Bipolar I Disorder, Major Depressive Disorder, Mental Disorder, Schizophrenia
Conditions
Keywords
D-Tect patch
Brief summary
The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch.
Detailed description
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.
Interventions
DRUGPlacebo IEM tablet
Oral placebo-embedded IEM tablet.
DRUGAbilify MyCite®
Oral aripiprazole-embedded IEM tablet.
DEVICED-Tect Patch
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.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for Cohort 1: * In good general health or medically stable. * Is able and willing to participate in, and adhere to, all testing procedures, both onsite and offsite, for the entire testing. * The participant has access to a telephone for communicating with the trial personnel and for trial personnel to contact the participant. Inclusion Criteria for Cohort 2: * In good general health or medically stable. * Has confirmed diagnosis of schizophrenia, major depressive disorder, or bipolar I disorder per Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and currently prescribed and taking aripiprazole. * Is able and willing to participate in, and adhere to, all testing procedures, both onsite and offsite, for the entire testing. * Participant has access to a telephone for communicating with the trial personnel and for trial personnel to contact the participant
Exclusion criteria
for Cohort 1 and 2: * Any medical condition, treatment, or symptoms that, in the judgment of the trial clinician, could place the participant at more than the minimal risk from involvement in the testing. * Hospitalization, emergency room visit, surgery or new medical treatment within 30 days before testing begins or planned during testing. * Difficulty with or inability to swallow tablets. * Active skin infection or active dermatitis, or history of chronic inflammatory skin condition including psoriasis and chronic dermatitis (except atopic dermatitis). * The investigator will determine if any participant should be excluded from the trial based on history of, or current, alcohol abuse, drug abuse or use of illegal drugs (e.g., amphetamines or heroin). * Allergy to adhesive bandages/tapes (e.g., Band-Aids®) or latex. * Positive urine pregnancy test at screening visit (dipstick). * Participant is taking any concomitant medication that places the participant at a greater risk for skin reactions or skin sensitivity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch | At Day 1 | 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. |
| Cohort 1 and 2: Patch Detection Latency Period | At Day 1 | 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. |
| Cohort 1 and 2: Ingestion Data Transfer Latency Period | At Day 1 | 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. |
| Cohort 1 and 2: Total Detection Latency Period | At Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation | From Day 1 up to follow-up (up to Day 10) | 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. |
Countries
United States
Participant flow
Recruitment details
Participants took part in this study at a single investigative site in the United States from 26 June 2023 to 19 July 2023.
Pre-assignment details
A total of 54 participants were enrolled in this study and all participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: D-Tect Patch + Placebo-embedded IEM A D-Tect patch was applied by the clinical staff prior to the first ingestion of a placebo-embedded IEM tablet. DOIs of 15 placebo-embedded IEM tablets were noted at 15 minute intervals on Day 1. | 24 |
| Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) A D-Tect patch was applied by the clinical staff prior to the ingestion of the IEM-embedded Abilify MyCite® tablet. A DOI of a single dose of Abilify MyCite® tablet occurred on Day 1. | 30 |
| Total | 54 |
Baseline characteristics
| Characteristic | Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) | Total | Cohort 1: D-Tect Patch + Placebo-embedded IEM |
|---|---|---|---|
| Age, Continuous | 46.1 years STANDARD_DEVIATION 12.03 | 48.2 years STANDARD_DEVIATION 12.82 | 50.8 years STANDARD_DEVIATION 13.56 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 20 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 34 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 13 Participants | 12 Participants |
| Race/Ethnicity, Customized Race Black or African American | 9 Participants | 15 Participants | 6 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White | 20 Participants | 26 Participants | 6 Participants |
| Region of Enrollment United States | 30 Participants | 54 Participants | 24 Participants |
| Sex: Female, Male Female | 10 Participants | 27 Participants | 17 Participants |
| Sex: Female, Male Male | 20 Participants | 27 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 30 |
| other Total, other adverse events | 7 / 24 | 3 / 30 |
| serious Total, serious adverse events | 0 / 24 | 0 / 30 |
Outcome results
Primary
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
Population: The FAS comprised of all the detections of the wearable sensors done on the participants who took at least 1 dose of MIT (Cohort 1) or Abilify MyCite® (Cohort 2), excluding those detections with device malfunction (invalid session and bad impedance). Overall number of participants analyzed indicates the number of participants with at least one detection.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: D-Tect Patch + Placebo-embedded IEM | Cohort 1 and 2: Ingestion Data Transfer Latency Period | 17.0 seconds |
| Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) | Cohort 1 and 2: Ingestion Data Transfer Latency Period | 17.0 seconds |
Primary
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
Population: The FAS comprised of all the detections of the wearable sensors done on the participants who took at least 1 dose of MIT (Cohort 1) or Abilify MyCite® (Cohort 2), excluding those detections with device malfunction (invalid session and bad impedance). Overall number of participants analyzed indicates the number of participants with at least one detection.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: D-Tect Patch + Placebo-embedded IEM | Cohort 1 and 2: Patch Detection Latency Period | 53.0 seconds |
| Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) | Cohort 1 and 2: Patch Detection Latency Period | 312.0 seconds |
Primary
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
Population: The FAS comprised of all the detections of the wearable sensors done on the participants who took at least 1 dose of MIT (Cohort 1) or Abilify MyCite® (Cohort 2), excluding those detections with device malfunction (invalid session and bad impedance). Overall number of participants analyzed indicates the number of participants with at least one detection.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: D-Tect Patch + Placebo-embedded IEM | Cohort 1 and 2: Total Detection Latency Period | 73.0 seconds |
| Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) | Cohort 1 and 2: Total Detection Latency Period | 351.0 seconds |
Primary
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
Population: Full analysis set (FAS) comprised of all the detections of the wearable sensors done on the participants who took at least 1 dose of a miniature ingestible tablet (MIT) (Cohort 1), excluding those detections with device malfunction (invalid session and bad impedance). 'Overall number of participants analyzed' indicates the number of participants with at least one detection in Cohort 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: D-Tect Patch + Placebo-embedded IEM | Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch | 100 percentage of detections |
Secondary
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)
Population: Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: D-Tect Patch + Placebo-embedded IEM | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation | Participants With TEAEs | 7 Participants |
| Cohort 1: D-Tect Patch + Placebo-embedded IEM | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation | Participants With Device-related TEAEs | 5 Participants |
| Cohort 1: D-Tect Patch + Placebo-embedded IEM | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation | Participants With Serious TEAEs | 0 Participants |
| Cohort 1: D-Tect Patch + Placebo-embedded IEM | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation | Participants With TEAEs Leading to Study Discontinuation | 0 Participants |
| Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation | Participants With TEAEs Leading to Study Discontinuation | 0 Participants |
| Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation | Participants With TEAEs | 3 Participants |
| Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation | Participants With Serious TEAEs | 0 Participants |
| Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation | Participants With Device-related TEAEs | 3 Participants |