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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole | Experimental | 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. |
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| Olanzapine | Experimental | Participants received 1 oral tablet of CoE olanzapine, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. |
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| Quetiapine | Experimental | Participants received 1 oral tablet of CoE quetiapine, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. |
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| Risperidone | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Medicine System | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Chertsey | United Kingdom | ||||
| Clinical Trial Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38085556 | Derived | 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. | |
| 31253613 | Derived | 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. |
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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.
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.
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.
Participants in this trial received at least 1 CoEncapsulated miniature ingestible event marker in a tablet and a medicinal product originator tablet of either aripiprazole, olanzapine, or quetiapine (participants were allowed to take risperidone, though no participant took risperidone in this trial) as prescribed by their healthcare professional.
The trial enrolled participants with a confirmed clinical diagnosis of schizophrenia, schizoaffective disorder, or first episode psychosis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole | Participants were treated with at least 1 CoEncapsulated (CoE) oral aripiprazole tablet, wearing the digital medicine system (DMS) patch, and using the associated smartphone app for a total of 8 weeks. |
| FG001 | Olanzapine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Version 1.0 | Dec 1, 2017 | Apr 13, 2020 |
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| Aripiprazole | Drug | Dosage determined by the healthcare professionals. |
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| Olanzapine | Drug | Dosage determined by the healthcare professionals. |
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| Quetiapine | Drug | Dosage determined by the healthcare professionals. |
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| Risperidone | Drug | Dosage determined by the healthcare professionals. |
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| Up to 8 weeks |
| London |
| United Kingdom |
| Clinical Trial Site | Newcastle upon Tyne | United Kingdom |
| Clinical Trial Site | Oxford | United Kingdom |
| Clinical Trial Site | Southampton | United Kingdom |
Participants were treated with at least 1 CoE oral olanzapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. |
| FG002 | Quetiapine | Participants were treated with at least 1 CoE oral quetiapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. |
| Received At Least 1 Dose of Study Drug | Safety Population: All participants who entered the trial and used the DMS. |
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| COMPLETED |
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| NOT COMPLETED |
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Enrolled Population: All participants who signed an informed consent form and entered the trial (and only participants who met all of the inclusion criteria and none of the exclusion criteria).
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | Participants were treated with at least 1 CoEncapsulated (CoE) oral aripiprazole tablet, wearing the digital medicine system (DMS) patch, and using the associated smartphone app for a total of 8 weeks. |
| BG001 | Olanzapine | Participants were treated with at least 1 CoE oral olanzapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. |
| BG002 | Quetiapine | Participants were treated with at least 1 CoE oral quetiapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Disease Diagnosis | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-treat (ITT) Population: All participants who entered the trial and used the DMS. | Posted | Mean | Standard Deviation | percentage of days | Up to 8 weeks |
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| Secondary | 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. | Intent-to-treat (ITT) Population: All participants who entered the trial, used the DMS, and had data available at the specified timepoint. | Posted | Mean | Standard Deviation | percentage of MITs | Up to 8 weeks |
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Baseline to Week 24 (+ 7 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aripiprazole | Participants were treated with at least 1 CoEncapsulated (CoE) oral aripiprazole tablet, wearing the digital medicine system (DMS) patch, and using the associated smartphone app for a total of 8 weeks. | 0 | 18 | 0 | 18 | 4 | 18 |
| EG001 | Olanzapine | Participants were treated with at least 1 CoE oral olanzapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. | 0 | 19 | 0 | 19 | 2 | 19 |
| EG002 | Quetiapine | Participants were treated with at least 1 CoE oral quetiapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | Total | Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the healthcare professional. | 0 | 43 | 0 | 43 | 9 | 43 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical device site irritation | General disorders | MedDra 22.0 | Systematic Assessment |
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Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Development | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1-609-524-6788 | clinicaltransparency@otsuka-us.com |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Version 2.0 | Jan 4, 2019 | Apr 13, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2019 | Apr 13, 2020 | SAP_002.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| D000077152 | Olanzapine |
| D000069348 | Quetiapine Fumarate |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Schizoaffective Disorder |
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| First Episode Psychosis |
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Participants had a confirmed clinical diagnosis of schizoaffective disorder (defined by International Classification of Disease-10 codes F20 and F25). There was no limit on the duration of illness. Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the HCP. |
| OG002 | First Episode Psychosis | Participants had a confirmed clinical diagnosis of first episode psychosis using case note review. The duration of illness was defined as less than 3 years since presentation to the mental health team or first antipsychotic prescription. Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the HCP. |
| OG003 | Total | Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the healthcare professional. |
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