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Original Research Focus on Psychosis April 11, 2022

Phase 3b Multicenter, Prospective, Open-label Trial to Evaluate the Effects of a Digital Medicine System on Inpatient Psychiatric Hospitalization Rates for Adults With Schizophrenia

Elan A. Cohen, PhD; Taisa Skubiak, MBA; Dusica Hadzi Boskovic, MS; Keinya Norman, MS; Jonathan Knights, PhD; Hui Fang, PhD; Antonia Coppin-Renz, MD; Timothy Peters-Strickland, MD; Jean-Pierre Lindenmayer, MD; J. Corey Reuteman-Fowler, PhD

J Clin Psychiatry 2022;83(3):21m14132

ABSTRACT

Objective: Inpatient psychiatric admissions drive the financial burden of schizophrenia, and medication adherence remains challenging. We assessed whether aripiprazole tablets with sensor (AS; system includes ingestible event-marker sensor, wearable sensor patches, and smartphone application) could reduce psychiatric hospitalizations compared with oral standard-of-care (SOC) antipsychotics.

Methods: This phase 3b, mirror-image clinical trial was conducted from April 29, 2019–August 11, 2020, in adults with schizophrenia with ≥ 1 hospitalization in the previous 48 months who had been prescribed oral SOC for the preceding 6 months (retrospective phase). All participants used AS for at least 3 months and up to 6 months. Primary endpoint was the inpatient psychiatric hospitalization rate in the modified intent-to-treat (mITT; n = 113) population during prospective months 1–3 versus retrospective phase. Proportion of days covered by medication was the secondary endpoint. Safety endpoints included adverse events related to the medication or patch and suicidality.

Results: AS significantly reduced hospitalizations during prospective months 1–3 (−9.7%) and months 1–6 (–21.3% [P ≤ .001 for all comparisons]) in the mITT population versus the corresponding retrospective phase. AS use improved confirmed medication ingestion by 26.5 percentage points in prospective months 1–3 (P ≤ .001) and reduced PANSS scores. Patches were well-tolerated, and no participant reported changes in suicide risk.

Conclusions: Compared with oral SOC, AS reduced inpatient psychiatric hospitalization rates for adults with mild-to-moderate schizophrenia. The AS system may aid medication ingestion and is associated with improvements in symptoms, potentially reducing acute-care needs among patients with schizophrenia.

Trial Registration: ClinicalTrials.gov identifier: NCT03892889

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