Schizophrenia Clinical Trial
Official title:
A Multicenter, 52-week, Provider- Randomized, Pragmatic Trial to Assess the Differences in ABILIFY MYCITE - a Digital Medicine System (DMS) Versus Treatment as Usual (TAU) for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole
This is a 12 month, pragmatic trial designed to assess the differences in a digital medicine
system (DMS)- ABILIFY MYCITE (Aripiprazole tablets with sensor)- measuring adherence versus
treatment as usual (TAU) for adult patients with schizophrenia, bipolar I disorder, and major
depression. Outcomes of interest will be adherence as measured by refill rates and all-cause
and psychiatric health care use. Each patient will be in the study for a duration of 12
months.
All treatment medication decisions will be made by the healthcare professionals (HCPs) and
not by protocol. Psychiatrist(s), nurse(s) and/or team manager(s) who will be responsible for
subjects' care, will be considered as HCPs in this trial.
This is a phase 4, 12-month, pragmatic trial designed to assess adherence in patients using
ABILIFY MYCITE versus patients receiving treatment as usual (TAU). Both groups will complete
surveys at baseline, 90, 180, and 360 days and will receive care at the discretion of their
physician. The usual care group will not receive the ABILIFY MYCITE intervention. The primary
outcome will assess refill rates at 6 months.
Eligible patients will enroll at their screening/baseline visit and ABILIFY MYCITE onboarding
will be provided in the clinic, with commercial informational materials and additional call
center support. Patients will then initiate 3 months of treatment with ABILIFY MYCITE at the
baseline visit. At the Day 90 visit, patients will have the opportunity to either stop or
continue using ABILIFY MYCITE for the remainder of the study (9 months). This decision must
be a joint decision with the patient and his or her treating physician. During this optional
interventional phase, patients may start and stop ABILIFY MYCITE as clinically indicated.
All enrolled patients will have required in-person visits at baseline, 90-days, and 180-days.
The day 360 (final) visit can be in-person or via telephone.
Medical and actual pharmacy dispensing data will be collected from day 1 through day 360
using the VA's electronic medical record system.
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