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NCT Number: NCT07101094

Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)

The purpose of this study is to understand treatment preference and satisfaction among adults with schizophrenia in the United States who are prescribed xanomeline and trospium chloride (X/T) therapy

Recruiting

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0009, Orange, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥18 years at index date.
  • Have a confirmed diagnosis of schizophrenia before index date.
  • Receipt of an initial prescription order for xanomeline and trospium chloride (XT) and plan to fill and initiate such therapy.
  • Provide a signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines.
  • Agree to use an electronic device to record, or provide paper entry of, patient-reported outcomes (in English or Spanish).
  • English or Spanish speaking.

Exclusion criteria

  • Participation in an interventional study within the last 30 days or plan to participate in such study at the time of eligibility screening.
  • Evidence of use of XT prior to time of eligibility screening.

Treatment and study plan

xanomeline and trospium chloride (X/T) therapy

Drug

According to the product label

Primary outcomes

  1. Participant medication preference as assessed by the Preference of Medication (POM) questionnaire

    Time frame: Month 1, Month 3, Month 6

  2. Participant treatment satisfaction as assessed by the Medication Satisfaction Questionnaire (MSQ)

    Time frame: Baseline, Month 1, Month 3, Month 6

Secondary outcomes

  1. Treatment titration plan as described by the treating clinician

    Time frame: Baseline, Month 1, Month 3, Month 6

  2. Treatment switch plan as described by the treating physician

    Time frame: Baseline, Month 1, Month 3, Month 6

  3. Treatment dose prescribed

    Time frame: Baseline, Month 1, Month 3, Month 6

  4. Concomitant medication prescribed

    Time frame: Baseline, Month 1, Month 3, Month 6

  5. Number of participants who are prescribed a treatment dose change

    Time frame: Month 1, Month 3, Month 6

  6. Reasons for treatment discontinuation

    Time frame: Month 1, Month 3, Month 6

  7. Participant baseline clinical characteristics

    Time frame: Baseline

  8. Participant baseline demographics

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Real-world Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 3, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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