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Taking people in ArgentinaPhase 3

KarXT to Prevent Relapse in Adults With Schizophrenia

Tests whether KarXT helps keep schizophrenia symptoms from coming back in adults.

Key facts

Who runs it
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Where
Buenos Aires, Córdoba, Río Cuarto, and Santiago del Estero, ArgentinaSee the 5 sitesAlso in 7 other countries, 47 sites
Trial code
Registry title
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Status
Recruiting
Phase
Phase 3
People taking part
472 people, planned
Started
20 Aug 2026
Expected to end
3 Mar 2029
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Xanomeline/Trospium Chloride
  • Placebo
Record updated
30 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with schizophrenia who still have symptoms and were in hospital for it in the past year. It tests whether KarXT helps prevent relapse.

Age
18 Years to 65 Years
Sex
All sexes can join.
Disease stage
Schizophrenia diagnosed at least 1 year ago, with a hospital stay for schizophrenia within the past year and ongoing symptoms (PANSS total score of 70 to 110 and a CGI-S score of 4 or more at screening and Day -1).
Earlier treatment
People with a history of treatment resistance to schizophrenia medications cannot join.

Main reasons for not taking part

  • Any main mental health disorder other than schizophrenia in the 12 months before screening
  • First treated episode of psychosis or schizophrenia, or newly diagnosed
  • Risk of suicidal behavior
  • Psychiatric hospital stays totalling more than 30 days in the 6 months before screening
  • History of treatment resistance to schizophrenia medications

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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:; Item 1 (P1; delusions); Item 2 (P2; conceptual disorganization); Item 3 (P3; hallucinatory behavior); 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

Who cannot take part

  • Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening
  • 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
  • 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 decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%
  • Other protocol-defined Inclusion/Exclusion criteria apply

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in Argentina

Also in 7 other countries, 47 sites

  • Buenos AiresHospital not named in the registryNo longer taking part
  • CórdobaHospital not named in the registryContact: Site 0002Not yet recruiting
  • CórdobaHospital not named in the registryContact: Site 0197Not yet recruiting
  • Río Cuarto, Córdoba ProvinceHospital not named in the registryNo longer taking part
  • Clinica El JardinSantiago del Estero, ArgentinaContact: Gaston Noriega, Site 0144Taking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • KarXTTreatment being tested

    Treatment: Xanomeline/Trospium Chloride

  • PlaceboPlacebo, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia
Plain-language title
KarXT to Prevent Relapse in Adults With SchizophreniaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07686263, who can take part
Record updated
30 October 2026