this study still recruiting?
The registry lists this study as terminated.
