First Episode Psychosis, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Digital Medicine System
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.
Interventions
DEVICEDigital Medicine System
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).
DRUGAripiprazole
Dosage determined by the healthcare professionals.
DRUGOlanzapine
Dosage determined by the healthcare professionals.
DRUGQuetiapine
Dosage determined by the healthcare professionals.
DRUGRisperidone
Dosage determined by the healthcare professionals.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Of Days With Good Patch Coverage | Up to 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Adherence | Up to 8 weeks | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
The trial enrolled participants with a confirmed clinical diagnosis of schizophrenia, schizoaffective disorder, or first episode psychosis.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 20 |
| 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. | 6 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 | 2 |
| Overall Study | Participant Noncompliance | 1 | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Technical Problems | 2 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Quetiapine | Aripiprazole | Olanzapine |
|---|---|---|---|---|
| Age, Continuous | 34.4 Years STANDARD_DEVIATION 10.7 | 30.8 Years STANDARD_DEVIATION 8.8 | 31.6 Years STANDARD_DEVIATION 9.6 | 38.0 Years STANDARD_DEVIATION 11.4 |
| Disease Diagnosis First Episode Psychosis | 16 Participants | 4 Participants | 9 Participants | 3 Participants |
| Disease Diagnosis Schizoaffective Disorder | 10 Participants | 2 Participants | 4 Participants | 4 Participants |
| Disease Diagnosis Schizophrenia | 18 Participants | 0 Participants | 5 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 5 Participants | 17 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 35 Participants | 6 Participants | 14 Participants | 15 Participants |
| Sex: Female, Male Female | 15 Participants | 3 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 29 Participants | 3 Participants | 10 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 19 | 0 / 6 | 0 / 43 |
| other Total, other adverse events | 4 / 18 | 2 / 19 | 3 / 6 | 9 / 43 |
| serious Total, serious adverse events | 0 / 18 | 0 / 19 | 0 / 6 | 0 / 43 |
Outcome results
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.
Time frame: Up to 8 weeks
Population: Intent-to-treat (ITT) Population: All participants who entered the trial and used the DMS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Schizophrenia | Percentage Of Days With Good Patch Coverage | 64.34 percentage of days | Standard Deviation 20.24 |
| Schizoaffective Disorder | Percentage Of Days With Good Patch Coverage | 62.99 percentage of days | Standard Deviation 37.68 |
| First Episode Psychosis | Percentage Of Days With Good Patch Coverage | 62.51 percentage of days | Standard Deviation 27.53 |
| Total | Percentage Of Days With Good Patch Coverage | 63.37 percentage of days | Standard Deviation 26.6 |
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.
Time frame: Up to 8 weeks
Population: Intent-to-treat (ITT) Population: All participants who entered the trial, used the DMS, and had data available at the specified timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Schizophrenia | Participant Adherence | 88.94 percentage of MITs | Standard Deviation 8.06 |
| Schizoaffective Disorder | Participant Adherence | 72.29 percentage of MITs | Standard Deviation 25.65 |
| First Episode Psychosis | Participant Adherence | 91.04 percentage of MITs | Standard Deviation 7.37 |
| Total | Participant Adherence | 86.57 percentage of MITs | Standard Deviation 14.47 |