دورية أكاديمية
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.
| العنوان: | 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. |
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| المؤلفون: | Cohen EA; Hassman Research Institute, Marlton, New Jersey., Skubiak T; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey., Hadzi Boskovic D; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey., Norman K; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey., Knights J; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey., Fang H; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey., Coppin-Renz A; Otsuka Pharmaceutical Development & Commercialisation Europe GmbH, Hessen, Germany., Peters-Strickland T; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey., Lindenmayer JP; Nathan S. Kline Institute for Psychiatric Research, Orangeburg, New York., Reuteman-Fowler JC; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey.; Corresponding author: J. Corey Reuteman-Fowler, PhD, 38 Hewitt Rd, Lambertville, NJ 08530 (tarheel.phd@gmail.com). |
| المصدر: | The Journal of clinical psychiatry [J Clin Psychiatry] 2022 Apr 11; Vol. 83 (3). Date of Electronic Publication: 2022 Apr 11. |
| نوع المنشور: | Clinical Trial, Phase III; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Physicians Postgraduate Press Country of Publication: United States NLM ID: 7801243 Publication Model: Electronic Cited Medium: Internet ISSN: 1555-2101 (Electronic) Linking ISSN: 01606689 NLM ISO Abbreviation: J Clin Psychiatry Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Memphis, Tenn., Physicians Postgraduate Press. |
| مواضيع طبية MeSH: | Antipsychotic Agents*/adverse effects , Schizophrenia*/chemically induced , Schizophrenia*/drug therapy, Adult ; Hospitalization ; Humans ; Inpatients ; Prospective Studies ; Retrospective Studies ; Treatment Outcome |
| مستخلص: | 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. (© Copyright 2022 Physicians Postgraduate Press, Inc.) |
| التعليقات: | Comment in: J Clin Psychiatry. 2022 Apr 11;83(3):. (PMID: 35421286) |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03892889 |
| المشرفين على المادة: | 0 (Antipsychotic Agents) |
| تواريخ الأحداث: | Date Created: 20220414 Date Completed: 20220418 Latest Revision: 20220616 |
| رمز التحديث: | 20221213 |
| DOI: | 10.4088/JCP.21m14132 |
| PMID: | 35421287 |
| قاعدة البيانات: | MEDLINE |
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