SchizophreniaNCT07783373
Long-Term Real-World Safety of Cobenfy in Adults With Schizophrenia
An observational study of Schizophrenia, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This study will evaluate the long-term real-world safety of xanomeline-trospium chloride in adults with schizophrenia receiving routine clinical care in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- xanomeline-trospium chloride and Oral antipsychotics
- Type of treatment
- Pill or oral medicine
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 26 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study will include adults in the United States with schizophrenia who initiate xanomeline-trospium chloride or comparator oral antipsychotics between 27 September 2024 and 26 September 2027.
Who may be able to join
- Age ≥18 years at the index date.
- Either:
- ≥1 inpatient/emergency room claim with a primary diagnosis of schizophrenia; or
- ≥2 office visit claims with a diagnosis of schizophrenia; or
- ≥2 qualifying claims with a diagnosis of schizophrenia plus qualifying psychiatric Current Procedural Terminology (CPT) services.
- ≥1 prescription dispensation claim for xanomeline-trospium chloride or a comparator oral antipsychotic during the study period.
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- Continuous medical and pharmacy coverage during the 183 days before and including the index date.
- No prescription claims for xanomeline-trospium chloride or the index comparator oral antipsychotic during the 183-day baseline period.
- Primary objective: earliest eligible treatment episode included once per participant.
- Secondary objectives: eligible participants may be selected more than once for inclusion in the study. The treatment episode closest to the start of the study period that is eligible for inclusion will be selected as the first treatment episode for each individual. If an individual switches treatment group during the follow-up period, then this will result in another treatment episode for that individual.
Who cannot join
- Prior exposure to xanomeline-trospium chloride or the index comparator oral antipsychotic during the 183-day baseline period.
- Age <18 years.
- Primary outcome: urinary retention during the baseline period or on the index date.
- Secondary outcome: occurrence of sinus tachycardia, syncope resulting from orthostatic hypotension, hypertension, or liver injury during the baseline period or on the index date.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Real-World Safety of Cobenfy in Patients Diagnosed With Schizophrenia
This study will evaluate the long-term real-world safety of xanomeline-trospium chloride in adults with schizophrenia receiving routine clinical care in the United States.
- Conditions
- Schizophrenia
- Being tested
- xanomeline-trospium chloride, Oral antipsychotics
- Keywords
- Schizophrenia, Xanomeline-trospium chloride
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xanomeline-trospium chlorideDrug
As per product label
Oral antipsychoticsDrug
As per product label
| Study group | Role | What they receive |
|---|---|---|
| Xanomeline-trospium chloride | Participants who initiate xanomeline-trospium chloride treatment Receives: Drug: xanomeline-trospium chloride | |
| Comparator Oral Antipsychotics | Participants who initiate first-generation or second-generation oral antipsychotics Receives: Drug: Oral antipsychotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with incident urinary retention
Measured: Up to 3-years
Secondary outcomes (5)
Number of participants with incident biliary disorders
Measured: Up to 3-years
Number of participants with incident sinus tachycardia
Measured: Up to 3-years
Number of participants with incident syncope resulting from orthostatic hypotension
Measured: Up to 3-years
Number of participants with incident hypertension
Measured: Up to 3-years
Number of participants with incident liver injury
Measured: Up to 3-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 May 2026
- Primary completion26 Sep 2027 (estimated)
- Study completion26 Apr 2028 (estimated)
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
- 3,000 participants (estimated)
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
- NCT07783373
- Sponsor's protocol ID
- CN012-0062
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 24 Aug 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Real-World Safety of Cobenfy in Patients Diagnosed With Schizophrenia
- ClinicalTrials.gov ID
- NCT07783373
- Acronym / sponsor ID
- CN012-0062
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Xanomeline-trospium chloride
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 26 Sep 2027 (estimated)
- Study completion
- 26 Apr 2028 (estimated)
- First posted
- 24 Aug 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 will evaluate the long-term real-world safety of xanomeline-trospium chloride in adults with schizophrenia receiving routine clinical care in the United States.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xanomeline-trospium chloride | – | Drug: xanomeline-trospium chlorideParticipants who initiate xanomeline-trospium chloride treatment |
| Comparator Oral Antipsychotics | – | Drug: Oral antipsychoticsParticipants who initiate first-generation or second-generation oral antipsychotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adults in the United States with schizophrenia who initiate xanomeline-trospium chloride or comparator oral antipsychotics between 27 September 2024 and 26 September 2027.
Key inclusion criteria (10 listed)
- Age ≥18 years at the index date.
- Either:
- ≥1 prescription dispensation claim for xanomeline-trospium chloride or a comparator oral antipsychotic during the study period.
- Continuous medical and pharmacy coverage during the 183 days before and including the index date.
- No prescription claims for xanomeline-trospium chloride or the index comparator oral antipsychotic during the 183-day baseline period.
Key exclusion criteria (4 listed)
- Prior exposure to xanomeline-trospium chloride or the index comparator oral antipsychotic during the 183-day baseline period.
- Age <18 years.
- Primary outcome: urinary retention during the baseline period or on the index date.
- Secondary outcome: occurrence of sinus tachycardia, syncope resulting from orthostatic hypotension, hypertension, or liver injury during the baseline period or on the index date.
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 |
|---|---|---|
| xanomeline-trospium chlorideAs per product label | Drug | Xanomeline-trospium chloride |
| Oral antipsychoticsAs per product label | Drug | Comparator Oral Antipsychotics |
Primary outcome
Number of participants with incident urinary retention
Time frame: Up to 3-years
5 secondary outcomes
Number of participants with incident biliary disorders
Time frame: Up to 3-years
Number of participants with incident sinus tachycardia
Time frame: Up to 3-years
Number of participants with incident syncope resulting from orthostatic hypotension
Time frame: Up to 3-years
Number of participants with incident hypertension
Time frame: Up to 3-years
Number of participants with incident liver injury
Time frame: Up to 3-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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 10 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 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?
This study is still under way. Results are not available in the source record yet.
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 participants with incident urinary retention (time frame: Up to 3-years). 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 24 Aug 2026.