Digital medicine system may reduce schizophrenia symptoms

A digital medicine system appeared to improve clinical schizophrenia symptoms beyond the effects of oral pharmacotherapy alone, according to study results presented at Psych Congress.

“This work uses data from a digital medicine system that consists of tablets of the atypical antipsychotic aripiprazole, embedded with an ingestible event marker,” J. Corey Fowler, PhD, director of global clinical development at Otsuka Pharmaceutical Development & Commercialization Inc. in New Jersey, said during a virtual presentation. “When a pill is ingested, a signal is sent from the ingestible sensor to a wearable patch, and this ingestion record is then sent to a smartphone application via Bluetooth. The system is indicated for treating adults with schizophrenia or bipolar disorder, and as an adjunctive treatment for major depressive disorder.”

In the current post hoc analysis of data from a phase 3b clinical trial, Fowler and colleagues examined the link between patients’ engagement with the digital medicine system (DMS) and changes in clinically obtained patient performance and symptom severity measures. Participants completed the Clinical Global Impression-Severity of Illness (CGI-S) and Improvement of Illness (CGI-I) scales, Personal and Social Performance Scale (PSP) and Positive and Negative Syndrome Scale (PANSS). In the clinical trial, researchers assessed the difference between psychiatric hospitalization rates of patients who received oral standard-of-care antipsychotic treatments for 6 months. This was followed by a switch to the DMS for 3 months. At the DMS visit for the third month, investigators decided if patients would continue the DMS or switch to a standard-of-care treatment for 3 months more. Included patients were aged 18 to 65 years, had at least one psychiatric hospitalization in the past 48 months, were stable on an oral antipsychotic that was prescribed for at least 6 months and had a clinical schizophrenia diagnosis based on DSM-5 criteria.

In the post hoc analysis, Fowler and colleagues grouped patients by study completion status and an algorithm based on use of four aspects of the DMS (fraction of expected time on DMS, patch wear rate, patch-normalized ingestion rate and application log-in rate). They created three groups with various DMS engagement levels, including dropout (n = 164; patients who discontinued DMS use prior to month 3 of the study), moderate engagement (n = 63; completing the first 3 months of the study and using the DMS intermittently) and high engagement (n = 50; completing the first 3 months of the study and using the DMS consistently throughout).

Results showed a high patch-normalized ingestion rate across groups; however, means varied for the other aspects, with only the high-engagement group exhibiting high mean values for all four utilization aspects. Although some patients in the dropout group had high engagement, most used the DMS only briefly, evidenced by the low mean value for the faction of expected time on DMS.

Within groups, patients in all three groups had symptom improvement from baseline to endpoint, with the two more-engaged groups having more significant changes. Patients with high or moderate engagement had significant improvement for the CGI-S, CGI-I, PSP and Total PANSS. Dropout patients exhibited significant improvement on the CGI-S, CGI-I and Total PANSS. The researchers observed significant improvement for all PANSS subscales only among the high engagement patients. Across groups, highly engaged patients had significantly greater improvement compared with the dropout group for the CGI-S, PSP and Total PANSS. Patients with high engagement had significantly more improvement than those with moderate engagement on the Total PANSS. Those with moderate engagement had significantly more improvement than dropout patients on the CGI-I.

“Given that 88% of patients in this trial were taking a non-digital version of aripiprazole prior to this study and that improvement was correlated with greater system engagement, these clinical improvements are likely due to the use of the digital system, instead of strictly an effect of the active pharmaceutical,” Fowler said.