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

NCT06882785

RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Schizophrenia

Interventions: KarXT, Placebo

Countries: Japan

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

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (56)
  • Kōnan, Aichi-ken, Japan
  • Nagoya, Aichi-ken, Japan
  • Toyoake, Aichi-ken, Japan
  • Toyoake, Aichi-ken, Japan
  • Ichikawa, Chiba, Japan
  • MIdori-ku, Chiba-shi, Chiba, Japan
  • Iizuka, Fukuoka, Japan
  • Kitakyushu, Fukuoka, Japan
  • Omuta, Fukuoka, Japan
  • Aizu-Wakamatsu, Fukushima, Japan
  • Toki, Gifu, Japan
  • Kure, Hiroshima, Japan
  • Sapporo, Hokkaido, Japan
  • Sapporo, Hokkaido, Japan
  • Hadano-shi, Kanagawa, Japan
  • Hiratsuka, Kanagawa, Japan
  • Sagamihara, Kanagawa, Japan
  • Yokohama, Kanagawa, Japan
  • Yokohama, Kanagawa, Japan
  • Yokohama, Kanagawa, Japan
  • Kumamoto, Kumamoto, Japan
  • Yatsushiro, Kumamoto, Japan
  • Maizuru, Kyoto, Japan
  • Miyakonojō, Miyazaki, Japan
  • Komoro, Nagano, Japan
  • Matsumoto, Nagano, Japan
  • Ginowan, Okinawa, Japan
  • Hirakata, Osaka, Japan
  • Moriguchi, Osaka, Japan
  • Neyagawa, Osaka, Japan
  • + 26 more on CT.gov