NCT03568500

A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Digital medicine systems (DMS) have been designed to assist individuals with the management of their daily health, wellness, and medication use. The DMS is being developed as a healthcare management tool to precisely measure medication adherence and to potentially enhance adherence.

Detailed description

The advancements in the treatment of mental health patients with DMS will enable healthcare professionals to assess suboptimal adherence and make more informed treatment decisions. In addition to these improvements, it will also provide a platform for engagement between participants, healthcare professionals, and caregivers/support persons. Participants who entered the trial were treated with one of the oral atypical antipsychotics defined in the trial (aripiprazole, olanzapine, quetiapine, or risperidone \[though no participant took risperidone in this trial\]). The treatment medication decision was determined by the healthcare professionals.

Conditions

• Schizophrenia
• Schizoaffective Disorder
• First Episode Psychosis

Interventions

Type	Name	Description
DEVICE	Digital Medicine System	DMS components: a CoE product consisting of an approved antipsychotic medicinal product co-encapsulated with Conformité Européenne (CE)-marked miniature ingestible event marker in tablet; a CE-marked compatible medical device (a Proteus Patch \[Disposable Wearable Sensor Version 5\]); proprietary medical software (a local and remote computing application).
DRUG	Aripiprazole	Dosage determined by the healthcare professionals.
DRUG	Olanzapine	Dosage determined by the healthcare professionals.
DRUG	Quetiapine	Dosage determined by the healthcare professionals.
DRUG	Risperidone	Dosage determined by the healthcare professionals.

Timeline

• Start date: 2018-05-21
• Primary completion: 2019-05-21
• Completion: 2019-09-06
• First posted: 2018-06-26
• Last updated: 2020-07-16
• Results posted: 2020-07-16

Locations

5 sites across 1 country: United Kingdom