KarXT to Prevent Relapse in Adults With Schizophrenia
Tests whether KarXT helps keep schizophrenia symptoms from coming back in adults.
Plain-language title generated from the registry record
Registry title: Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Key facts
- Where
- Bialystok, Poznan, and Warsaw, PolandSee the 3 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 Poland
- Uniwersytecki Szpital Kliniczny w BialymstokuBialystok, PolandNot yet recruiting
- Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W PoznaniuPoznan, PolandNot yet recruiting
- Instytut Psychiatrii I NeurologiiWarsaw, PolandNot 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.