A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia
A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia
The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia
Inclusion Criteria
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.
Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1:
Participant must have a CGI-S score of ≥ 4 at screening and Day -1
Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.
Exclusion Criteria
Clinical.Trials@bms.com855-907-3286
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