← Back to Search

Other

KarXT on empty stomach and with food for Schizophrenia

Phase 3
Waitlist Available
Research Sponsored by Karuna Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) for Schizophrenia and Psychotic Disorder Studies version 7.0.2.
* Positive and Negative Syndrome Scale (PANSS) total score of ≤ 80 at screening and Baseline.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 11 weeks
Awards & highlights

Summary

The purpose of this study is to assess the safety and efficacy of slowly increasing dose and food effect of KarXT in adult participants with schizophrenia.

Who is the study for?
This trial is for adults with schizophrenia. Specific eligibility criteria are not provided, but typically participants must meet diagnostic criteria for schizophrenia and be stable enough to participate in a clinical study.
What is being tested?
The trial is testing KarXT, focusing on how safe and effective it is when the dose is increased slowly. It also looks at whether taking the drug with food affects its performance.
What are the potential side effects?
While specific side effects of KarXT are not listed here, common side effects for medications treating schizophrenia may include drowsiness, weight gain, dry mouth, restlessness, and sometimes more serious effects like movement disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 11 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 11 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of treatment-emergent adverse events (TEAEs)
Secondary study objectives
Change from baseline in 12-lead ECG [PR interval (msec)]
Change from baseline in 12-lead ECG [QRS interval (msec)]
Change from baseline in 12-lead ECG [QT interval (msec)]
+27 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: KarXT on empty stomach and with foodExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Karuna TherapeuticsLead Sponsor
13 Previous Clinical Trials
3,406 Total Patients Enrolled
10 Trials studying Schizophrenia
2,326 Patients Enrolled for Schizophrenia
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,539 Previous Clinical Trials
3,375,923 Total Patients Enrolled
13 Trials studying Schizophrenia
4,078 Patients Enrolled for Schizophrenia
~67 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top