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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-21

Study Completion Date

2019-09-06

Brief Summary

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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.

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Detailed Description

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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

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Schizophrenia Schizoaffective Disorder First Episode Psychosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Aripiprazole

Participants received 1 oral tablet of CoEncapsulated (CoE) aripiprazole, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.

Group Type EXPERIMENTAL

Digital Medicine System

Intervention Type DEVICE

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).

Aripiprazole

Intervention Type DRUG

Dosage determined by the healthcare professionals.

Olanzapine

Participants received 1 oral tablet of CoE olanzapine, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.

Group Type EXPERIMENTAL

Digital Medicine System

Intervention Type DEVICE

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).

Olanzapine

Intervention Type DRUG

Dosage determined by the healthcare professionals.

Quetiapine

Participants received 1 oral tablet of CoE quetiapine, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.

Group Type EXPERIMENTAL

Digital Medicine System

Intervention Type DEVICE

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).

Quetiapine

Intervention Type DRUG

Dosage determined by the healthcare professionals.

Risperidone

Participants were to receive 1 oral tablet of CoE risperidone, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. No participant took risperidone in this trial.

Group Type EXPERIMENTAL

Digital Medicine System

Intervention Type DEVICE

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).

Risperidone

Intervention Type DRUG

Dosage determined by the healthcare professionals.

Interventions

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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).

Intervention Type DEVICE

Aripiprazole

Dosage determined by the healthcare professionals.

Intervention Type DRUG

Olanzapine

Dosage determined by the healthcare professionals.

Intervention Type DRUG

Quetiapine

Dosage determined by the healthcare professionals.

Intervention Type DRUG

Risperidone

Dosage determined by the healthcare professionals.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participant was prescribed aripiprazole, olanzapine, quetiapine, or risperidone.
* Participant possessed a smartphone, or a smartphone provided by the Sponsor, and was willing to download and interact with the DMS app.
* Skin on the anterior chest just above the lower edge of the rib cage was free of any dermatological problems (for example, open wounds, warts, rashes, atopic dermatitis).

Exclusion Criteria

* Participant with a known allergy to adhesive tape or any pertinent components of the patch or CoE product.
* Prisoners could not be enrolled into this trial.
* Participant who was hospitalized due to mental or physical illness (inpatient) at the time of screening/baseline.
* Any participant who, through religious or lifestyle choices, would not take gelatin capsules.
* Female of childbearing potential who was breast-feeding and/or who had a positive pregnancy test result prior to receiving trial enrollment, or who planned to become pregnancy during the trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No