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TerminatedNCT04825860

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.

Medication studyAges 18–65Multiple countries
The study in practice

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.

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What to know before participating

A point to clarify

This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?

Study clarity

Things to check before joining

Study start dateStarted: March 29, 2021
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

Terminated

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

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FAQ

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.

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