Hummingbird Study: Results from an Exploratory Trial Assessing the Performance and Acceptance of a Digital Medicine System in Adults with Schizophrenia, Schizoaffective Disorder, or First-Episode Psychosis

Abstract

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.

Healthcare Provider Engagement with a Novel Dashboard for Tracking Medication Ingestion: Impact on Treatment Decisions and Clinical Assessments for Adults with Schizophrenia

“…35,44 For example, a 2021 study of a digital antipsychotic medication reported 63.4% of study days with good sensor patch coverage, detected 56.4% of ingestible event-markers, generated an adherence metric of 86.6%, and was considered satisfactory and helpful by a majority of patients with SMI. 45 A recent, phase 3b, mirror-image, open-label, single-arm clinical trial compared outcomes for patients with schizophrenia who had a history of psychiatric hospitalization when they used standard-of-care (SOC) oral antipsychotics versus when they used ABILIFY MYCITE ® (aripiprazole tablets with sensor [AS]). 46 AS consists of aripiprazole tablets embedded with an ingestible event-marker sensor, wearable sensor patches and a smartphone application, and is indicated for the treatment of adults with schizophrenia or bipolar I disorder, and as adjunct treatment for adults with major depressive disorder.…”

“… 35 , 44 For example, a 2021 study of a digital antipsychotic medication reported 63.4% of study days with good sensor patch coverage, detected 56.4% of ingestible event-markers, generated an adherence metric of 86.6%, and was considered satisfactory and helpful by a majority of patients with SMI. 45 …”

Use of an Ingestible, Sensor-Based Digital Adherence System to Strengthen the Therapeutic Relationship in Serious Mental Illness

“…Abilify iDAS is intended to augment treatment as usual by a physician, a model incorporated into the MindLAMP [34] and Horyzons platforms [35]. Abilify iDAS and these platforms have consistently demonstrated feasibility of use and efficacy with treatment as usual in psychiatric patients with SMI [34,[36][37][38][39][40][41]. These reports substantiate the proposal that Abilify iDAS could support the TR.…”

Digital Medicine System in Veterans With Severe Mental Illness: Feasibility and Acceptability Study

“…Patients were asked to use the DMS for 90 days, at which time they, along with their provider, could decide whether to continue using the DMS beyond 90 days and up to the full 12 months of study participation. Compared with previous studies using a DMS with an ingestible sensor pill for a period of 8 [13] or 12 [14] weeks, the use of the DMS lasted up to 12 months, which provided insight into DMS use that was 90 days or longer (12/21, 57%), with 29% (6/21) of respondents opting to use the DMS for 180 days or more.…”

“…In another trial using the same DMS [13] as in our study, adherence was measured by the proportion of days with good DMS patch coverage (ingestible event marker registration). However, in our study, medication adherence was assessed by the PDC on aripiprazole using pharmacy record data.…”