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

• Status: Completed
• Trial end date: 2019-09-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Antipsychotic Agents; Aripiprazole; Olanzapine; Quetiapine Fumarate; Risperidone

Criteria

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.