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

Otsuka

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Schizoaffective Disorder; First Episode Psychosis

Treatments: Drug: Risperidone; Drug: Quetiapine; Drug: Olanzapine; Device: Digital Medicine System; Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03568500

031-201-00186

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 4 patient groups

Aripiprazole

Experimental group

Description:

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.

Treatment:

Device: Digital Medicine System

Drug: Aripiprazole

Olanzapine

Experimental group

Description:

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

Treatment:

Drug: Olanzapine

Device: Digital Medicine System

Quetiapine

Experimental group

Description:

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

Treatment:

Device: Digital Medicine System

Drug: Quetiapine

Risperidone

Experimental group

Description:

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.

Treatment:

Device: Digital Medicine System

Drug: Risperidone