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
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Study Type | Interventional |
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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) |
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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 | |
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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 | |
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Enrolled sample - all participants who signed an informed consent and entered the trial.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 37 participants | 30 participants | 67 participants | |
Female |
10 27.0%
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7 23.3%
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17 25.4%
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Male |
27 73.0%
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23 76.7%
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50 74.6%
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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 |