Clinical trial 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
First Episode Psychosis
Keywords: Digital Medicine System
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Percentage Of Days With Good Patch Coverage
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Participant Adherence
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Chertsey
country: United Kingdom
facility: Clinical Trial Site
city: London
country: United Kingdom
facility: Clinical Trial Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Clinical Trial Site
city: Oxford
country: United Kingdom
facility: Clinical Trial Site
city: Southampton
country: United Kingdom
facility: Clinical Trial Site
Study officials:
References:
citation: Fowler JC, Cope N, Knights J, Phiri P, Makin A, Peters-Strickland T, Rathod S. Hummingbird Study: a study protocol for a multicentre exploratory trial to assess the acceptance and performance of a digital medicine system in adults with schizophrenia, schizoaffective disorder or first-episode psychosis. BMJ Open. 2019 Jun 27;9(6):e025952. doi: 10.1136/bmjopen-2018-025952.