Active Not RecruitingNCT06894212
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Researchers are comparing SEP-363856 and placebo to find out how the approaches affect psychotic symptoms in people with schizophrenia.
Medication studyAges 18–65United States + Japan
Understand this study
What is this study about?
Researchers are comparing SEP-363856 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
- Bentonville and 72 more locationsSee all locations and recruitment
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
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?
Things to check before joining
Study start dateStarted: February 28, 2025
- Recruitment status
- Active Not Recruiting
- Enrollment listed in the registry
- 538
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Sponsor type
- Pharmaceutical company
- Study type
- Drug
- Intervention type
- Medication / drug, OTHER
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
- Locations
- United States, Japan
- Age range
- From 18 Years to 65 Years
- Official registry ID
- NCT06894212
- Official title
Show the full official title
A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Recruitment & locations
Not recruitingBentonville, United States · Little Rock, United States · Rogers, United States
62 more locations
- Bellflower, United States
- Culver City, United States
- Garden Grove, United States
- Lemon Grove, United States
- Montclair, United States
- Riverside, United States
- San Diego, United States
- Sherman Oaks, United States
- Torrance, United States
- Hialeah, United States
- Hollywood, United States
- Miami, United States
- Miami Lakes, United States
- West Palm Beach, United States
- Atlanta, United States
- Decatur, United States
- Peachtree Corners, United States
- Chicago, United States
- New Orleans, United States
- Gaithersburg, United States
- Marlton, United States
- North Canton, United States
- Austin, United States
- DeSoto, United States
- Houston, United States
- Richardson, United States
- Konan-shi, Japan
- Toyoake-shi, Japan
- Hachinohe-shi, Japan
- Chiba, Japan
- Ichikawa-shi, Japan
- Fukuoka, Japan
- Kokuraminami-ku, Kitakyushu-shi, Japan
- Omuta-shi, Japan
- Kōriyama, Japan
- Kure, Japan
- Kure-shi, Japan
- Nayoro-shi, Japan
- Obihiro, Japan
- Sapporo, Japan
- Shiwa-gun, Japan
- Hadano-shi, Japan
- Hiratsuka-shi, Japan
- Yokohama, Japan
- Kumamoto, Japan
- Miyakonojo-shi, Japan
- Moriguchi-shi, Japan
- Neyagawa, Japan
- Kanzaki-gun, Japan
- Karatsu-shi, Japan
- Tosu-shi, Japan
- Ōtsu, Japan
- Shimotsuga-gun, Japan
- Shimotsuke-Shi, Japan
- Utsunomiya, Japan
- Kodaira-shi, Japan
- Machida-shi, Japan
- Setagaya-ku, Japan
- Toyama, Japan
- Sakata-shi, Japan
- Yamagata, Japan
- Wakayama, Japan
A listed location does not confirm current availability.
Questions about this study
What is this study about?
Researchers are comparing SEP-363856 and placebo to find out how the approaches affect psychotic symptoms in people with schizophrenia.
Who is behind this study?
The study sponsor is Otsuka Pharmaceutical Development & Commercialization, Inc., a pharmaceutical company.
Does this study involve medication?
Yes. The study involves medication, including SEP-363856.
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 active, but no longer recruiting.
