An interventional study of Placebo IEM tablet and Abilify MyCite® in Mental Disorder, Schizophrenia and Major Depressive Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Not applicable, Interventional, and Other
The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch.
This is an open-label study to determine the accuracy of ingestible event marker (IEM) detection and detection latency of the D-Tect patch by completing a series of patch applications and IEM ingestions in the clinic.
The participants were enrolled in two cohorts within this study- Cohort 1: healthy participants received the placebo-embedded IEM tablets, Cohort 2: participants with serious mental illness (SMI) i.e schizophrenia, major depressive disorder, or bipolar I disorder received Abilify MyCite® tablets (aripiprazole-embedded IEM tablets).
This single-center trial was conducted in the United States. The overall time to participate in this study is up to approximately 17 days.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 54 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Cohort 1:
Inclusion Criteria for Cohort 2:
Exclusion Criteria for Cohort 1 and 2:
A D-Tect patch was applied by the clinical staff prior to each IEM tablet ingestion, and directly observed ingestions (DOIs), followed by ingestion of 15 placebo-embedded IEM tablets, 1 every 15 minutes in Cohort 1 on Day 1 and a single dose of Abilify MyCite® tablet in Cohort 2 on Day 1.
Drug: Placebo IEM tablet · Drug: Abilify MyCite® · Device: D-Tect Patch
Oral placebo-embedded IEM tablet.
Oral aripiprazole-embedded IEM tablet.
Also known as: OPC-14597 Digital
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.
Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch
The PDA is calculated as the number of total positive detections by patch divided by the number of the total DOIs. PDA was estimated by Clopper-Pearson method.
Time frame: At Day 1
Cohort 1 and 2: Patch Detection Latency Period
The patch detection latency period is defined as the time between the ingestion of the tablet and the detection of the tablet ingestion by the patch. Kaplan Meier estimation was used to measure the patch detection latency period.
Time frame: At Day 1
Cohort 1 and 2: Ingestion Data Transfer Latency Period
The ingestion data transfer latency period is measured as the time between the detection of the tablet ingestion by the patch and the display of ingestion data on the mobile device. Kaplan Meier estimation was used to measure the ingestion data transfer latency period.
Time frame: At Day 1
Cohort 1 and 2: Total Detection Latency Period
The total detection latency is measured as the total time between the ingestion of the tablet and the display of ingestion data on the mobile device. Kaplan Meier estimation was used to measure the total detection the latency period.
Time frame: At Day 1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation
TEAEs were defined as AEs that occurred on or after the participant wears any patch or takes any tablet from the study at test day, and the AEs that occurred before the participant wears any patch or takes any tablet and are worsening, serious, related, or resulted in death, discontinuation, or interruption of investigational product. A serious TEAE was defined as a TEAE that is fatal, life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, or requires inpatient hospitalization or prolongation of existing hospitalization.
Time frame: From Day 1 up to follow-up (up to Day 10)
Participants took part in this study at a single investigative site in the United States from 26 June 2023 to 19 July 2023.
| Milestone | Cohort 1: D-Tect Patch + Placebo-embedded IEM | Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) |
|---|---|---|
| Started | 24 | 30 |
| Completed | 24 | 30 |
| Not completed | 0 | 0 |
The PDA is calculated as the number of total positive detections by patch divided by the number of the total DOIs. PDA was estimated by Clopper-Pearson method.
| percentage of detections | Cohort 1: D-Tect Patch + Placebo-embedded IEM |
|---|---|
| Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch | 100 (98.97 to 100) |
The patch detection latency period is defined as the time between the ingestion of the tablet and the detection of the tablet ingestion by the patch. Kaplan Meier estimation was used to measure the patch detection latency period.
| seconds | Cohort 1: D-Tect Patch + Placebo-embedded IEM | Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) |
|---|---|---|
| Cohort 1 and 2: Patch Detection Latency Period | 53.0 (11 to 206) | 312.0 (90 to 695) |
The ingestion data transfer latency period is measured as the time between the detection of the tablet ingestion by the patch and the display of ingestion data on the mobile device. Kaplan Meier estimation was used to measure the ingestion data transfer latency period.
