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 Overview
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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.

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.

Official Title
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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)

Conditions
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Schizophrenia, Schizoaffective Disorder, First Episode Psychosis

Intervention / Treatment
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* Device: Digital Medicine System
* Drug: Aripiprazole
* Drug: Olanzapine
* Drug: Quetiapine
* Drug: Risperidone


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aripiprazole<br>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. | Device: Digital Medicine System<br>* 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).<br>Drug: Aripiprazole<br>* Dosage determined by the healthcare professionals.<br>|
| Experimental: Olanzapine<br>Participants received 1 oral tablet of CoE olanzapine, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. | Device: Digital Medicine System<br>* 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).<br>Drug: Olanzapine<br>* Dosage determined by the healthcare professionals.<br>|
| Experimental: Quetiapine<br>Participants received 1 oral tablet of CoE quetiapine, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. | Device: Digital Medicine System<br>* 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).<br>Drug: Quetiapine<br>* Dosage determined by the healthcare professionals.<br>|
| Experimental: Risperidone<br>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. | Device: Digital Medicine System<br>* 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).<br>Drug: Risperidone<br>* Dosage determined by the healthcare professionals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Of Days With Good Patch Coverage | The DMS includes a drug-device combination of a CoE product, a wearable sensor patch, and application software (smartphone) to record activity and rest and mark events through the act of ingestion. The CoE product consists of an approved antipsychotic medication enclosed with an Ingestible Sensor Pill (miniature ingestible event marker in tablet [MIT]). The sensor patch detects and records each MIT ingestion, as well as other physiologic and behavioral data. Good patch coverage for a specific day was defined as having either at least 80% patch data available (80% of the day the patch was worn and data was collected as noted via the accelerometer channel) or the MIT was detected within the 24-hour period, for each day while the participant was in the trial. The percentage of days was calculated as the number of days with good patch coverage divided by the total number of trial days for each participant. Descriptive statistics were performed for this outcome measure. | Up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Adherence | The DMS includes a drug-device combination of a CoE product, a wearable sensor patch, and application software (smartphone) to record activity and rest and mark events through the act of ingestion. The CoE product consists of an approved antipsychotic medication enclosed with an Ingestible Sensor Pill (MIT). The sensor patch detects and records each MIT ingestion, as well as other physiologic and behavioral data. Participant adherence was measured as the detected MITs over the expected MITs ingested during the trial days with good patch coverage. The more the participant successfully engaged in a number of processes across the 8-week trial, the greater the measured adherence. Descriptive statistics were performed for this outcome measure. | Up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Medicine System