A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia

Last updated: May 12, 2026
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

3

Condition

Schizotypal Personality Disorder (Spd)

Tourette's Syndrome

Mood Disorders

Treatment

Placebo

KarXT

Clinical Study ID

NCT06882785
CN012-0019
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
June 10, 2025
Estimated Completion Date:
August 23, 2029

Connect with a study center

  • Hotei Hospital

    Konan, Aichi 4838248
    Japan

    Site Not Available

  • Local Institution - 0034

    Konan, Aichi 4838248
    Japan

    Site Not Available

  • Local Institution - 0001

    Toyoake, Aichi 470-1168
    Japan

    Site Not Available

  • Local Institution - 0003

    Toyoake, Aichi 470-1192
    Japan

    Site Not Available

  • Hotei Hospital

    Kōnan, Aichi-ken 4838248
    Japan

    Active - Recruiting

  • Local Institution - 0056

    Nagoya, Aichi-ken 466-8560
    Japan

    Site Not Available

  • Fujita Health University

    Toyoake, Aichi-ken 470-1192
    Japan

    Active - Recruiting

  • Okehazama Hospital

    Toyoake, Aichi-ken 470-1168
    Japan

    Active - Recruiting

  • Hotei Hospital

    Kōnan 1858836, Aichi-ken 1865694 4838248
    Japan

    Site Not Available

  • Local Institution - 0056

    Nagoya 1856057, Aichi-ken 1865694 466-8560
    Japan

    Site Not Available

  • Fujita Health University

    Toyoake 6822210, Aichi-ken 1865694 470-1192
    Japan

    Site Not Available

  • Local Institution - 0003

    Toyoake 6822210, Aichi-ken 1865694 470-1192
    Japan

    Site Not Available

  • Okehazama Hospital

    Toyoake 6822210, Aichi-ken 1865694 470-1168
    Japan

    Active - Recruiting

  • Local Institution - 0009

    Ichikawa, Chiba 272-8516
    Japan

    Site Not Available

  • National Kohnodai Medical Center.

    Ichikawa, Chiba 272-8516
    Japan

    Active - Recruiting

  • Local Institution - 0015

    MIdori-ku, Chiba-shi, Chiba 266-0007
    Japan

    Site Not Available

  • National Hospital Organization Shimofusa Psychiatric Medical Center

    MIdori-ku, Chiba-shi, Chiba 266-0007
    Japan

    Active - Recruiting

  • National Kohnodai Medical Center.

