A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
Launched by BRISTOL-MYERS SQUIBB · Mar 17, 2025
Trial Information
Current as of August 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called KarXT for adults in Japan who are experiencing acute psychosis due to schizophrenia. The main goal is to see how effective and safe KarXT is for these individuals. Schizophrenia is a serious mental health condition that can cause symptoms like hallucinations and delusions. This study is important because it aims to find better treatment options for people facing these challenges.
To participate in this trial, individuals must be adults aged 18 to 65 with a diagnosis of schizophrenia that has been confirmed through a detailed evaluation. They should have a specific score on a mental health assessment tool that shows their symptoms are significant but not at the highest level. However, this study is not looking for people who are newly diagnosed or those with other serious medical conditions. Participants can expect to be closely monitored throughout the study to ensure their safety and to gather information on how well the treatment works. If you or someone you know is interested, it's good to know that the trial is not yet recruiting, but it will be an option in the future.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- • Participants must have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders⎯Fifth Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI).
- • Participants must have a PANSS total score between 80 and 120, inclusive.
- • Participants must have a CGI-S score of ≥ 4.
- • Exclusion Criteria
- • Participants must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
- • Participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia.
- • Participants must not have any history or presence of clinically significant medical conditions.
- • Other protocol-defined Inclusion/Exclusion criteria apply.
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ube, Yamaguchi, Japan
Wakayama, , Japan
Takatsuki, Osaka, Japan
Fukuoka, , Japan
Moriguchi, Osaka, Japan
Sapporo, Hokkaido, Japan
Takatsuki, Osaka, Japan
Karatsu Shi, Saga Ken, Japan
Yokohama, Kanagawa, Japan
Konan, Aichi, Japan
Toyoake, Aichi, Japan
Toyoake, Aichi, Japan
Ichikawa, Chiba, Japan
Iizuka City, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Omuta, Fukuoka, Japan
Kure, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Hadano Shi, Kanagawa, Japan
Hiratsuka, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Kumamoto City, Kumamoto, Japan
Yatsushiro, Kumamoto, Japan
Miyakonojo, Miyazaki, Japan
Komoro, Nagano, Japan
Hirakata, Osaka, Japan
Moriguchi, Osaka, Japan
Neyagawa, Osaka, Japan
Takatsuki, Osaka, Japan
Takatsuki, Osaka, Japan
Karatsu Shi, Saga Ken, Japan
Tosu, Saga, Japan
Kumagaya, Saitama, Japan
Utsunomiya, Tochigi, Japan
Hachioji, Tokyo, Japan
Itabashi City, Tokyo, Japan
Kodaira, Tokyo, Japan
Machida, Tokyo, Japan
Ube, Yamaguchi, Japan
Chiba, , Japan
Fukuoka, , Japan
Miyazaki, , Japan
Okinawa, , Japan
Osaka, , Japan
Saitama, , Japan
Tokushima, , Japan
Tottori, , Japan
Wakayama, , Japan
Yamagata, , Japan
Midori Ku, Chiba Shi, Chiba, Japan
Toki, Gifu, Japan
Setagaya, Tokyo, Japan
Maizuru, Kyoto, Japan
Saitama, , Japan
Aizuwakamatsu, Fukushima, Japan
Yokohama, Kanagawa, Japan
Shimotsuga, Tochigi, Japan
Toyoake, Aichi, Japan
Sapporo, Hokkaido, Japan
Miyakonojo, Miyazaki, Japan
Matsumoto, Nagano, Japan
Kyoto, , Japan
Kumamoto City, Kumamoto, Japan
Ginowan, Okinawa, Japan
Neyagawa, Osaka, Japan
Itabashi City, Tokyo, Japan
Konan, Aichi, Japan
Ichikawa, Chiba, Japan
Hiratsuka, Kanagawa, Japan
Sagamihara, Kanagawa, Japan
Kumagaya, Saitama, Japan
Machida, Tokyo, Japan
Konan, Aichi, Japan
Nagoya, Aichi, Japan
Yokohama, Kanagawa, Japan
ōta, Tokyo, Japan
Saitama, , Japan
Yamagata, , Japan
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported