CClinicalTrials.gg
CompletedNCT07571148Updated Oct 1, 2026

Real-world Patient Characteristics, Treatment Patterns, and Healthcare Utilization Among KarXT Users

An observational study in Schizophrenia, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Bristol-Myers Squibb · Observational

Updated Oct 1, 2026Now CompletedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
6,876
Ages
18 Years and older
Sex
All
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Study summary

This study uses existing health records and insurance claims data to understand how adults in the United States are treated with KarXT, a medication for schizophrenia. It will describe who receives KarXT, how it is used in real-world practice, and how often healthcare services such as hospital visits are used. It will also explore information recorded by clinicians about schizophrenia symptoms

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Conditions studied

  • Schizophrenia

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Keywords

  • Schizophrenia; KarXT; xanomeline; trospium;
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In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 6,876 is above the median of 178 across 491 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

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

Study population

Adults diagnosed with schizophrenia in the United States with a prescription for KarXT identified in linked electronic health record and administrative claims data.

Inclusion criteria

  • Participants in the Veradigm EHR/claims-linked database with evidence of treatment with KarXT on or after September 24, 2024
  • Earliest KarXT treatment date = index date
  • Aged 18 years or older on index date

Exclusion criteria

Exclusion Criteria:

  • Not applicable
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
6,876 participants (actual)
Patient registry
No

Groups and cohorts

  • Adults treated with KarXT

    Adults aged ≥18 years in the United States with at least one prescription for KarXT on or after September 24, 2024 identified in linked electronic health record and claims data.

    Drug: KarXT (xanomeline and trospium)

Interventions

  • DrugKarXT (xanomeline and trospium)

    As per product label

06

What researchers measure

Primary outcomes

  1. Number of all-cause and schizophrenia-related healthcare encounters per participant

    Number of inpatient admissions, emergency room visits, urgent care visits, and outpatient visits identified from claims and EHR data. Schizophrenia-related encounters are defined as those with a primary diagnosis of schizophrenia using ICD-10-CM codes.

    Time frame: Baseline and up to 6 months

  2. Number of participants adherent to KarXT (proportion of days covered ≥80%)

    Adherence measured using proportion of days covered (PDC), defined as total days of KarXT supply divided by total number of days in the follow-up period. Participants with PDC ≥80% are classified as adherent. Reported as number and percentage of participants meeting adherence criteria.

    Time frame: Baseline and up to 6 months

  3. Time to discontinuation of KarXT

    Time from index date (first KarXT prescription) to discontinuation, defined as a gap of ≥45 consecutive days without KarXT supply.

    Time frame: Baseline and up to 6 months

  4. KarXT initial dose (index dose)

    Distribution of index dose (50 mg/20 mg, 100 mg/20 mg, 125 mg/30 mg, or starter pack)

    Time frame: Baseline

  5. Number of of participants with dose increases or decreases

    Time frame: Baseline and up to 6 months

  6. Number of participants using concomitant antipsychotic and anticholinergic medications

    Time frame: Baseline and up to 6 months

  7. Number of participants with comorbidities

    Time frame: Baseline and up to 6 months

  8. Number of participants with gastrointestinal adverse events

    Time frame: Baseline and up to 6 months

  9. Number of participants with documented schizophrenia symptoms

    Presence of positive and negative schizophrenia symptoms identified using natural language processing (NLP) of unstructured clinical notes, including hallucinations, delusions, disorganized thought, amotivation, avolition, anhedonia, asociality, alogia, and blunted affect.

    Time frame: Baseline and up to 6 months

07

Study locations

1 site
  • Veradigm
    Chicago, Illinois 60654, United States
08

References and documents

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Active, not recruiting→Completed
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07571148
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
May 6, 2026
Start date
Jan 16, 2026
Primary completion
Mar 25, 2026
Completion
Jul 31, 2026
Last update
Oct 1, 2026

Study contacts

Bristol Myers Squibb
study director · Bristol-Myers Squibb

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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