A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
NCT ID: NCT06882785
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
250 participants
INTERVENTIONAL
2025-06-10
2029-08-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Administration of KarXT
KarXT
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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KarXT
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 be newly diagnosed or experiencing their first treated episode of schizophrenia.
* Participants must not have any history or presence of clinically significant medical conditions.
18 Years
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Hotei Hospital
Kōnan, Aichi-ken, Japan
Local Institution - 0056
Nagoya, Aichi-ken, Japan
Okehazama Hospital
Toyoake, Aichi-ken, Japan
Fujita Health University
Toyoake, Aichi-ken, Japan
National Kohnodai Medical Center.
Ichikawa, Chiba, Japan
National Hospital Organization Shimofusa Psychiatric Medical Center
MIdori-ku, Chiba-shi, Chiba, Japan
Local Institution - 0032
Iizuka, Fukuoka, Japan
Local Institution - 0037
Kitakyushu, Fukuoka, Japan
Shiranui Hospital
Omuta, Fukuoka, Japan
Takeda General Hospital - Aizuwakamatsu
Aizu-Wakamatsu, Fukushima, Japan
Local Institution - 0044
Toki, Gifu, Japan
Kure Medical Center
Kure, Hiroshima, Japan
Goryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Local Institution - 0025
Hadano-shi, Kanagawa, Japan
Fujimidai Hospital
Hiratsuka, Kanagawa, Japan
Local Institution - 0052
Sagamihara, Kanagawa, Japan
Tsurumi Nishii Hospital
Yokohama, Kanagawa, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Hino Hospital - Yokohama
Yokohama, Kanagawa, Japan
Yuge Hospital
Kumamoto, Kumamoto, Japan
Local Institution - 0019
Yatsushiro, Kumamoto, Japan
National Hospital Organization Maizuru Medical Center
Maizuru, Kyoto, Japan
Miyakonojo Shinsei Hospital
Miyakonojō, Miyazaki, Japan
Local Institution - 0014
Komoro, Nagano, Japan
Local Institution - 0050
Matsumoto, Nagano, Japan
Local Institution - 0051
Ginowan, Okinawa, Japan
Osaka Psychiatric Medical Center
Hirakata, Osaka, Japan
Kansai Medical University Medical Center
Moriguchi, Osaka, Japan
Nagaokai Medical Corporation - Neyagawa Sanatorium
Neyagawa, Osaka, Japan
Shin-Abuyama Hospital
Takatsuki, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, Japan
Inuo Hospital
Tosu, Saga-ken, Japan
Saitama Konan Hospital
Kumagaya, Saitama, Japan
Dokkyo Medical University Hospital
Shimotsuga, Tochigi, Japan
Local Institution - 0043
Utsunomiya, Tochigi, Japan
Local Institution - 0012
Hachiōji, Tokyo, Japan
National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan
Asuka Hospital
Machida, Tokyo, Japan
Local Institution - 0053
Ōta-ku, Tokyo, Japan
Tokyo Metropolitan Matsuzawa Hospital
Setagaya City, Tokyo, Japan
Narimasu Kosei Hospital
tabashi City, Tokyo, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Kuramitsu Hospital
Fukuoka, , Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, , Japan
Miyazaki Prefectural Miyazaki Hospital
Miyazaki, , Japan
Local Institution - 0055
Okayama, , Japan
Local Institution - 0018
Okinawa, , Japan
Local Institution - 0031
Osaka, , Japan
Saitama Neuropsychitric Institute
Saitama, , Japan
Local Institution - 0039
Tokushima, , Japan
Local Institution - 0033
Tottori, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
Yamagata Sakuracho Hospital
Yamagata, , Japan
Countries
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Central Contacts
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First line of the email MUST contain the NCT# and Site#
Role: CONTACT
Facility Contacts
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Takakura Masashi, Site 0034
Role: primary
Site 0056
Role: primary
kiyoshi Fujita, Site 0001
Role: primary
Taro Kishi, Site 0003
Role: primary
Toshihiko Ito, Site 0009
Role: primary
Mitsumoto Onaya, Site 0015
Role: primary
Site 0032
Role: primary
Site 0037
Role: primary
Michihiko Matsushita, Site 0016
Role: primary
Koichi Osonoe, Site 0042
Role: primary
Site 0044
Role: primary
Wataru Omori, Site 0007
Role: primary
Kimihiro Nakajima, Site 0004
Role: primary
Naoki Hashimoto, Site 0049
Role: primary
Site 0025
Role: primary
Takafumi Yahoko, Site 0040
Role: primary
Site 0052
Role: primary
Herbert Nishii, Site 0023
Role: primary
Masatoshi Miyauchi, Site 0028
Role: primary
Atsuomi Baba, Site 0035
Role: primary
Masahiro Shono, Site 0011
Role: primary
Sumihiro Yamano, Site 0046
Role: primary
Masahiko Kawano, Site 0017
Role: primary
Site 0050
Role: primary
Site 0051
Role: primary
Taro Matsuda, Site 0022
Role: primary
SHUNICHIRO IKEDA, Site 0026
Role: primary
Naohiko Matsumoto, Site 0021
Role: primary
Hiroki Kikuyama, Site 0005
Role: primary
Tetsufumi Kanazawa, Site 0024
Role: primary
Taro Shindo, Site 0010
Role: primary
Akifumi Inuo, Site 0038
Role: primary
Narifumi Yokoyama, Site 0020
Role: primary
Norio Furukori, Site 0047
Role: primary
Site 0043
Role: primary
Kyoji Okita, Site 0002
Role: primary
yoshie tamura, Site 0027
Role: primary
Site 0053
Role: primary
Keiko Genda, Site 0045
Role: primary
Yuya Tenjin, Site 0013
Role: primary
Fumihiro Higuchi, Site 0036
Role: primary
Noriko Tamaru, Site 0008
Role: primary
Anri WATANABE, Site 0048
Role: primary
Jiro Kawano, Site 0029
Role: primary
Site 0055
Role: primary
Site 0018
Role: primary
Site 0031
Role: primary
Hakuei Yamashita, Site 0041
Role: primary
Site 0039
Role: primary
Sohei Kimoto, Site 0006
Role: primary
Nobuhiro Yokokawa, Site 0030
Role: primary
Related Links
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BMS Clinical Trial Information
Other Identifiers
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CN012-0019
Identifier Type: -
Identifier Source: org_study_id
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