Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Key facts
- Where
- Anaheim, Atlanta, Austin, Bellflower, Bentonville, Boynton Beach, Chicago, Cincinnati, Culver City, Gaithersburg, Garden Grove, Hollywood, La Habra, Lemon Grove, Little Rock, Miami, Miami Lakes, Miami Springs, Montclair, Oakland Park, Oklahoma City, Orange, Pico Rivera, Redlands, Richardson, Riverside, Rogers, Sandy Springs, Savannah, and Torrance, United StatesSee the 32 sites
- Phase
- Phase 3
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: NCT07686263, who can take part
Where in United States
- AnaheimAnaheim, United StatesNot yet recruiting
- Atlanta Center for Medical ResearchAtlanta, United StatesTaking people
- AustinAustin, United StatesNot yet recruiting
- Clinical Innovations, Inc. dba CITrialsBellflower, United StatesTaking people
- Pillar Clinical Research - BentonvilleBentonville, United StatesTaking people
- Health Synergy Clinical ResearchBoynton Beach, United StatesTaking people
- ChicagoChicago, United StatesNot yet recruiting
- Pillar Clinical Research -ChicagoChicago, United StatesTaking people
- CincinnatiCincinnati, United StatesNot yet recruiting
- Culver CityCulver City, United StatesNot yet recruiting
- GaithersburgGaithersburg, United StatesNot yet recruiting
- Collaborative NeuroScience Research , LLCGarden Grove, United StatesTaking people
- Research Centers of America (Hollywood)Hollywood, United StatesTaking people
- La HabraLa Habra, United StatesNot yet recruiting
- Lemon GroveLemon Grove, United StatesNot yet recruiting
- Little RockLittle Rock, United StatesNot yet recruiting
- Pillar Clinical Research - Little RockLittle Rock, United StatesTaking people
- MiamiMiami, United StatesNo longer taking part
- Miami LakesMiami Lakes, United StatesNo longer taking part
- Miami SpringsMiami Springs, United StatesNo longer taking part
- MontclairMontclair, United StatesNot yet recruiting
- Oakland ParkOakland Park, United StatesNot yet recruiting
- Oklahoma CityOklahoma City, United StatesNot yet recruiting
- NRC Research InstituteOrange, United StatesTaking people
- Pico RiveraPico Rivera, United StatesNot yet recruiting
- RedlandsRedlands, United StatesNot yet recruiting
- Pillar Clinical Research - RichardsonRichardson, United StatesTaking people
- RiversideRiverside, United StatesNot yet recruiting
- RogersRogers, United StatesNot yet recruiting
- Sandy SpringsSandy Springs, United StatesNot yet recruiting
- SavannahSavannah, United StatesNot yet recruiting
- TorranceTorrance, United StatesNot yet recruiting
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
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Trial code
- NCT07686263EU 2025-523664-20-00
- Record updated
- 30 October 2026
- Original description
The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with SchizophreniaRead full original descriptionShow less
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: 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:; Item 1 (P1; delusions); Item 2 (P2; conceptual disorganization); Item 3 (P3; hallucinatory behavior); Item 6 (P6; suspiciousness/persecution); 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: Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening; Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening; Participant must not have a history of treatment resistance to schizophrenia medications; 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 decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%; Other protocol-defined Inclusion/Exclusion criteria apply.