About this trial
The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.
Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.
Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.
Item 1 (P1; delusions)
Disqualifiers
Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening
Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.
Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).
Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.
Trial design
Parallel
Treatments tested in this trial
Xanomeline/Trospium Chloride
DrugSpecified dose on specified days
Placebo
DrugSpecified dose on specified days
Treatment groups
Trial outcomes
Primary outcomes
Time From Randomization to the First Relapse Event
Secondary outcomes
Time to Discontinuation During Double-blind Treatment Period
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of Participants With Adverse Events of Special Interest (AESIs)
Number of Participants With Procholinergic Symptoms
Sponsors and contacts
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