At a glance
ClinicalIndex Comparison RecordN/ACompleted· 54 enrolled
Drug / intervention
Placebo IEM tablet +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Prospective Trial Assessing Positive Detection Accuracy and Detection Latency Measures of the Miniature Ingestible Event Marker Tablet Using the D-Tect Patch in Healthy Subjects and Assessing Detection Latency Measures Using the D-Tect Patch in Subjects With Serious Mental Illness Taking Abilify MyCite Tablet
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Apr 17, 2024·Updated Jul 31, 2024
In Brief
A clinical study evaluating Placebo IEM tablet, Abilify MyCite®, and 1 other intervention for Mental Disorder and 3 related conditions. Completed, enrolled 54 participants across 1 site.
Detailed Summary
The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
202420252026
Enrollment StartJun 2023
Primary CompletionJul 2023
First PostedApr 2024
TodayJul 2026
First PostedApr 17, 2024
Enrollment StartJun 26, 2023
Primary CompletionJul 19, 2023
TodayJul 2, 2026
Enrollment to primary: 23 daysPosted 2.2 years ago
Interventions
Placebo IEM tabletdrug
Oral placebo-embedded IEM tablet.
Abilify MyCite®drug
Oral aripiprazole-embedded IEM tablet.
D-Tect Patchdevice
The D-Tect patch is a wearable sensor (WS) capable of detecting the ingestion of the IEM and measuring physiologic parameters. The WS automatically logs and stores the time when the IEM reaches the stomach and transmits the data to a smartphone.