Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole

• ClinicalTrials.gov Identifier: NCT02219009
• Recruitment Status: Completed
• First Posted: August 18, 2014
• Results First Posted: August 15, 2018
• Last Update Posted: August 15, 2018
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Information provided by (Responsible Party): Otsuka Pharmaceutical Development & Commercialization, Inc.

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Schizophrenia; Mental Disorder; Nervous System Diseases
• Intervention: Device: MIND1 System
• Enrollment: 67

Participant Flow

Recruitment Details	The trial was conducted in 67 participants at 6 trial sites in the United States.
Pre-assignment Details	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).

Arm/Group Title	MIND1 System (Cohort 1)	MIND 1 System (Cohort 2)
Arm/Group Description	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.	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.
Period Title: Overall Study
Started	37	30
Completed	27	22
Not Completed	10	8
Reason Not Completed
Withdrawal by Subject	5	1
Adverse Event	2	4
Lost to Follow-up	2	2
Protocol deviation	1	0
Physician Decision	0	1

Baseline Characteristics

Arm/Group Title		MIND1 System (Cohort 1)	MIND 1 System (Cohort 2)	Total
Arm/Group Description		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.	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 of all reporting groups
Overall Number of Baseline Participants		37	30	67
Baseline Analysis Population Description		Enrolled sample - all participants who signed an informed consent and entered the trial.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	37 participants	30 participants	67 participants
		45.8 (10.3)	47.6 (8.9)	46.6 (9.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	37 participants	30 participants	67 participants
	Female	10 27.0%	7 23.3%	17 25.4%
	Male	27 73.0%	23 76.7%	50 74.6%

Outcome Measures

1. Primary Outcome

Title	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)
Description	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.
Time Frame	Baseline to Week 8

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population - all participants who entered the trial and used the MIND1 system

Arm/Group Title	MIND1 System (Cohort 1)	MIND 1 System (Cohort 2)
Arm/Group Description:	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.	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 Number of Participants Analyzed	37	30
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	54.1; (36.9 to 70.5)	56.7; (37.4 to 74.5)

2. Secondary Outcome

Title	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.
Description	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.
Time Frame	Baseline to Week 8

Outcome Measure Data

Analysis Population Description

ITT population - all participants who entered the trial and used the MIND1 system.

Arm/Group Title	MIND1 System (Cohort 1)	MIND 1 System (Cohort 2)
Arm/Group Description:	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.	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 Number of Participants Analyzed	37	30
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	83.8; (68.0 to 93.8)	80.0; (61.4 to 92.3)

3. Secondary Outcome

Title	Proportion of Time During the Study Period When Participants Wear Their Patches
Description	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.
Time Frame	Baseline to Week 8

Outcome Measure Data

Analysis Population Description

ITT population - all participants who entered the trial and used the MIND1 system.

Arm/Group Title	MIND1 System (Cohort 1)	MIND 1 System (Cohort 2)
Arm/Group Description:	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.	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 Number of Participants Analyzed	37	30
Mean (Standard Deviation); Unit of Measure: % of time participants wore patch
	74.4 (22.0)	66.2 (27.5)

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	MIND1 System (Cohort 1)	MIND 1 System (Cohort 2)
Arm/Group Description	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.	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.
All-Cause Mortality
	MIND1 System (Cohort 1)	MIND 1 System (Cohort 2)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	MIND1 System (Cohort 1)	MIND 1 System (Cohort 2)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	2/37 (5.41%)	0/30 (0.00%)
Nervous system disorders
Transient ischaemic attack * 1	1/37 (2.70%)	0/30 (0.00%)
Psychiatric disorders
Agitation * 1	1/37 (2.70%)	0/30 (0.00%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 17.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	MIND1 System (Cohort 1)	MIND 1 System (Cohort 2)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	17/37 (45.95%)	10/30 (33.33%)
Infections and infestations
Upper respiratory tract infection * 1	3/37 (8.11%)	0/30 (0.00%)
Metabolism and nutrition disorders
Increased appetitie * 1	0/37 (0.00%)	2/30 (6.67%)
Nervous system disorders
Somnolence * 1	0/37 (0.00%)	2/30 (6.67%)
Skin and subcutaneous tissue disorders
Dermatitis contact * 1	2/37 (5.41%)	1/30 (3.33%)
Erythema * 1	2/37 (5.41%)	2/30 (6.67%)
Pruritus * 1	5/37 (13.51%)	4/30 (13.33%)
Rash * 1	3/37 (8.11%)	0/30 (0.00%)
Rash erythematous * 1	2/37 (5.41%)	0/30 (0.00%)
Vascular disorders
Hypertension * 1	3/37 (8.11%)	0/30 (0.00%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 17.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
• Phone: 800 562-3974

• Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
• ClinicalTrials.gov Identifier: NCT02219009
• Other Study ID Numbers: 316-14-220
• First Submitted: August 14, 2014
• First Posted: August 18, 2014
• Results First Submitted: July 16, 2018
• Results First Posted: August 15, 2018
• Last Update Posted: August 15, 2018