| seconds | Cohort 1: D-Tect Patch + Placebo-embedded IEM | Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) |
|---|---|---|
| Cohort 1 and 2: Ingestion Data Transfer Latency Period | 17.0 (0 to 536) | 17.0 (6 to 145) |
The total detection latency is measured as the total time between the ingestion of the tablet and the display of ingestion data on the mobile device. Kaplan Meier estimation was used to measure the total detection the latency period.
| seconds | Cohort 1: D-Tect Patch + Placebo-embedded IEM | Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) |
|---|---|---|
| Cohort 1 and 2: Total Detection Latency Period | 73.0 (11 to 587) | 351.0 (107 to 729) |
TEAEs were defined as AEs that occurred on or after the participant wears any patch or takes any tablet from the study at test day, and the AEs that occurred before the participant wears any patch or takes any tablet and are worsening, serious, related, or resulted in death, discontinuation, or interruption of investigational product. A serious TEAE was defined as a TEAE that is fatal, life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, or requires inpatient hospitalization or prolongation of existing hospitalization.
| Participants | Cohort 1: D-Tect Patch + Placebo-embedded IEM | Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) |
|---|---|---|
| Participants With TEAEs | 7 | 3 |
| Participants With Device-related TEAEs | 5 | 3 |
| Participants With Serious TEAEs | 0 | 0 |
| Participants With TEAEs Leading to Study Discontinuation | 0 | 0 |
Collected over From Day 1 up to follow-up (up to Day 10). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: D-Tect Patch + Placebo-embedded IEM | 0/24 (0%) | 0/24 (0%) | 7/24 (29.2%) |
| Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) | 0/30 (0%) | 0/30 (0%) | 3/30 (10%) |
| Event | Cohort 1: D-Tect Patch + Placebo-embedded IEM | Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) |
|---|---|---|
| Medical device site pruritusGeneral disorders | 4/24 | 2/30 |
| Medical device site irritationGeneral disorders | 1/24 | 0/30 |
| CheilitisGastrointestinal disorders | 1/24 | 0/30 |
| NauseaGastrointestinal disorders | 1/24 | 0/30 |
| HeadacheNervous system disorders | 1/24 | 0/30 |
| Medical device site erythemaGeneral disorders | 0/24 | 1/30 |
| Faeces discolouredGastrointestinal disorders | 0/24 | 1/30 |
Enrolled analysis set included all participants who signed an informed consent form (ICF) and entered the study (and only participants who met all the inclusion criteria and none of the exclusion criteria).
| Age, Continuous(years) | Cohort 1: D-Tect Patch + Placebo-embedded IEM | Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) | Total |
|---|---|---|---|
| Mean | 50.8 ± 13.56 | 46.1 ± 12.03 | 48.2 ± 12.82 |
| Sex: Female, Male(Participants) | Cohort 1: D-Tect Patch + Placebo-embedded IEM | Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) | Total |
|---|---|---|---|
| Female | 17 | 10 | 27 |
| Male | 7 | 20 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1: D-Tect Patch + Placebo-embedded IEM | Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 16 | 20 |
| Not Hispanic or Latino | 20 | 14 | 34 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Cohort 1: D-Tect Patch + Placebo-embedded IEM | Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) | Total |
|---|---|---|---|
| Race — American Indian or Alaska Native | 0 | 0 | 0 |
| Race — Asian | 12 | 1 | 13 |
| Race — Black or African American | 6 | 9 | 15 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Race — White | 6 | 20 | 26 |
| Race — Other | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Cohort 1: D-Tect Patch + Placebo-embedded IEM | Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) | Total |
|---|---|---|---|
| United States | 24 | 30 | 54 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Otsuka Pharmaceutical Development & Commercialization, Inc.