Trial Outcomes & Findings for 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 (NCT NCT03568500)
NCT ID: NCT03568500
Last Updated: 2020-07-16
Results Overview
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.
COMPLETED
PHASE4
44 participants
Up to 8 weeks
2020-07-16
Participant Flow
The trial enrolled participants with a confirmed clinical diagnosis of schizophrenia, schizoaffective disorder, or first episode psychosis.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
6
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
18
|
19
|
6
|
|
Overall Study
COMPLETED
|
8
|
14
|
2
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
|
Overall Study
Adverse Event
|
1
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
0
|
|
Overall Study
Technical Problems
|
2
|
1
|
0
|
|
Overall Study
Participant Noncompliance
|
1
|
1
|
0
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Aripiprazole
n=18 Participants
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.
|
Olanzapine
n=20 Participants
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.
|
Quetiapine
n=6 Participants
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.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.6 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
38.0 Years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
30.8 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
34.4 Years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Disease Diagnosis
Schizophrenia
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Disease Diagnosis
Schizoaffective Disorder
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Disease Diagnosis
First Episode Psychosis
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Intent-to-treat (ITT) Population: All participants who entered the trial and used the DMS.
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.
Outcome measures
| Measure |
Schizophrenia
n=18 Participants
Participants had a confirmed clinical diagnosis of schizophrenia (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 healthcare professional.
|
Schizoaffective Disorder
n=9 Participants
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 healthcare professional.
|
First Episode Psychosis
n=16 Participants
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 healthcare professional.
|
Total
n=43 Participants
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.
|
|---|---|---|---|---|
|
Percentage Of Days With Good Patch Coverage
|
64.34 percentage of days
Standard Deviation 20.24
|
62.99 percentage of days
Standard Deviation 37.68
|
62.51 percentage of days
Standard Deviation 27.53
|
63.37 percentage of days
Standard Deviation 26.60
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: Intent-to-treat (ITT) Population: All participants who entered the trial, used the DMS, and had data available at the specified timepoint.
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.
Outcome measures
| Measure |
Schizophrenia
n=18 Participants
Participants had a confirmed clinical diagnosis of schizophrenia (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 healthcare professional.
|
Schizoaffective Disorder
n=8 Participants
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 healthcare professional.
|
First Episode Psychosis
n=16 Participants
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 healthcare professional.
|
Total
n=42 Participants
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.
|
|---|---|---|---|---|
|
Participant Adherence
|
88.94 percentage of MITs
Standard Deviation 8.06
|
72.29 percentage of MITs
Standard Deviation 25.65
|
91.04 percentage of MITs
Standard Deviation 7.37
|
86.57 percentage of MITs
Standard Deviation 14.47
|
Adverse Events
Aripiprazole
Olanzapine
Quetiapine
Total
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aripiprazole
n=18 participants at risk
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.
|
Olanzapine
n=19 participants at risk
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.
|
Quetiapine
n=6 participants at risk
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.
|
Total
n=43 participants at risk
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.
|
|---|---|---|---|---|
|
General disorders
Medical device site irritation
|
22.2%
4/18 • Number of events 5 • Baseline to Week 24 (+ 7 days)
|
10.5%
2/19 • Number of events 2 • Baseline to Week 24 (+ 7 days)
|
50.0%
3/6 • Number of events 4 • Baseline to Week 24 (+ 7 days)
|
20.9%
9/43 • Number of events 11 • Baseline to Week 24 (+ 7 days)
|
Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER