drugset / Trial / NCT03881449
DIMES - DIgital MEdicine Study for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole
Phase 4
Unknown
46 enrolled
Durham VA Medical Center
Otsuka Pharmaceutical Development & Commercialization, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2019-04-04
- Primary completion
- 2021-01
- Completion
- 2021-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole | Other / unclassified | — | — |