An Open-label Study to Assess the Long-term Safety, Tolerability, Effectiveness, and Durability of Effect of KarXT in Patients With DSM-5 Diagnosis of Schizophrenia

Inclusion Criteria

• •1. Patient is aged 18 to 65 years, inclusive, at screening.
• •2. Patient can provide informed consent.
• •1. A signed informed consent form (ICF) must be provided before any study assessments are performed.
• •2. Patient must be fluent (oral and written) in the language of the ICF to consent.
• •3. Patient has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM 5 (American Psychiatric Association, 2013) criteria and has been in the continuous care of the clinician or practice for at least 6 months prior to entering the study.
• •4. The patient is dissatisfied with the side effects or general tolerability of their current antipsychotic medication, and for this reason, desires to change medications. Or, the patient is dissatisfied with the overall effectiveness or benefit of their current antipsychotic medication, and for this reason, desires to change medications.
• •5. The patient has not required psychiatric hospitalization, acute crisis intervention, or other increase in their level of care due to symptom exacerbation within 4 weeks of screening, and in the opinion of the investigator, is psychiatrically stable to be managed in an outpatient setting.
• •6. The patient has a CGI-S score of ≤4 (moderately severe or less) at screening and baseline visits.
• •7. For at least 30 days prior to screening, the patient must have been prescribed and have taken an oral antipsychotic medication daily at a dose and frequency consistent with the drug label.
• •8. Patient has an identified, reliable caregiver/informant that is willing (by informed consent) and able to respond to the ZBI 22 caregiver burden scale at specified visits. If the patient has been the patient of the investigator for ≥6 months and, in the opinion of the investigator, the patient is self-sufficient, then a caregiver/informant may not be necessary.
• •9. Patient resides in a stable living situation and is anticipated to remain in a stable living situation for the duration of the study, in the opinion of the investigator.
• •10. If a woman of childbearing potential (WOCBP) or a man whose sexual partner(s) is a WOCBP, the patient must be willing and able to adhere to the contraception guidelines as defined in Section 12.1 Appendix 1.