Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)

NCT02091882 ↗

Phase 4 Completed 30 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2014-03-21
Primary completion: 2014-04-18
Completion: 2014-04-18

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Aripiprazole	Other / unclassified	10 mg	Oral

Indications

No indication recorded.