Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT06882785

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

Led by Bristol-Myers Squibb · Updated on 2026-05-13

250

Participants Needed

56

Research Sites

219 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have a primary diagnosis of schizophrenia based on DSM-5 criteria confirmed by a psychiatric interview
  • Participants must have a PANSS total score between 80 and 120, inclusive
  • Participants must have a Clinical Global Impression-Severity (CGI-S) score of 4 or higher
  • Participants must be between 18 and 65 years old
Not Eligible

You will not qualify if you...

  • 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 and exclusion criteria apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 56 locations

1

Hotei Hospital

Kōnan, Aichi-ken, Japan, 4838248

Actively Recruiting

2

Local Institution - 0056

Nagoya, Aichi-ken, Japan, 466-8560

Not Yet Recruiting

3

Okehazama Hospital

Toyoake, Aichi-ken, Japan, 470-1168

Actively Recruiting

4

Fujita Health University

Toyoake, Aichi-ken, Japan, 470-1192

Actively Recruiting

5

National Kohnodai Medical Center.

Ichikawa, Chiba, Japan, 272-8516

Actively Recruiting

6

National Hospital Organization Shimofusa Psychiatric Medical Center

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

Actively Recruiting

7

Local Institution - 0032

Iizuka, Fukuoka, Japan, 820-0014

Withdrawn

8

Local Institution - 0037

Kitakyushu, Fukuoka, Japan, 803-0831

Not Yet Recruiting

9

Shiranui Hospital

Omuta, Fukuoka, Japan, 836-0004

Actively Recruiting

10

Takeda General Hospital - Aizuwakamatsu

Aizu-Wakamatsu, Fukushima, Japan, 965-0876

Actively Recruiting

11

Local Institution - 0044

Toki, Gifu, Japan, 509-5142

Not Yet Recruiting

12

Kure Medical Center

Kure, Hiroshima, Japan, 737-0023

Actively Recruiting

13

Goryokai Medical Corporation - Goryokai Hospital

Sapporo, Hokkaido, Japan, 002-8029

Actively Recruiting

14

Hokkaido University Hospital

Sapporo, Hokkaido, Japan, 0608648

Actively Recruiting

15

Local Institution - 0025

Hadano-shi, Kanagawa, Japan, 257-0003

Not Yet Recruiting

16

Fujimidai Hospital

Hiratsuka, Kanagawa, Japan, 259-1205

Actively Recruiting

17

Kitasato University Hospital

Sagamihara, Kanagawa, Japan, 252-0375

Actively Recruiting

18

Tsurumi Nishii Hospital

Yokohama, Kanagawa, Japan, 230-0074

Actively Recruiting

19

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan, 232-0024

Actively Recruiting

20

Hino Hospital - Yokohama

Yokohama, Kanagawa, Japan, 234-0051

Actively Recruiting

21

Yuge Hospital

Kumamoto, Kumamoto, Japan, 861-8002

Actively Recruiting

22

Local Institution - 0019

Yatsushiro, Kumamoto, Japan, 866-0043

Withdrawn

23

National Hospital Organization Maizuru Medical Center

Maizuru, Kyoto, Japan, 625-8502

Actively Recruiting

24

Miyakonojo Shinsei Hospital

Miyakonojō, Miyazaki, Japan, 885-0093

Actively Recruiting

25

Local Institution - 0014

Komoro, Nagano, Japan, 384-8540

Withdrawn

26

Local Institution - 0050

Matsumoto, Nagano, Japan, 390-0847

Withdrawn

27

University of the Ryukyus Hospital

Ginowan, Okinawa, Japan, 901-2725

Actively Recruiting

28

Osaka Psychiatric Medical Center

Hirakata, Osaka, Japan, 573-0022

Actively Recruiting

29

Kansai Medical University Medical Center

Moriguchi, Osaka, Japan, 570-8507

Actively Recruiting

30

Nagaokai Medical Corporation - Neyagawa Sanatorium

Neyagawa, Osaka, Japan, 572-0854

Actively Recruiting

31

Shin-Abuyama Hospital

Takatsuki, Osaka, Japan, 569-1041

Actively Recruiting

32

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, Japan, 569-8686

Actively Recruiting

33

Rainbow and Sea Hospital

Karatsu-shi, Saga-ken, Japan, 847-0031

Actively Recruiting

34

Inuo Hospital

Tosu, Saga-ken, Japan, 841-0081

Actively Recruiting

35

Saitama Konan Hospital

Kumagaya, Saitama, Japan, 360-0114

Actively Recruiting

36

Dokkyo Medical University Hospital

Shimotsuga, Tochigi, Japan, 321-0293

Actively Recruiting

37

Local Institution - 0054

Shimotsuke, Tochigi, Japan, 329-0498

Not Yet Recruiting

38

Local Institution - 0043

Utsunomiya, Tochigi, Japan, 329-1104

Not Yet Recruiting

39

Local Institution - 0012

Hachiōji, Tokyo, Japan, 192-0153

Withdrawn

40

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan, 187-8551

Actively Recruiting

41

Asuka Hospital

Machida, Tokyo, Japan, 1940005

Actively Recruiting

42

Toho University Omori Medical Center

Ōta-ku, Tokyo, Japan, 143-8541

Actively Recruiting

43

Tokyo Metropolitan Matsuzawa Hospital

Setagaya City, Tokyo, Japan, 1560057

Actively Recruiting

44

Narimasu Kosei Hospital

tabashi City, Tokyo, Japan, 175-0091

Actively Recruiting

45

Yamaguchi University Hospital

Ube, Yamaguchi, Japan, 755-8505

Actively Recruiting

46

Kuramitsu Hospital

Fukuoka, Japan, 819-0037

Actively Recruiting

47

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, Japan, 602-8566

Actively Recruiting

48

Miyazaki Prefectural Miyazaki Hospital

Miyazaki, Japan, 880-8510

Actively Recruiting

49

Okayama University Hospital

Okayama, Japan, 700-8558

Actively Recruiting

50

Local Institution - 0018

Okinawa, Japan, 904-0012

Not Yet Recruiting

51

Local Institution - 0031

Osaka, Japan, 590-0018

Not Yet Recruiting

52

Saitama Neuropsychitric Institute

Saitama, Japan, 338-8577

Actively Recruiting

53

Local Institution - 0039

Tokushima, Japan, 770-8503

Not Yet Recruiting

54

Local Institution - 0033

Tottori, Japan, 689-0203

Withdrawn

55

Wakayama Medical University Hospital

Wakayama, Japan, 641-8510

Actively Recruiting

56

Yamagata Sakuracho Hospital

Yamagata, Japan, 990-0045

Actively Recruiting

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Research Team

B

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

F

First line of the email MUST contain NCT # and Site #.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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