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Purpose Symptoms of psychotic disorders can complicate efforts to accurately evaluate patients’ medication ingestion. The digital medicine system (DMS), composed of antipsychotic medication co-encapsulated with an ingestible sensor, wearable sensor patches, and a smartphone application, was developed to objectively measure medication ingestion. We assessed performance and acceptance of the DMS in subjects with psychotic disorders. Methods This was an 8-week open-label, single-arm, multicenter, Phase 4 pragmatic study (NCT 03568500; EudraCT #2017-004602-17). Eligible adults were diagnosed with schizophrenia, schizoaffective disorder, or first-episode psychosis; were receiving aripiprazole, quetiapine, olanzapine, or risperidone; and could use the DMS with the application downloaded on a personal smartphone. The primary endpoint was good patch coverage, defined as the proportion of days over the assessment period where ≥80.0% of patch data was available, or an ingestion was detected. Exploratory endpoints included a survey on user satisfaction, used to assess acceptance of the DMS. Safety analyses included the incidence of treatment-emergent adverse events (TEAEs). Results From May 25, 2018 to March 22, 2019, 55 subjects were screened and 44 were enrolled. Good patch coverage was achieved on 63.4% of days assessed and the DMS generated an adherence metric of ≥80.0%, reflecting the percentage of ingestion events expected when good patch coverage was reported. Most subjects (53.5%) were satisfied with the DMS. Medical device skin irritations were the only TEAEs reported. Conclusion The DMS had sufficient performance in, and acceptance from, subjects with psychotic disorders and was generally well tolerated.

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Objective: Adding to existing challenges in conducting clinical trials, COVID-19 has indefinitely affected modern clinical research. Decentralized clinical trials, using telemedicine and digital technology, may prove critical to the future of clinical development. This type of methodology in psychiatric trials remains largely unexplored; therefore, we evaluated the feasibility and quality of data collection in a randomized, sham-interventional trial using fully decentralized methodology in subjects with major depressive disorder (MDD). Methods: This was a four-week, noninterventional, two-cohort, decentralized, clinical trial. Eligible adults had a diagnosis of MDD and were medically stable. Subjects in cohort 1 continued stable antidepressant and antipsychotic treatment and were randomly assigned 1:1 into assisted or unassisted groups (ie, completing assessments at home aided by mobile healthcare providers or alone using study-provided materials, respectively). Subjects in cohort 2 continued stable antidepressant treatment only or with other therapy and could choose assignment to assisted or unassisted groups. Coprimary endpoints were operational effectiveness (assessed by completion rate, subject diversity, time to study start, and subject satisfaction) and data-collection integrity (assessed by subjects' ability to collect assessments and realtime data availability). Safety analyses included incidence of adverse events and suicidality. Results: In cohort 1, 96 subjects were screened with 31 enrolled; in cohort 2, 46 subjects were screened with 26 enrolled. Most subjects (≥81% across study groups and cohorts), and more than 80% of both cohorts, completed all assessments. No major safety concerns were encountered. Conclusions: This study demonstrated that decentralized clinical trials can be performed in patients with stable MDD. Clinical trial registration number: None; this was a noninterventional trial.