    Ichikawa 11837657, Chiba 2113014 272-8516
    Japan

    Site Not Available

  • Local Institution - 0015

    MIdori-ku, Chiba-shi 2113015, Chiba 2113014 266-0007
    Japan

    Site Not Available

  • National Hospital Organization Shimofusa Psychiatric Medical Center

    MIdori-ku, Chiba-shi 2113015, Chiba 2113014 266-0007
    Japan

    Site Not Available

  • Local Institution - 0032

    Iizuka, Fukuoka 820-0014
    Japan

    Site Not Available

  • Local Institution - 0032

    Iizuka-city, Fukuoka 820-0014
    Japan

    Site Not Available

  • Local Institution - 0037

    Kitakyushu, Fukuoka 803-0831
    Japan

    Site Not Available

  • Local Institution - 0016

    Omuta, Fukuoka 836-0004
    Japan

    Site Not Available

  • Shiranui Hospital

    Omuta, Fukuoka 836-0004
    Japan

    Active - Recruiting

  • Local Institution - 0032

    Iizuka 1861835, Fukuoka 1863958 820-0014
    Japan

    Site Not Available

  • Local Institution - 0037

    Kitakyushu 1859307, Fukuoka 1863958 803-0831
    Japan

    Site Not Available

  • Local Institution - 0016

    Omuta 1854083, Fukuoka 1863958 836-0004
    Japan

    Site Not Available

  • Shiranui Hospital

    Omuta 1854083, Fukuoka 1863958 836-0004
    Japan

    Site Not Available

  • Takeda General Hospital - Aizuwakamatsu

    Aizu-Wakamatsu, Fukushima 965-0876
    Japan

    Active - Recruiting

  • Local Institution - 0042

    Aizuwakamatsu, Fukushima 965-0876
    Japan

    Site Not Available

  • Local Institution - 0042

    Aizu-Wakamatsu 6822148, Fukushima 2112922 965-0876
    Japan

    Site Not Available

  • Takeda General Hospital - Aizuwakamatsu

    Aizu-Wakamatsu 6822148, Fukushima 2112922 965-0876
    Japan

    Site Not Available

  • Local Institution - 0044

    Toki, Gifu 509-5142
    Japan

    Site Not Available

  • Local Institution - 0044

    Toki 1850207, Gifu 1863640 509-5142
    Japan

    Site Not Available

  • Kure Medical Center

    Kure, Hiroshima 737-0023
    Japan

    Active - Recruiting

  • Local Institution - 0007

    Kure, Hiroshima 737-0023
    Japan

    Site Not Available

  • Kure Medical Center

    Kure 1858296, Hiroshima 1862413 737-0023
    Japan

    Site Not Available

  • Local Institution - 0007

    Kure 1858296, Hiroshima 1862413 737-0023
    Japan

    Site Not Available

  • Goryokai Medical Corporation - Goryokai Hospital

    Sapporo, Hokkaido 002-8029
    Japan

    Active - Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido 0608648
    Japan

