Can a new drug ease schizophrenia symptoms in daily life?
NCT ID NCT07802132
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study follows 250 Chinese adults with schizophrenia who are prescribed KarXT, a combination of xanomeline and trospium chloride. Over 17 weeks, researchers observe how doctors use the drug, how well patients stick with it, and what side effects occur. The goal is to see if KarXT works safely and effectively outside of a controlled clinical trial setting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- xanomeline and trospium chloride capsules (KarXT)
- What this could lead to
- If KarXT performs well in everyday clinical use, it could offer a new treatment option for schizophrenia with a different side-effect profile than current antipsychotics.
- What could go wrong
- This is an observational study, not a controlled trial, so it cannot prove KarXT works better than other drugs. Results may also be influenced by how doctors choose to prescribe it.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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.
Who is studied
In Chinese adult participants with schizophrenia who meet the International Classification of Diseases (ICD)-10 diagnostic criteria
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Adult participants (age: ≥18 and ≤65 years) who meet the ICD-10 diagnostic criteria for schizophrenia. 2. The participant is capable of providing written informed consent in the study, agrees to receive KarXT monotherapy, is willing to follow the protocol-specified follow-up schedule, and signs the informed consent form, or, where applicable, both the participant and the participant's legal guardian sign the informed consent form. Exclusion Criteria: 1. Participants who have contraindications listed in the prescribing information: urinary retention, moderate or severe hepatic impairment, gastric retention, history of hypersensitivity to this product or trospium chloride, or untreated narrow-angle glaucoma. 2. Participants who have conditions not recommended in the prescribing information, such as moderate or severe renal impairment, mild hepatic impairment, or active biliary disease (e.g., symptomatic gallstones). 3. Participants diagnosed with treatment-resistant schizophrenia (TRS), defined as having previously received at least two courses of treatment with different antipsychotic medications, with each course administered at an adequate dose, as determined by the investigator based on clinical judgment, for at least 4 weeks, but without response. 4. Participants with severe suicidal ideations. Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and C-SSRS as confirmed by the following: Answers "Yes" on items 4 or 5 (C -SSRS ideation) with the most recent episode occurring within the 2 months before screening, or answers "Yes" to any of the 5 items (C-SSRS behavior) with an episode occurring within the 12 months before screening. Non-suicidal self-injurious behavior is not exclusionary. 5. Participants who are pregnant, planning to become pregnant, or breastfeeding. 6. Participants who have any medical conditions that in the investigator's opinion should exclude them from starting KarXT or participate in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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