Studies bladder effects of KarXT in adults with schizophrenia
Tests KarXT's effect on bladder function and urinary safety in adults with schizophrenia.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Effect of KarXT on Urological Safety
Key facts
- Where
- Austin, Bellflower, Boynton Beach, Chicago, Chino, DeSoto, Garden Grove, Las Vegas, Lauderhill, Little Rock, Marlton, Orange, Philadelphia, Torrance, and West Covina, United StatesSee the 16 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07221877, who can take part
Where in United States
- AustinAustin, United StatesNot yet recruiting
- Clinical Innovations, Inc. dba CITrialsBellflower, United StatesTaking people
- Health Synergy Clinical ResearchBoynton Beach, United StatesTaking people
- Pillar Clinical Research -ChicagoChicago, United StatesTaking people
- Uptown Research InstituteChicago, United StatesTaking people
- Inland Psychiatric Medical Group, IncChino, United StatesTaking people
- Adams Clinical DallasDeSoto, United StatesTaking people
- CenExel CNS - Garden GroveGarden Grove, United StatesTaking people
- IMA Clinical Research - Las VegasLas Vegas, United StatesTaking people
- Innovative Clinical ResearchLauderhill, United StatesTaking people
- Pillar Clinical Research - Little RockLittle Rock, United StatesTaking people
- Hassman Research Institute Marlton SiteMarlton, United StatesTaking people
- ATP Clinical ResearchOrange, United StatesTaking people
- Adams Clinical PhiladelphiaPhiladelphia, United StatesTaking people
- Collaborative Neuroscience Research LLCTorrance, United StatesTaking people
- Kinetic Clinical ResearchWest Covina, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07221877
- Record updated
- 10 November 2026
- Original description
The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.Read full original descriptionShow less
A 12-month Open-label, Phase 4 Multicenter Safety Study to Evaluate the Effect of KarXT on Voiding Dynamics and Urological Safety
The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.
Inclusion: Male and Female participants (age 18 to 65 years of age, with a primary diagnosis of schizophrenia based on psychiatric evaluation (DSM-5) and confirmed by MINI (v 7.0.2); Participants must have a PANSS total score ≤ 80 and CGI-S score ≤ 4, at screening and baseline, and a BMI ≥18 and ≤ 40 kg/m2; Participants must be willing and able to discontinue all antipsychotic medications prior to the baseline visit and be willing and able to comply with protocol requirements.
Exclusion: Participants with newly diagnosed schizophrenia, any other DSM-5 disorder diagnosed within the past 12 months, alcohol or drug use disorder within the past 12 months, history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results; Participants at risk for suicidal behavior, as well as individuals who are pregnant or breastfeeding, will be excluded from the study; Other protocol-defined Inclusion/Exclusion criteria apply.