New hope for schizophrenia: KarXT shows promise in major trial

NCT ID NCT05919823

Disease control Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called KarXT in 202 Chinese adults hospitalized for schizophrenia. The goal was to see if KarXT could reduce symptoms like hallucinations and delusions better than a placebo over 5 weeks, followed by a 12-week period where everyone received the drug. The trial is complete, and results will show if KarXT is a safe and effective option for managing this serious mental illness.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

202 people

The number who actually took part.

Started

May 2023

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject is Chinese national, aged 18 to 65 years, inclusive, at screening. 2. Subject is capable of providing written informed consent. 3. Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 and MINI. 4. Subject is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening. 1. The subject requires hospitalization for this acute exacerbation or relapse of psychotic symptoms at screen. 2. If already an inpatient at screening, hospitalization has to be ≤2 weeks for the current exacerbation at the time of screening. 5. PANSS total score between 80 and 120,inclusive, with a scores of ≥4 (moderate or greater) for ≥2 of the following Positive Scale (P) items: 1. Item 1 (P1; delusions) 2. Item 2 (P2; conceptual disorganization) 3. Item 3 (P3; hallucinatory behavior) 4. Item 6 (P6; suspiciousness/persecution) 6. Subjects with no change (improvement) in PANSS total score between screening and baseline (Day -1) of more than 20%. 7. Subject has a CGI-S score of ≥4 at screening and baseline (Day -1) visits. 8. Subject will have been off lithium therapy for at least 2 weeks before baseline and free of all oral antipsychotic medications for at least 5 half-lives or 1 week, whichever is longer, before baseline (Day -1). 9. Subjects taking a long-acting injectable antipsychotic could not have received a dose of medication for at least 12 weeks (24 weeks for INVEGA TRINZA®) before baseline visit (Day -1). 10. Subject is able to be confined to an inpatient setting for the duration of the 5-week double-blind part of the study, follow instructions, and comply with the protocol requirements. 11. Body mass index of 18 to 40 kg/m2, inclusive. 12. Subject resides in a stable living situation and is anticipated to return to that same stable living situation after discharge, in the opinion of the investigator. 13. Subject has an identified reliable informant. An informant is needed at the screening and baseline visits as well as at the end of the study for relevant assessments (site staff may act as informant while the subject is an inpatient). An informant may not be necessary if the subject has been a patient of the investigator for ≥1 year. 14. Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP must be willing and able to adhere to the contraception guidelines. Exclusion Criteria: 1. Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening). 2. Subjects who are newly diagnosed or are experiencing their first treated episode of schizophrenia. 3. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results. 4. Subjects with human immunodeficiency virus (HIV), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or liver function test results. 5. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma. 6. History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months. 7. Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and C-SSRS. 8. Clinically significant abnormal findings on the physical examination, medical history, electrocardiogram, or clinical laboratory results at screening that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results. 9. Subjects are receiving or have recently received (within 5 half-lives or 1 week, whichever is longer, before baseline \[Day -1\]) oral antipsychotic medications; monoamine oxidase inhibitors; anticonvulsants (e.g., lamotrigine, valproate); tricyclic antidepressants (e.g., imipramine, desipramine); selective serotonin reuptake inhibitors; or any other psychoactive medications except for as-needed anxiolytics (e.g., lorazepam, chloral hydrate). 10. Subjects are receiving or have recently received (within 1 week before baseline \[Day -1\]) metformin. 11. Pregnant, lactating, or less than 3 months postpartum. 12. In the opinion of the investigator and/or Sponsor, subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the investigator and/or Sponsor, may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements. 13. Subject has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before screening. 14. Subject has a history of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) or has required clozapine within the last 12 months. 15. Subjects with prior exposure to KarXT. 16. Subjects who experienced any significant adverse effects due to trospium chloride. 17. Participation in another clinical study within 3 months before screening in which the subject received an experimental or investigational drug agent. 18. Significant risk of violent or destructive behavior.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

Contacts and locations

Locations

Anhui Mental Health Center

Hefei, Anhui, 230022, China
Beijing Anding Hospital Capital Medical University

Beijing, Beijing Municipality, 100035, China
Beijing HuiLongGuan Hospital

Changping, Beijing Municipality, 100096, China
Chongqing 11th People's Hospital

Chongqing, Chongqing Municipality, 400047, China
Chongqing Mental Health Center

Jiangbei, Chongqing Municipality, 401147, China
Daqing City Third Hospital

Daqing, Heilongjiang, 163161, China
Guangyuan Mental Health Center

Guangyuan, Sichuan, 628033, China
Hangzhou Seventh People's Hospital

Hangzhou, Zhejiang, 310013, China
HuZhou Third Municipal Hospital

Huzhou, Zhejiang, 313028, China
Jiangxi Mental Health Center

Nanchang, Jiangxi, 330027, China
Mental Health Center of Xi'an City

Xi'an, Shaanxi, 710061, China
Ningbo Kangning Hospital

Ningbo, Zhejiang, 315002, China
Peking University Sixth Hospital

Beijing, Beijing Municipality, 100083, China
Renmin Hospital of Wuhan University

Wuhan, Hubei, 430064, China
Shandong Daizhuang Hospital

Jining, Shandong, 272009, China
Shandong Mental Health Center

Jinan, Shandong, 250014, China
Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200032, China
The Affiliated Brain Hospital of Guangzhou Medical University

Guanzhou, Guangdong, 510370, China
The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325015, China
The Fourth People's Hospital of Chengdu

Chengdu, Sichuan, 610036, China
The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China
The Sixth People's Hosptial of Hebei Province

Baoding, Hebei, 071051, China
Tianjin Anding Hospital

Tianjin, Tianjin Municipality, 300382, China
Urumqi Fourth People's Hospital

Ürümqi, Xinjiang, 830002, China
Wuhan Mental Health Center

Wuhan, Hubei, 430000, China
Wuhu Hospital of Beijing Anding Hospital

Wuhu, Anhui, 241000, China
Wuxi Mental Health Center

Wuxi, Jiangsu, 214151, China
Zhumadian Second People's Hospital

Zhumadian, Henan, 463001, China

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