Trial Outcomes & Findings for Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole (NCT NCT02219009)
NCT ID: NCT02219009
Last Updated: 2018-08-15
Results Overview
Proportion of participants who are able to pair and apply a patch independently and successfully by the end of the Week 8 study visit (or early termination, if applicable), as defined as a score of 91 to 100 on the participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP). A participant was considered to have successfully and independently applied a patch if the SAUSS-HCP was at least 91 for at least one postbaseline score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2018-08-15
Participant Flow
The trial was conducted in 67 participants at 6 trial sites in the United States.
The trial included a screening period (≤ 2 weeks), a treatment period (8 weeks), and a safety follow-up period (2 weeks). Participants enrolled under the original version of the protocol were considered to comprise a first cohort (Cohort 1), while subjects enrolled under Amendment 1 were considered to comprise a separate second cohort (Cohort 2).
Participant milestones
| Measure |
MIND1 System (Cohort 1)
Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).
Cohort 1 participants were enrolled under the original protocol.
|
MIND 1 System (Cohort 2)
Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.
Cohort 2 participants were enrolled under protocol amendment 1.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
30
|
|
Overall Study
COMPLETED
|
27
|
22
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
| Measure |
MIND1 System (Cohort 1)
Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).
Cohort 1 participants were enrolled under the original protocol.
|
MIND 1 System (Cohort 2)
Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.
Cohort 2 participants were enrolled under protocol amendment 1.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Protocol deviation
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole
Baseline characteristics by cohort
| Measure |
MIND1 System (Cohort 1)
n=37 Participants
Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).
Cohort 1 participants were enrolled under the original protocol.
|
MIND 1 System (Cohort 2)
n=30 Participants
Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.
Cohort 2 participants were enrolled under protocol amendment 1.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
46.6 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: The intent-to-treat (ITT) population - all participants who entered the trial and used the MIND1 system
Proportion of participants who are able to pair and apply a patch independently and successfully by the end of the Week 8 study visit (or early termination, if applicable), as defined as a score of 91 to 100 on the participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP). A participant was considered to have successfully and independently applied a patch if the SAUSS-HCP was at least 91 for at least one postbaseline score.
Outcome measures
| Measure |
MIND1 System (Cohort 1)
n=37 Participants
Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).
Cohort 1 participants were enrolled under the original protocol.
|
MIND 1 System (Cohort 2)
n=30 Participants
Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.
Cohort 2 participants were enrolled under protocol amendment 1.
|
|---|---|---|
|
Proportion of Participants Who Are Able to Pair & Apply a Patch Independently & Successfully by the End of the Week 8 Study Visit as Defined by a Score of 91 to 100 on the Subject Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP)
|
54.1 percentage of participants
Interval 36.9 to 70.5
|
56.7 percentage of participants
Interval 37.4 to 74.5
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: ITT population - all participants who entered the trial and used the MIND1 system.
Proportion of participants who are able to pair and apply a patch successfully, independently, or with minimum assistance, by the end of the Week 8 study visit (or early termination, if applicable), as defined by a Participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP) score of 71 to 100. Participants were considered to have paired and applied a patch independently or with minimal assistance if their SAUSS-HCP score was at least 71 for at least one postbaseline score.
Outcome measures
| Measure |
MIND1 System (Cohort 1)
n=37 Participants
Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).
Cohort 1 participants were enrolled under the original protocol.
|
MIND 1 System (Cohort 2)
n=30 Participants
Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.
Cohort 2 participants were enrolled under protocol amendment 1.
|
|---|---|---|
|
Proportion of Participants Able to Pair & Apply a Patch Successfully, Independently, or With Minimum Assistance, by the End of the Week 8 Study Visit, as Defined by a SAUSS-HCP Score of 71 to 100.
|
83.8 percentage of participants
Interval 68.0 to 93.8
|
80.0 percentage of participants
Interval 61.4 to 92.3
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: ITT population - all participants who entered the trial and used the MIND1 system.
Proportion of time during the study period when participants wear their patches; the time duration of patch wearing will be calculated based on digital health data. Percentage of participants' patch wearing time was calculated as (total duration a patch was worn / trial duration) x 100.
Outcome measures
| Measure |
MIND1 System (Cohort 1)
n=37 Participants
Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).
Cohort 1 participants were enrolled under the original protocol.
|
MIND 1 System (Cohort 2)
n=30 Participants
Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.
Cohort 2 participants were enrolled under protocol amendment 1.
|
|---|---|---|
|
Proportion of Time During the Study Period When Participants Wear Their Patches
|
74.4 % of time participants wore patch
Standard Deviation 22.0
|
66.2 % of time participants wore patch
Standard Deviation 27.5
|
Adverse Events
MIND1 System (Cohort 1)
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
MIND 1 System (Cohort 2)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MIND1 System (Cohort 1)
n=37 participants at risk
Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).
Cohort 1 participants were enrolled under the original protocol.
|
MIND 1 System (Cohort 2)
n=30 participants at risk
Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.
Cohort 2 participants were enrolled under protocol amendment 1.
|
|---|---|---|
|
Nervous system disorders
Transient ischaemic attack
|
2.7%
1/37 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
0.00%
0/30 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
|
Psychiatric disorders
Agitation
|
2.7%
1/37 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
0.00%
0/30 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
Other adverse events
| Measure |
MIND1 System (Cohort 1)
n=37 participants at risk
Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).
Cohort 1 participants were enrolled under the original protocol.
|
MIND 1 System (Cohort 2)
n=30 participants at risk
Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.
Cohort 2 participants were enrolled under protocol amendment 1.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
8.1%
3/37 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
0.00%
0/30 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
|
Metabolism and nutrition disorders
Increased appetitie
|
0.00%
0/37 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
6.7%
2/30 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/37 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
6.7%
2/30 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.4%
2/37 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
3.3%
1/30 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.4%
2/37 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
6.7%
2/30 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.5%
5/37 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
13.3%
4/30 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.1%
3/37 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
0.00%
0/30 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
5.4%
2/37 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
0.00%
0/30 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
|
Vascular disorders
Hypertension
|
8.1%
3/37 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
0.00%
0/30 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee Center may publish study results but ≥ 60 days prior to any public presentation, a copy is sent to Sponsor for review and Center can delay publication for 60 days to permit Sponsor to protect its intellectual property rights or confidential information contained within the publication. The first publication is a joint publication, if Center is part of a multi-center study. Center is free to publish, if there is no multi-center publication within 18 months of completion/ termination of study.
- Publication restrictions are in place
Restriction type: OTHER