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RecruitingNCT07101094Updated Sep 30, 2026

Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)

An observational study in Schizophrenia, sponsored by Bristol-Myers Squibb. Recruiting at 20 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Schizophrenia

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Keywords

  • Schizophrenia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will include adults diagnosed with schizophrenia who initiate treatment with xanomeline and trospium chloride (XT) in the US.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Participants receiving xanomeline and trospium chloride (X/T) therapy

    Drug: xanomeline and trospium chloride (X/T) therapy

Interventions

  • Drugxanomeline and trospium chloride (X/T) therapy

    According to the product label

05

What researchers measure

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

06

Study locations

14 of 20 sites recruiting
  • ATP Clinical Research - Costa Mesa
    Orange, California 92866, United States
    • Gustavo Alva, Site 0009 · Contact · 714-277-4472
    Recruiting
  • Lumos Clinical Research Center
    San Jose, California 95124, United States
    • Sarbani Maitra, Site 0010 · Contact · 408-668-2712
    Recruiting
  • Local Institution - 0019
    Miami, Florida 33176, United States
    • Site 0019 · Contact
    Not yet recruiting
  • Evanston Hospital
    Evanston, Illinois 60201, United States
    • Joshua Straus, Site 0003 · Contact · 312-399-3795
    Recruiting
  • The Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
    • Frederick Nucifora, Site 0007 · Contact · 215-620-3793
    Recruiting
  • Local Institution - 0017
    Bel Air, Maryland 21015, United States
    Withdrawn
  • Local Institution - 0004
    Catonsville, Maryland 21228, United States
    Withdrawn
  • Local Institution - 0008
    Belmont, Massachusetts 02478-1064, United States
    Completed
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
    • Hannah Brown, Site 0002 · Contact · 617-638-8141
    Recruiting
  • Local Institution - 0011
    South Dartmouth, Massachusetts 02747, United States
    Completed
  • Local Institution - 0020
    Grand Island, Nebraska 68803, United States
    • Site 0020 · Contact
    Not yet recruiting
  • Omaha Insomnia and Psychiatric Services
    Omaha, Nebraska 68144, United States
    • Vithya Selvaraj, Site 0005 · Contact · 402-991-9630
    Recruiting
  • Hackensack Meridian Health - Carrier Clinic
    Belle Mead, New Jersey 08502, United States
    • Stacy Doumas, Site 0001 · Contact
    Recruiting
  • Radial - Manhattan
    New York, New York 10018, United States
    • Owen Muir, Site 0015 · Contact · 929-260-5003
    Recruiting
  • New Dawn Psychiatric Services, PLLC
    Kinston, North Carolina 28501, United States
    • Punitha Rathnam, Site 0016 · Contact · 252-686-8091
    Recruiting
  • New Dimension Group
    Rose Hill, North Carolina 28458, United States
    • Constance Olatidoye, Site 0018 · Contact · 910-233-2813
    Recruiting
  • Westlake Brain Health
    Westlake, Ohio 44145, United States
    • Abdelrahman Abdelaziz, Site 0014 · Contact · 317-560-2391
    Recruiting
  • Continuum Health Providers
    Fort Mill, South Carolina 29708, United States
    • Brian Mika, Site 0006 · Contact
    Recruiting
  • Haracec Clinical Research
    El Paso, Texas 79902, United States
    • Aghaegbulam Uga, Site 0012 · Contact
    Recruiting
  • C-Trilogy Outreach
    Longview, Texas 75601, United States
    • Tracy Hicks, Site 0013 · Contact · 903-576-2629
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07101094
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Aug 3, 2025
Start date
Sep 22, 2025
Primary completion
Jan 31, 2029 (estimated)
Completion
May 14, 2029 (estimated)
Last update
Sep 30, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol Myers Squibb
study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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