Digital Medicine System
Research type
Research Study
Full title
A Multicentre, 8-week, Single-arm, Open-label, Pragmatic Trial to Explore Acceptance and Performance of Using a Digital Medicine System with Healthcare Professionals and Adult Subjects with Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic (Aripiprazole, Olanzapine, Quetiapine, or Risperidone)
IRAS ID
240068
Contact name
Shanaya Rathod
Contact email
Sponsor organisation
Otsuka Pharmaceutical
Eudract number
2017-004602-17
Duration of Study in the UK
years, 2 months, days
Research summary
The objectives of the trial are to assess acceptance and performance of an ingestible sensor (Digital Medicine System (DMS)) in patients with schizophrenia and schizophrenic disorders.
The DMS includes a drug-device combination of a CoEncapsulated (CoE) product (approved antipsychotic medication enclosed with an Ingestible Sensor Pill [IEM] in tablet [MIT]), a patch (Wearable Sensor), and an application software to convey level of activity and rest, and to mark events through the act of ingestion.
The ingestible sensor is a CE-marked class IIa medical device (CE 559373) by the BSI. The Wearable Patch a is CE marked class medical device. Only the software application is not CE-marked and that is currently undergoing review.
The participants in this pragmatic trial will receive CoE MIT and drug originator tablet of either aripiprazole, olanzapine, quetiapine, or risperidone as prescribed by their HCPs in routine clinical practice. The risk profiles of aripiprazole, olanzapine, quetiapine, and risperidone are well understood and are detailed in the approved product summary of product characteristics used as standard of care.
Participants in this trial will receive an initial introduction to the DMS, and have HCP visits at screening/baseline, Week 4, Week 8/early termination (ET), and as directed by the HCP for the duration of the subject’s participation in the trial.
The HCPs will have access to a digital medicine (DM) dashboard where notifications can be setup around medication ingestion.The participant worn patch measures physical parameters, such as activity and rest, as well as a time stamp of when the atypical antipsychotic medication combined with an ingestion sensor are taken. This data is transferred from the patch to the participants’ smartphone and to a secure cloud-based server. The participant can view the time of tablet ingestion each day (or missed/multiple doses) together with their daily duration of rest and activity and manually enter their current mood and quality of rest. In addition, the participant’s selected HCPs and selected caregivers/support persons can view this information via the cloud-based server with appropriate participant’s consent. HCPs can set up missed dose notifications to monitor any lapses in participant’s adherence.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/0128
Date of REC Opinion
5 Mar 2018
REC opinion
Further Information Favourable Opinion