SchizophreniaNCT07571148
Real-world Patient Characteristics, Treatment Patterns, and Healthcare Utilization Among KarXT Users
An observational study of Schizophrenia, run by Bristol-Myers Squibb at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- KarXT (xanomeline and trospium)
- How many people
- 6,876 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2026to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Current Landscape of Cobenfy (KarXT): Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization
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
- Conditions
- Schizophrenia
- Being tested
- KarXT (xanomeline and trospium)
- Keywords
- Schizophrenia; KarXT; xanomeline; trospium;
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KarXT (xanomeline and trospium)Drug
As per product label
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: KarXT (xanomeline and trospium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and up to 6 months
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.
Measured: Baseline and up to 6 months
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.
Measured: Baseline and up to 6 months
KarXT initial dose (index dose)
Distribution of index dose (50 mg/20 mg, 100 mg/20 mg, 125 mg/30 mg, or starter pack)
Measured: Baseline
Number of of participants with dose increases or decreases
Measured: Baseline and up to 6 months
Number of participants using concomitant antipsychotic and anticholinergic medications
Measured: Baseline and up to 6 months
Number of participants with comorbidities
Measured: Baseline and up to 6 months
Number of participants with gastrointestinal adverse events
Measured: Baseline and up to 6 months
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.
Measured: Baseline and up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start16 Jan 2026
- Primary completion25 Mar 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,876 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571148
- Sponsor's protocol ID
- CN012-0080
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Current Landscape of Cobenfy (KarXT): Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization
- ClinicalTrials.gov ID
- NCT07571148
- Acronym / sponsor ID
- CN012-0080
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia; KarXT; xanomeline; trospium;
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,876 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults treated with KarXT | – | Drug: KarXT (xanomeline and trospium)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KarXT (xanomeline and trospium)As per product label | Drug | Adults treated with KarXT |
Primary outcome
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.
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.
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.
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)
Number of of participants with dose increases or decreases
Time frame: Baseline and up to 6 months
Number of participants using concomitant antipsychotic and anticholinergic medications
Time frame: Baseline and up to 6 months
Number of participants with comorbidities
Time frame: Baseline and up to 6 months
Number of participants with gastrointestinal adverse events
Time frame: Baseline and up to 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of all-cause and schizophrenia-related healthcare encounters per participant (time frame: Baseline and up to 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.