    Active - Recruiting

  • Local Institution - 0004

    Sapporo, Hokkaido 002-8029
    Japan

    Site Not Available

  • Local Institution - 0049

    Sapporo, Hokkaido 0608648
    Japan

    Site Not Available

  • Goryokai Medical Corporation - Goryokai Hospital

    Sapporo 2128295, Hokkaido 2130037 002-8029
    Japan

    Active - Recruiting

  • Hokkaido University Hospital

    Sapporo 2128295, Hokkaido 2130037 0608648
    Japan

    Site Not Available

  • Local Institution - 0049

    Sapporo 2128295, Hokkaido 2130037 0608648
    Japan

    Site Not Available

  • Local Institution - 0025

    Hadano-shi, Kanagawa 257-0003
    Japan

    Site Not Available

  • Fujimidai Hospital

    Hiratsuka, Kanagawa 259-1205
    Japan

    Active - Recruiting

  • Local Institution - 0040

    Hiratsuka, Kanagawa 259-1205
    Japan

    Site Not Available

  • Kitasato University Hospital

    Sagamihara, Kanagawa 252-0375
    Japan

    Active - Recruiting

  • Local Institution - 0052

    Sagamihara, Kanagawa 252-0375
    Japan

    Site Not Available

  • Hino Hospital - Yokohama

    Yokohama, Kanagawa 234-0051
    Japan

    Active - Recruiting

  • Local Institution - 0023

    Yokohama, Kanagawa 230-0074
    Japan

    Site Not Available

  • Local Institution - 0028

    Yokohama, Kanagawa 232-0024
    Japan

    Site Not Available

  • Local Institution - 0035

    Yokohama, Kanagawa 234-0051
    Japan

    Site Not Available

  • Tsurumi Nishii Hospital

    Yokohama, Kanagawa 230-0074
    Japan

    Active - Recruiting

  • Yokohama City University Medical Center

    Yokohama, Kanagawa 232-0024
    Japan

    Active - Recruiting

  • Fujimidai Hospital

    Hiratsuka 1862462, Kanagawa 1860291 259-1205
    Japan

    Site Not Available

  • Local Institution - 0052

    Sagamihara 11611609, Kanagawa 1860291 252-0375
    Japan

    Site Not Available

  • Hino Hospital - Yokohama

    Yokohama 1848354, Kanagawa 1860291 234-0051
    Japan

    Active - Recruiting

  • Local Institution - 0028

    Yokohama 1848354, Kanagawa 1860291 232-0024
    Japan

    Site Not Available

  • Tsurumi Nishii Hospital

    Yokohama 1848354, Kanagawa 1860291 230-0074
    Japan

    Active - Recruiting

  • Yokohama City University Medical Center

    Yokohama 1848354, Kanagawa 1860291 232-0024
    Japan

    Site Not Available

  • Yuge Hospital

    Kumamoto, Kumamoto 861-8002
    Japan

    Active - Recruiting

  • Local Institution - 0011

    Kumamoto-City, Kumamoto 861-8002
    Japan

    Site Not Available

  • Yuge Hospital

    Kumamoto-City, Kumamoto 861-8002
    Japan

    Site Not Available

  • Local Institution - 0019

    Yatsushiro, Kumamoto 866-0043
    Japan

    Site Not Available

  • Yuge Hospital

    Kumamoto 1858421, Kumamoto 1858419 861-8002
    Japan

    Site Not Available

  • Local Institution - 0019

    Yatsushiro 11612334, Kumamoto 1858419 866-0043
    Japan

    Site Not Available

  • Local Institution - 0046

    Maizuru, Kyoto 625-8502
    Japan

    Site Not Available

  • National Hospital Organization Maizuru Medical Center

    Maizuru, Kyoto 625-8502
    Japan

    Active - Recruiting

  • Local Institution - 0046

    Maizuru 1857766, Kyoto 1857907 625-8502
    Japan

    Site Not Available

  • National Hospital Organization Maizuru Medical Center

    Maizuru 1857766, Kyoto 1857907 625-8502
    Japan

    Site Not Available

  • Local Institution - 0017

    Miyakonojo, Miyazaki 885-0093
    Japan

    Site Not Available

  • Miyakonojo Shinsei Hospital

    Miyakonojo, Miyazaki 885-0093
    Japan

    Site Not Available

  • Miyakonojo Shinsei Hospital

    Miyakonojō, Miyazaki 885-0093
    Japan

    Active - Recruiting

  • Miyakonojo Shinsei Hospital

    Miyakonojō 1856775, Miyazaki 1856710 885-0093
    Japan

    Site Not Available

  • Local Institution - 0014

    Komoro, Nagano 384-8540
    Japan

    Site Not Available

  • Local Institution - 0050

    Matsumoto, Nagano 390-0847
    Japan

    Site Not Available

  • Local Institution - 0014

    Komoro 1858858, Nagano 1856210 384-8540
    Japan

    Site Not Available

  • Local Institution - 0050

    Matsumoto 1857519, Nagano 1856210 390-0847
    Japan

    Site Not Available

  • Local Institution - 0051

    Ginowan, Okinawa 901-2725
    Japan

    Site Not Available

  • University of the Ryukyus Hospital

    Ginowan, Okinawa 901-2725
    Japan

    Active - Recruiting

  • Local Institution - 0051

    Ginowan 1863627, Okinawa 1854345 901-2725
    Japan

    Site Not Available

  • University of the Ryukyus Hospital

    Ginowan 1863627, Okinawa 1854345 901-2725
    Japan

    Site Not Available

  • Local Institution - 0022

    Hirakata, Osaka 573-0022
    Japan

    Site Not Available

  • Osaka Psychiatric Medical Center

    Hirakata, Osaka 573-0022
    Japan

    Active - Recruiting

  • Kansai Medical University Medical Center

    Moriguchi, Osaka 570-8507
    Japan

    Active - Recruiting

  • Local Institution - 0026

    Moriguchi, Osaka 570-8507
    Japan

    Site Not Available

  • Local Institution - 0021

    Neyagawa, Osaka 572-0854
    Japan

    Site Not Available

  • Nagaokai Medical Corporation - Neyagawa Sanatorium

    Neyagawa, Osaka 572-0854
    Japan

    Active - Recruiting

  • Local Institution - 0005

    Takatsuki, Osaka 569-1041
    Japan

    Site Not Available

  • Local Institution - 0024

    Takatsuki, Osaka 569-8686
    Japan

    Site Not Available

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, Osaka 569-8686
    Japan

    Active - Recruiting

  • Shin-Abuyama Hospital

    Takatsuki, Osaka 569-1041
    Japan

    Active - Recruiting

  • Local Institution - 0022

    Hirakata 1862540, Osaka 1853904 573-0022
    Japan

    Site Not Available

  • Osaka Psychiatric Medical Center

    Hirakata 1862540, Osaka 1853904 573-0022
    Japan

    Site Not Available

  • Kansai Medical University Medical Center

    Moriguchi 1856584, Osaka 1853904 570-8507
    Japan

    Site Not Available

  • Nagaokai Medical Corporation - Neyagawa Sanatorium

    Neyagawa 6697563, Osaka 1853904 572-0854
    Japan

    Site Not Available

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki 1850910, Osaka 1853904 569-8686
    Japan

    Site Not Available

  • Shin-Abuyama Hospital

    Takatsuki 1850910, Osaka 1853904 569-1041
    Japan

    Active - Recruiting

  • Local Institution - 0038

    Tosu, Saga 841-0081
    Japan

    Site Not Available

  • Local Institution - 0010

    Karatsu-shi, Saga-Ken 847-0031
    Japan

    Site Not Available

  • Rainbow and Sea Hospital

    Karatsu-shi, Saga-ken 847-0031
    Japan

    Active - Recruiting

  • Inuo Hospital

    Tosu, Saga-ken 841-0081
    Japan

    Active - Recruiting

  • Inuo Hospital

    Tosu 1849904, Saga-ken 1853299 841-0081
    Japan

    Site Not Available

  • Local Institution - 0038

    Tosu 1849904, Saga-ken 1853299 841-0081
    Japan

    Site Not Available

  • Local Institution - 0020

    Kumagaya, Saitama 360-0114
    Japan

    Site Not Available

  • Saitama Konan Hospital

    Kumagaya, Saitama 360-0114
    Japan

    Active - Recruiting

  • Saitama Konan Hospital

    Kumagaya 1858428, Saitama 1853226 360-0114
    Japan

    Site Not Available

  • Dokkyo Medical University Hospital

    Shimotsuga, Tochigi 321-0293
    Japan

    Active - Recruiting

  • Local Institution - 0054

    Shimotsuke, Tochigi 329-0498
    Japan

    Site Not Available

  • Local Institution - 0043

    Utsunomiya, Tochigi 329-1104
    Japan

    Site Not Available

  • Local Institution - 0047

    Shimotsuga, Tochigi 1850310 321-0293
    Japan

    Site Not Available

  • Local Institution - 0043

    Utsunomiya 1849053, Tochigi 1850310 329-1104
    Japan

    Site Not Available

  • Local Institution - 0012

    Hachioji, Tokyo 192-0153
    Japan

    Site Not Available

  • Local Institution - 0012

    Hachiōji, Tokyo 192-0153
    Japan

    Site Not Available

  • Local Institution - 0013

    Itabashi City, Tokyo 175-0091
    Japan

    Site Not Available

  • Narimasu Kosei Hospital

    Itabashi City, Tokyo 175-0091
    Japan

    Site Not Available

  • Local Institution - 0002

    Kodaira, Tokyo 187-8551
    Japan

    Site Not Available

  • National Center of Neurology and Psychiatry

    Kodaira, Tokyo 187-8551
    Japan

    Active - Recruiting

  • Asuka Hospital

    Machida, Tokyo 1940005
    Japan

    Active - Recruiting

  • Local Institution - 0027

    Machida, Tokyo 1940005
    Japan

    Site Not Available

  • Local Institution - 0045

    Setagaya, Tokyo 1560057
    Japan

    Site Not Available

  • Tokyo Metropolitan Matsuzawa Hospital

    Setagaya City, Tokyo 1560057
    Japan

    Active - Recruiting

  • Narimasu Kosei Hospital

    tabashi City, Tokyo 175-0091
    Japan

    Active - Recruiting

  • Local Institution - 0053

    Ōta, Tokyo 143-8541
    Japan

    Site Not Available

  • Toho University Omori Medical Center

    Ōta-ku, Tokyo 143-8541
    Japan

    Active - Recruiting

  • Local Institution - 0012

    Hachiōji 1863440, Tokyo 1850144 192-0153
    Japan

    Site Not Available

  • Local Institution - 0002

    Kodaira 11611930, Tokyo 1850144 187-8551
    Japan

    Site Not Available

  • National Center of Neurology and Psychiatry

    Kodaira 11611930, Tokyo 1850144 187-8551
    Japan

    Site Not Available

  • Asuka Hospital

    Machida 1857871, Tokyo 1850144 1940005
    Japan

    Site Not Available

  • Local Institution - 0045

    Setagaya City 11790342, Tokyo 1850144 1560057
    Japan

    Site Not Available

  • Tokyo Metropolitan Matsuzawa Hospital

    Setagaya City 11790342, Tokyo 1850144 1560057
    Japan

    Site Not Available

  • Narimasu Kosei Hospital

    tabashi City 1861321, Tokyo 1850144 175-0091
