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

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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:
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
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)
Hide 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
Arm/Group Title MIND1 System (Cohort 1) MIND 1 System (Cohort 2) Total
Hide 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
Hide 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%
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)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
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)
Hide 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   --/--   --/-- 
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Layout table for additonal information
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