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OpenTrials
Active, Not Recruiting

NCT Number: NCT07571148

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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

Veradigm

Chicago, Illinois, 60654, United States

Who can participate

Healthy volunteers accepted: No

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

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

  • Not applicable

Treatment and study plan

KarXT (xanomeline and trospium)

Drug

As per product label

Primary outcomes

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

    Time frame: Baseline and up to 6 months

    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.

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

    Time frame: Baseline and up to 6 months

    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.

  3. Time to discontinuation of KarXT

    Time frame: Baseline and up to 6 months

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

  4. KarXT initial dose (index dose)

    Time frame: Baseline

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

  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

    Time frame: Baseline and up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

The Current Landscape of Cobenfy (KarXT): Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 6, 2026
Registry last updated
May 6, 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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