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NCT07686263
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Conditions: Schizophrenia
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 472
Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Location: Pillar Clinical Research - Bentonville Bentonville Arkansas
Summary
The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia
Eligibility Criteria
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:
1. Item 1 (P1; delusions)
2. Item 2 (P2; conceptual disorganization)
3. Item 3 (P3; hallucinatory behavior)
4. 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.
Source: ClinicalTrials.gov (NCT07686263). StuddyBuddy aggregates publicly available trial information.