NCT07686263 · Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
What this study is about
The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia
View original scientific description
The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia
Interventions
DRUG
Xanomeline/Trospium Chloride
Specified dose on specified days
DRUG
Placebo
Specified dose on specified days
Primary outcome measures
Time From Randomization to the First Relapse Event
Time frame: Up to approximately Week 43
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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 criteria
- Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening
- 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 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
- 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.
Where
- Bentonville, Arkansas
- Little Rock, Arkansas
- Rogers, Arkansas
- Anaheim, California
- Bellflower, California
- Chino, California
- Culver City, California
- Garden Grove, California
- La Habra, California
- Lemon Grove, California
- Montclair, California
- Orange, California
And 20 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 14, 2026 · Source of record for eligibility and locations