A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Summary
The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 (mode…
Interventions
- DrugXanomeline/Trospium Chloride
Specified dose on specified days
- DrugPlacebo
Specified dose on specified days
Locations (59)
- Pillar Clinical Research - BentonvilleBentonville, Arkansas
- Pillar Clinical Research- Little RockLittle Rock, Arkansas
- Local Institution - 0021Little Rock, Arkansas
- Local Institution - 0153Rogers, Arkansas
- Local Institution - 0190Anaheim, California
- Local Institution - 0040Bellflower, California