Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
NCT ID: NCT02091882
Last Updated: 2021-10-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2014-03-21
2014-04-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
Participants were placed a patch by the clinical staff prior to each ingestible event marker (IEM) tablet ingestion. Participants received one IEM tablet approximately every 2 hours, for a total of 4 ingestions on Day 1 at 0, 2, 4 and 6 hours.
Following placement of the patch by clinic staff, participants ingested one 10 mg aripiprazole-embedded IEM tablet without food at Hour 0, one placebo-embedded IEM tablet without food at approximately Hour 2, one placebo-embedded IEM tablet with a high fat meal at approximately Hour 4, and one placebo-embedded IEM tablet without food at approximately Hour 6. Clinic staff recorded the time of each ingestion of an IEM and the time detected by MIND1 System.
Placebo
Oral placebo-embedded IEM tablet.
Combination product of Aripiprazole + IEM + Sensor + MIND1 Application
Combination product of aripiprazole tablet embedded with sensor and wearable patch with MIND1 system on smartphone
Interventions
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Placebo
Oral placebo-embedded IEM tablet.
Combination product of Aripiprazole + IEM + Sensor + MIND1 Application
Combination product of aripiprazole tablet embedded with sensor and wearable patch with MIND1 system on smartphone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must be in good general health (not suffering from a serious chronic mental or physical disorder that has required or may in the near future require urgent medical care)
* Body mass index between 19 to 32 kg/m\^2
* Ability to eat the high-fat meal
Exclusion Criteria
* Participants who, in the opinion of the investigator, is acutely psychotic or manic and has symptoms currently requiring hospitalization
* Participants with a history or evidence of a medical condition that would expose him or her to an undue risk of a significant adverse event (AE) or interfere with assessments of safety during the course of the trial
* Participants have received any investigational product within the last 30 days.
* Participants has a current history of drug or alcohol dependence that meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria
* Participants has the presence of cognitive impairment
* Participants currently taking antipsychotic medication
* Participants with a terminal illness
* Participants with a history of chronic dermatitis
* Participants with a history of gastrointestinal surgery that could impair absorption
* Female participants who are breastfeeding and/or who have a positive serum pregnancy test result prior to receiving trial medications
* Sexually active women of childbearing potential (WOCBP) who will not commit to using 2 forms of approved birth control methods or who will not remain abstinent during this trial and for 30 days following the last dose of trial medication
* Sexually active males who will not commit to using 2 of the approved birth control methods or who will not remain abstinent for the duration of the trial and for 90 days following the last dose of trial medication
* No permanent physical residence
* After resting for ≥3 minutes, have a sitting systolic blood pressure \<100 or ≥150 millimeters of mercury (mmHg) and/or diastolic blood pressure \<50 or ≥90 mmHg
* After resting for ≥3 minutes, have a sitting pulse rate \<35 or \>100 beats per minute
* Participants who, in the opinion of the investigator, should not participate in the trial
18 Years
65 Years
ALL
Yes
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Development & Commercialization
Locations
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Walnut Creek, California, United States
Countries
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References
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Jan M, Coppin-Renz A, West R, Gallo CL, Cochran JM, Heumen EV, Fahmy M, Reuteman-Fowler JC. Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials. JMIR Form Res. 2023 Dec 12;7:e44768. doi: 10.2196/44768.
Rohatagi S, Profit D, Hatch A, Zhao C, Docherty JP, Peters-Strickland TS. Optimization of a Digital Medicine System in Psychiatry. J Clin Psychiatry. 2016 Sep;77(9):e1101-e1107. doi: 10.4088/JCP.16m10693.
Profit D, Rohatagi S, Zhao C, Hatch A, Docherty JP, Peters-Strickland TS. Developing a Digital Medicine System in Psychiatry: Ingestion Detection Rate and Latency Period. J Clin Psychiatry. 2016 Sep;77(9):e1095-e1100. doi: 10.4088/JCP.16m10643.
Other Identifiers
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316-13-206A
Identifier Type: -
Identifier Source: org_study_id