Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)

ConditionSchizophrenia

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorBristol-Myers Squibb

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population will include adults diagnosed with schizophrenia who initiate treatment with xanomeline and trospium chloride (XT) in the US.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

xanomeline and trospium chloride (X/T) therapy
Drug
According to the product label

Treatment groups

300 Participants

are divided into 1 treatment group

Group A: Participants receiving xanomeline and trospium chloride (X/T) therapy1 intervention

Trial outcomes

Primary outcomes

Participant medication preference as assessed by the Preference of Medication (POM) questionnaire

Time frame

Month 1, Month 3, Month 6

Participant treatment satisfaction as assessed by the Medication Satisfaction Questionnaire (MSQ)

Time frame