An observational study in Schizophrenia Disorder, sponsored by Zai Lab (Shanghai) Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Zai Lab (Shanghai) Co., Ltd. (part of Zai Lab Limited) · Observational
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This study is a prospective, observational, single-arm, open-label, multicenter, real-world study conducted in Chinese adult participants with schizophrenia who meet the International Classification of Diseases (ICD)-10 diagnostic criteria. The total study duration is up to 17 weeks, including a screening/baseline data collection period followed by an observational part during which KarXT treatmentpattern, schizophrenia treatment decisions and compliance will be observed in the real-world setting.
3,565 studies on the registry are indexed under Schizophrenia; 493 are open to participants now.
This study's planned enrollment of 250 is above the median of 178 across 507 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →Zai Lab (Shanghai) Co., Ltd. is the lead sponsor of 25 studies on the registry; 8 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
In Chinese adult participants with schizophrenia who meet the International Classification of Diseases (ICD)-10 diagnostic criteria
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participant is capable of providing written informed consent in this study, agrees to receive KarXT monotherapy
Drug: Xanomeline and trospium chloride (KarXT)
Drug pages: Xanomeline · Trospium chloride
Participants will receive KarXT for a treatment/observation period of 17 weeks. The recommended dosage and administration of KarXT should refer to the prescribing information: The recommended starting dosage is one 50 mg/20 mg capsule orally twice daily for at least two days, then increase to one 100 mg/20 mg capsule orally twice daily for at least five days, the dosage may be increased to one 125 mg/30 mg capsule orally twice daily based on participant tolerability and response. All participants who are increased to 125 mg/30 mg, depending on clinician's decision, will have the option to return to 100 mg/20 mg for the remainder of the treatment/observation period. Maintenance doses may be set at 125 mg/30 mg or 100 mg/20 mg twice daily.
KarXTtreatment pattern according to clinicians'decision
Treatment duration (days)for each doseof KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 17
Time frame: through Week 17
KarXTtreatment pattern according to clinicians'decision
Proportion(%)of participants on each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) at Week 17
Time frame: Week 17
KarXT Safety Profile
Proportion (%)of KarXT-related adverse events (TRAEs) through Week 17
Time frame: through Week 17
KarXT Treatment PatternAccording to Clinicians'Decision
Treatment duration (days) for each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 5
Time frame: through Week 5
KarXT Safety Profile
Proportion (%)of serious adverse events (SAEs) through Week 17
Time frame: through Week 17
KarXT Treatment Effectiveness
Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 17
Time frame: Week 17
KarXT Treatment Effectiveness
Change from baseline in the Clinical Global Impression-Severity (CGI-S) score at Week 17
Time frame: Week 17
Schizophrenia Treatment Decisions and Compliance in the Real-world Setting
Proportion (%) of participants discontinuing KarXT treatment along with the documented reasons for the decision from baseline through Week 17
Time frame: through Week 17
KarXT Treatment PatternAccording to Clinicians'Decision
Proportion (%) of participants on each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 5
Time frame: through Week 5
Change from baseline in social functional recovery metrics captured via continuous wearable wristband device
Change from baseline in social functional recovery metrics captured via continuous wearable wristband device (sleep onset time, wake time, total sleep duration, heart rate, heart rate variability, total daily step count, sedentary duration, and activity interruptions)
Time frame: Baseline and Week 17
Change from baseline in the proportion of patient-reported outcome in the surveys in binary states across four Ecological Momentary Assessment (EMA) dimensions
Observed Ecological Momentary Assessment (EMA) patient-reported outcomes (PRO) in participants with schizophrenia: Change from baseline in the proportion of patient-reported outcome in the surveys in binary states across four Ecological Momentary Assessment (EMA) dimensions: location (at home vs. outdoors), sociality context (alone vs. with others), activity type (productive vs. non-productive), and affect profile (positive vs. negative) at Week 17
Time frame: Baseline and Week 17
Change From Baseline in the Zarit Caregiver Burden Interview (ZBI) Score
Change from baseline in caregiver burden, assessed by the Zarit Caregiver Burden Interview (ZBI)
Time frame: Baseline and Week 17
Change From Baseline in the PANSS Marder Negative Factor Score
Change from baseline in the PANSS Marder negative factor score
Time frame: Baseline and Week 17
Change From Baseline in the Personal and Social Performance Scale (PSP) Score
Change from baseline in the Personal and Social Performance Scale (PSP) score
Time frame: Baseline and Week 17
Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) Score
Change from baseline in participant treatment satisfaction measured by the Medication Satisfaction Questionnaire (MSQ)
Time frame: Baseline and Week 17
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Aug 2027, 11 months later.
Of 136 observational studies under Schizophrenia, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 102. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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