RecruitingPhase 3NCT06882785

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

A Phase 3, Randomized, Two-part Study With a 5-week Double-blind Part (Randomized, Parallelgroup, Placebo-controlled) Followed by a 52-week Open-label Extension Part to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Patients With Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) Schizophrenia

Sponsor

Bristol-Myers Squibb

Enrollment

250 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

Schizophrenia

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called KarXT in Japanese adults who are experiencing an acute episode of psychosis related to schizophrenia. The goal is to evaluate how safe and effective the drug is in this population. **You may be eligible if...** - You have a confirmed primary diagnosis of schizophrenia (based on DSM-5 criteria) - You are currently experiencing significant psychotic symptoms (scoring within a specific range on standard psychiatric rating scales) - You are Japanese and an adult **You may NOT be eligible if...** - You have a primary psychiatric diagnosis other than schizophrenia in the past year - This would be your very first treated episode of schizophrenia - You have significant other medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKarXT

Specified dose on specified days

OTHERPlacebo

Specified dose on specified days

Locations(55)

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

Kitasato University Hospital

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

University of the Ryukyus Hospital

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

Toho University Omori Medical Center

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

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NCT06882785

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