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
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)
1 other identifier
interventional
44
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 schizophrenia
Started May 2018
Shorter than P25 for phase_4 schizophrenia
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2018
CompletedFirst Submitted
Initial submission to the registry
May 25, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2019
CompletedResults Posted
Study results publicly available
July 16, 2020
CompletedJuly 16, 2020
July 1, 2020
1 year
May 25, 2018
April 30, 2020
July 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Participant Adherence
Up to 8 weeks
Study Arms (4)
Aripiprazole
EXPERIMENTALParticipants received 1 oral tablet of CoEncapsulated (CoE) aripiprazole, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.
Olanzapine
EXPERIMENTALParticipants received 1 oral tablet of CoE olanzapine, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.
Quetiapine
EXPERIMENTALParticipants received 1 oral tablet of CoE quetiapine, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.
Risperidone
EXPERIMENTALParticipants 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Clinical Trial Site
Chertsey, United Kingdom
Clinical Trial Site
London, United Kingdom
Clinical Trial Site
Newcastle upon Tyne, United Kingdom
Clinical Trial Site
Oxford, United Kingdom
Clinical Trial Site
Southampton, United Kingdom
Related Publications (2)
Jan M, Coppin-Renz A, West R, Gallo CL, Cochran JM, Heumen EV, Fahmy M, Reuteman-Fowler JC. Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials. JMIR Form Res. 2023 Dec 12;7:e44768. doi: 10.2196/44768.
PMID: 38085556DERIVEDFowler 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.
PMID: 31253613DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Development
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2018
First Posted
June 26, 2018
Study Start
May 21, 2018
Primary Completion
May 21, 2019
Study Completion
September 6, 2019
Last Updated
July 16, 2020
Results First Posted
July 16, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
- Access Criteria
- Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.