Phase 4
Completed N=30
Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
Device Latency
Source: ClinicalTrials.gov NCT02091882 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection — 73.3; 63.3; 76.7; 93.3 percentage of participants
◆ Published Evidence
Established
32citations · ~3 / year
Optimization of a Digital Medicine System in Psychiatry.
Summary
The purpose of this study was to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
Linked Publications (3)
-
Optimization of a Digital Medicine System in Psychiatry.
-
Developing a Digital Medicine System in Psychiatry: Ingestion Detection Rate and Latency Period.
-
Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection |
73.3; 63.3; 76.7; 93.3 | — |
| SECONDARY Latency Period From Ingestion to Detection of IEM |
4; 1; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy males or healthy non-pregnant females 18 to 65 years of age at the time of informed consent who are willing to either practice abstinence or 2 barrier methods of birth control or 1 barrier method and an oral contraceptive method
- 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 with a history of skin sensitivity to adhesive medical tape or metals
- 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 beats per minute
- Participants who, in the opinion of the investigator, should not participate in the trial
Data sourced from ClinicalTrials.gov (NCT02091882) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.