Schizophrenia
Conditions
Keywords
Schizophrenia
Brief 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
Interventions
DRUGxanomeline and trospium chloride (X/T) therapy
According to the product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant medication preference as assessed by the Preference of Medication (POM) questionnaire | Month 1, Month 3, Month 6 |
| Participant treatment satisfaction as assessed by the Medication Satisfaction Questionnaire (MSQ) | Baseline, Month 1, Month 3, Month 6 |
Secondary
| Measure | Time frame |
|---|---|
| Treatment titration plan as described by the treating clinician | Baseline, Month 1, Month 3, Month 6 |
| Treatment switch plan as described by the treating physician | Baseline, Month 1, Month 3, Month 6 |
| Treatment dose prescribed | Baseline, Month 1, Month 3, Month 6 |
| Concomitant medication prescribed | Baseline, Month 1, Month 3, Month 6 |
| Number of participants who are prescribed a treatment dose change | Month 1, Month 3, Month 6 |
| Reasons for treatment discontinuation | Month 1, Month 3, Month 6 |
| Participant baseline clinical characteristics | Baseline |
| Participant baseline demographics | Baseline |
Countries
United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed