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
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Mental Disorder Nervous System Diseases||Device: MIND1 System||Phase 2|
Poor adherence to medication is a well-recognized problem in psychiatric patients. Although a variety of treatment models have been developed to improve management of patients in general and medication adherence in particular, poor medication adherence remains a major barrier to achieving optimal health.
The MIND1 System includes a drug-device combination, a patch, and application software to convey level of activity and rest and to mark events through the act of ingestion.
The purpose of this open-label study is to determine the usability of the Medical Information Device #1 (MIND1) System in adults with schizophrenia. Approximately 32 subjects with schizophrenia, between 18 and 65 years of age (inclusive) who are currently prescribed and stabilized on oral aripiprazole, will be enrolled.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, 8-week, Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adult Subjects With Schizophrenia Who Are Treated With Oral Aripiprazole|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
|Experimental: MIND1 System||
Device: MIND1 System
Subjects will receive aripiprazole tablets embedded with an IEM. They will discontinue their normally prescribed oral aripiprazole tablets and will take the aripiprazole + IEM tablets (eg, at the previously prescribed dose) during the 8-week treatment period for this study. Aripiprazole + IEM tablets must be taken on a once-daily dosing schedule.
Other Name: OPC-14597 Digital
- 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) [ Time Frame: Baseline to Week 8 ]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.
- 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. [ Time Frame: Baseline to Week 8 ]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.
- Proportion of Time During the Study Period When Participants Wear Their Patches [ Time Frame: Baseline to Week 8 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219009
|United States, California|
|Cerritos, California, United States, 90703|
|Garden Grove, California, United States, 92845|
|Oceanside, California, United States, 92056|
|United States, Georgia|
|Atlanta, Georgia, United States, 30331|
|United States, Illinois|
|Chicago, Illinois, United States, 60640|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63141|
|Study Director:||Timothy Peters-Strickland, MD||Otsuka Pharmaceutical Development & Commercialization, Inc.|