Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia
- Conditions
- Schizophrenia
- Registration Number
- NCT06572449
- Lead Sponsor
- Karuna Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria:<br><br> - Has a primary diagnosis of schizophrenia established by a comprehensive psychiatric<br> evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and<br> confirmed by Mini International Neuropsychiatric Interview (MINI) for Schizophrenia<br> and Psychotic Disorder Studies version 7.0.2.<br><br> - Positive and Negative Syndrome Scale (PANSS) total score of = 80 at screening and<br> Baseline.<br><br> - Clinical Global Impression-Severity (CGI-S) score of = 4 at screening and Baseline.<br><br> - Willing and able to discontinue all antipsychotic medications prior to baseline<br> visit.<br><br>Exclusion Criteria:<br><br> - History or presence of clinically significant cardiovascular, pulmonary, renal,<br> hematologic, gastrointestinal (GI), endocrine, immunologic, dermatologic,<br> neurologic, or oncologic disease or any other condition that, in the opinion of the<br> investigator, would jeopardize the safety of the participant or the validity of the<br> study results.<br><br> - Any primary DSM-5 disorder other than schizophrenia within 12 months before<br> screening.<br><br> - History of treatment resistance to schizophrenia medications.<br><br> - History of allergy/hypersensitivity to KarXT.<br><br> - Other protocol-defined Inclusion/Exclusion criteria apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs)
- Secondary Outcome Measures
Name Time Method