NCT06572449CompletedPhase 3
Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia
A Phase 3b, Open-label, Multicenter, Two-Period, Slow-titration and Food Effect Study to Assess the Safety and Efficacy of KarXT in Participants With DSM-5 Schizophrenia
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 173 (actual)
- First submitted
- 8 Aug 2024
- Start date
- 28 Oct 2024
- Primary completion date
- 13 Mar 2025
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Diseases
- Schizophrenia
- NCT number
- NCT06572449
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 173
- From 28 Oct 2024 to the primary completion date, 13 Mar 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
Other illness
- History or presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
- History of treatment resistance to schizophrenia medications.
- History of allergy/hypersensitivity to KarXT.
Other
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- 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.
- Clinical Global Impression-Severity (CGI-S) score of ≤ 4 at screening and Baseline.
- Willing and able to discontinue all antipsychotic medications prior to baseline visit.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Marlton | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Riverside | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.