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
Qualifiers
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
Treatments tested in this trial
- Xanomeline/Trospium Chloride
- Placebo