    Japan

    Site Not Available

  • Local Institution - 0053

    Ōta-ku 8469289, Tokyo 1850144 143-8541
    Japan

    Site Not Available

  • Toho University Omori Medical Center

    Ōta-ku 8469289, Tokyo 1850144 143-8541
    Japan

    Site Not Available

  • Local Institution - 0036

    Ube, Yamaguchi 755-8505
    Japan

    Site Not Available

  • Yamaguchi University Hospital

    Ube, Yamaguchi 755-8505
    Japan

    Active - Recruiting

  • Yamaguchi University Hospital

    Ube 1849498, Yamaguchi 1848681 755-8505
    Japan

    Site Not Available

  • Local Institution - 0015

    Chiba, 266-0007
    Japan

    Site Not Available

  • Kuramitsu Hospital

    Fukuoka, 819-0037
    Japan

    Active - Recruiting

  • Local Institution - 0008

    Fukuoka, 819-0037
    Japan

    Site Not Available

  • Kuramitsu Hospital

    Fukuoka 1863967, 819-0037
    Japan

    Site Not Available

  • Local Institution - 0048

    Kyoto, 602-8566
    Japan

    Site Not Available

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, 602-8566
    Japan

    Active - Recruiting

  • Local Institution - 0048

    Kyoto 1857910, 602-8566
    Japan

    Site Not Available

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto 1857910, 602-8566
    Japan

    Site Not Available

  • Local Institution - 0029

    Miyazaki, 880-8510
    Japan

    Site Not Available

  • Miyazaki Prefectural Miyazaki Hospital

    Miyazaki, 880-8510
    Japan

    Active - Recruiting

  • Local Institution - 0029

    Miyazaki 1856717, 880-8510
    Japan

    Site Not Available

  • Miyazaki Prefectural Miyazaki Hospital

    Miyazaki 1856717, 880-8510
    Japan

    Site Not Available

  • Local Institution - 0055

    Okayama, 700-8558
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • Local Institution - 0055

    Okayama 1854383, 700-8558
    Japan

    Site Not Available

  • Local Institution - 0018

    Okinawa, 904-0012
    Japan

    Site Not Available

  • Local Institution - 0018

    Okinawa 1894616, 904-0012
    Japan

    Site Not Available

  • Local Institution - 0031

    Osaka, 590-0018
    Japan

    Site Not Available

  • Local Institution - 0031

    Osaka 1853909, 590-0018
    Japan

    Site Not Available

  • Local Institution - 0041

    Saitama, 338-8577
    Japan

    Site Not Available

  • Saitama Neuropsychitric Institute

    Saitama, 338-8577
    Japan

    Active - Recruiting

  • Saitama Neuropsychitric Institute

    Saitama 6940394, 338-8577
    Japan

    Site Not Available

  • Local Institution - 0039

    Tokushima, 770-8503
    Japan

    Site Not Available

  • Local Institution - 0039

    Tokushima 1850158, 770-8503
    Japan

    Site Not Available

  • Local Institution - 0033

    Tottori, 689-0203
    Japan

    Site Not Available

  • Local Institution - 0033

    Tottori 1849893, 689-0203
    Japan

    Site Not Available

  • Local Institution - 0006

    Wakayama, 641-8510
    Japan

    Site Not Available

  • Wakayama Medical University Hospital

    Wakayama, 641-8510
    Japan

    Active - Recruiting

  • Wakayama Medical University Hospital

    Wakayama 1926004, 641-8510
    Japan

    Site Not Available

  • Local Institution - 0030

    Yamagata, 990-0045
    Japan

    Site Not Available

  • Yamagata Sakuracho Hospital

    Yamagata, 990-0045
    Japan

    Active - Recruiting

  • Yamagata Sakuracho Hospital

    Yamagata 2110556, 990-0045
    Japan

    Site Not Available

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