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Psych Congress  

A Multicenter, 8-Week, Open-Label Study to Assess Usability of a Digital Medicine System in Adult Patients With Schizophrenia Treated With Oral Aripiprazole

Alex Kopelowicz, MD; Ross A. Baker, PhD, MBA; Cathy Zhao, PhD, MS, BS; Raymond Sanchez, MD; Margaretta Nyilas, MD; Claudette Brewer, BA; Erica Lawson; Timothy Peters-Strickland, MD
Otsuka Pharmaceutical Development & Commercialization, Inc.

This poster was presented at the 30th annual  Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.

Introduction: A Digital Medicine System (DMS) has been developed to objectively measure and report a patient's medication ingestion. This study tested the functionality of an integrated call center for the DMS in adult subjects with schizophrenia (SCH), bipolar 1 disorder (BP1) or major depressive disorder (MDD) treated with oral aripiprazole.

Methods: Four US sites enrolled patients with SCH, BP1, or MDD stabilized on oral aripiprazole. Primary outcome was the establishment of a functional and operational integrated call center with coordinated feedback to the subject and investigative site to optimize the use of the DMS as measured by inbound and outbound calls by help type. NCT02722967.

Results: 51 patients were screened and 49 enrolled; 38/49 (77.6%) completed the 8-week study. No differences in completion rates were observed among patients with SCH 11/15 (73.3%), BP1 17/22 (77.3%) or MDD 10/12 (83.3%). The most common inbound calls (37.5%, 51/136) were related to the pill status icon on the software application. The majority (55.3%, 142/257) of outbound calls were related to issues with the patch. Mean patch wear was 78% and mean ingestion adherence was 89% (in the days with good patch coverage) for all patients over the course of the study.

Conclusions: The results build on the utility of a DMS to objectively measure adherence in clinical practice suggesting that proactive calls to patients who do not have pill ingestion registered may be helpful in remediating issues with use of the patch.

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