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RecruitingPhase 3

Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether KarXT helps prevent relapse in people with schizophrenia. Relapse means symptoms come back or get worse. The study is for people who have had schizophrenia for at least 1 year and were hospitalized for it in the past year.

The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have schizophrenia as your main diagnosis for at least 1 year, confirmed by mental health tests at screening.
  • Have been hospitalized for schizophrenia within 1 year before screening.
  • Still have schizophrenia symptoms, with a PANSS symptom score of 70 to 110 at screening and Day -1.
  • At screening and Day -1, have at least moderate symptoms in 2 or more areas: false beliefs, confused thinking, seeing or hearing things that are not there, or feeling suspicious or targeted.
  • Have a CGI-S score of at least 4 at screening and Day -1. This rating means you are at least moderately ill.
  • Have a body mass index (BMI) of 18 to 40. BMI is a measure based on height and weight.

Who can't join

  • Have had a main mental health diagnosis other than schizophrenia in the 12 months before screening.
  • Have newly diagnosed psychosis or schizophrenia, or are being treated for a first episode. Psychosis means trouble knowing what is real.
  • Be at risk of suicidal behavior, based on the study doctor's review or a suicide risk test.
  • Have spent more than 30 days total in a mental health hospital in the 6 months before screening.
  • Have a history of schizophrenia that has not responded to medicines.
  • Have a drop of more than 20% in your adjusted PANSS symptom score between screening and Day -1.
  • Other study rules for joining or being excluded also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (34)

AR

CA

FL

GA

IL

MD

OH

OK

TX