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SchizophreniaPhase 4NCT03568500

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 Phase 4 study testing Digital Medicine System, Aripiprazole and Olanzapine in people with Schizophrenia and Schizoaffective Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 5 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Digital Medicine System, Aripiprazole and Olanzapine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
5 sitesUnited Kingdom
Study dates
21 May 2018to 6 Sep 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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 locations and contacts

5 sites in 1 country.

5 sites in 1 country

United Kingdom5 sites

  • Clinical Trial Site

    Chertsey

  • Clinical Trial Site

    London

  • Clinical Trial Site

    Newcastle upon Tyne

  • Clinical Trial Site

    Oxford

  • Clinical Trial Site

    Southampton

Other trials in United Kingdom

About this study

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)

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.

Read the 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.

Being tested
Digital Medicine System, Aripiprazole, Olanzapine, Quetiapine, Risperidone
Keywords
Digital Medicine System
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Medicine SystemDevice

    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).

  • AripiprazoleDrug

    Dosage determined by the healthcare professionals.

  • OlanzapineDrug

    Dosage determined by the healthcare professionals.

  • QuetiapineDrug

    Dosage determined by the healthcare professionals.

  • RisperidoneDrug

    Dosage determined by the healthcare professionals.

Study groups in NCT03568500
Study groupRoleWhat they receive
AripiprazoleExperimentalParticipants received 1 oral tablet of CoEncapsulated (CoE) aripiprazole, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.
Receives: Device: Digital Medicine System; Drug: Aripiprazole
OlanzapineExperimentalParticipants received 1 oral tablet of CoE olanzapine, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.
Receives: Device: Digital Medicine System; Drug: Olanzapine
QuetiapineExperimentalParticipants received 1 oral tablet of CoE quetiapine, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.
Receives: Device: Digital Medicine System; Drug: Quetiapine
RisperidoneExperimentalParticipants 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.
Receives: Device: Digital Medicine System; Drug: Risperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 8 weeks

Secondary outcomes (1)

  1. 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.

    Measured: Up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2018
  2. Study start21 May 2018
  3. Primary completion21 May 2019
  4. Study completion6 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03568500
Sponsor's protocol ID
031-201-00186
Status last verified
Jul 2020
First submitted
25 May 2018
Last updated
16 Jul 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 38085556

  • 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.

    PubMed 31253613

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Digital Medicine System, Aripiprazole and Olanzapine in people with Schizophrenia and Schizoaffective Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 5 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Of Days With Good Patch Coverage (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03568500, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.

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Clinical Trial NCT03568500 | AzTrials