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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 21, 2018

Primary Completion Date

May 21, 2019

Study Completion Date

September 6, 2019

Conditions

SchizophreniaSchizoaffective DisorderFirst Episode Psychosis

Interventions

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.

Trial Locations (5)

Unknown

Clinical Trial Site, Chertsey

Clinical Trial Site, London

Clinical Trial Site, Newcastle upon Tyne

Clinical Trial Site, Oxford

Clinical Trial Site, Southampton

All Listed Sponsors

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY