@article{ref1,
title="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",
journal="Journal of clinical psychiatry",
year="2022",
author="Cohen, Elan A. and Skubiak, Taisa and Hadzi Boskovic, Dusica and Norman, Keinya and Knights, Jonathan and Fang, Hui and Coppin-Renz, Antonia and Peters-Strickland, Timothy and Lindenmayer, Jean-Pierre and Reuteman-Fowler, J. Corey",
volume="83",
number="3",
pages="21m14132-21m14132",
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. <br><br>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. <br><br>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. <br><br>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.<p /><p>Language: en</p>",
language="en",
issn="0160-6689",
doi="10.4088/JCP.21m14132",
url="http://dx.doi.org/10.4088/JCP.21m14132"
}