Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the helpfulness of the integrated call center in optimizing use of the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder taking oral aripiprazole.
The Digital Medicine System includes a drug-device combination of aripiprazole + an ingestible event marker (IEM), a wearable sensor (skin patch), and application software to convey the level of activity and rest, and to mark events through the act of ingestion.
Physician and self-report are the most commonly used to assess medication compliance yet studies have consistently found that healthcare providers' subjective judgments of medication compliance are often inaccurate, with a tendency for practitioners to overestimate subject adherence. The sponsor's intent is to develop a system that will benefit future subjects by providing the ability to measure their medication-taking behavior in an objective manner and being able to monitor several physiologic parameters.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole + IEM | Experimental | Subjects will receive an intervention consisting of a drug-device combination that consists of an aripiprazole tablet with a tiny sensor embedded within it referred to as an Ingestible Event Marker (IEM) . They will discontinue their normally prescribed oral aripiprazole tablets and will take the aripiprazole(2, 5, 10, 15, 20, or 30 mg) + IEM once daily for the 8-week assessment period for this trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole + IEM (Ingestible Event Marker) | Drug | Oral aripiprazole (2, 5, 10, 15, 20, or 30 mg) with an ingestible event marker in a single daily dose for duration of the trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the Functionality of an Integrated Call Center for DMS by Adult Subjects With SCH, MDD, or BP1 Who Were Treated With Oral Aripiprazole. | The primary outcome was assessed as the establishment of a functional and operational integrated call center with coordinated feedback to the subject and investigative site to optimize the use of DMS as measured by:
The number presented in the table is the number of subjects in trial who made (inbound) or received (outbound) calls | From baseline upto week 9 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tim Peters-Strickland, M.D. | Otsuka Pharmaceutical Development & Commercialization, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Granada Hills | California | 91344 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38085556 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The trial consisted of a screening period of ≤ 7 days. This period assessed the eligibility criteria at 1 or more visits. An interactive web response system (IWRS) was used to obtain an identification number for each subject with a signed electronic informed consent form (eICF).
This open-label, single-arm trial assessed the functionality of an integrated call center for digital medicine system (DMS) as used by adult subjects (18 to 65 years of age, inclusive, at the time of screening) with Schizophrenia (SCH), Bipolar 1 disorder (BP1), or Major depressive disorder (MDD) being treated with oral aripiprazole.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bipolar 1 Disorder (BP1) | This group consisted of the participants with acute treatment of manic and mixed episodes associated with BP1 who were being treated with oral aripiprazole. |
| FG001 | Major Depressive Disorder (MDD) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Rochester |
| New York |
| 14603 |
| United States |
| Durham | North Carolina | 27714 | United States |
| Richmond | Virginia | 23230 | United States |
This group consisted of the participants with adjunctive treatment of MDD who were being treated with oral aripiprazole.
| FG002 | Schizophrenia (SCH) | This group consisted of the participants with SCH who were being treated with oral aripiprazole. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) Sample: All subjects who entered the trial and used Digital Medicine System (DMS).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bipolar 1 Disorder (BP1) | This group consisted of the participants with acute treatment of manic and mixed episodes associated with bipolar 1 disorder who were treated with oral aripiprazole. |
| BG001 | Major Depressive Disorder (MDD) | This group consisted of the participants with adjunctive treatment of major depressive disorder who were treated with oral aripiprazole. |
| BG002 | Schizophrenia (SCH) | This group consisted of the participants with schizophrenia who were treated with oral aripiprazole. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessment of the Functionality of an Integrated Call Center for DMS by Adult Subjects With SCH, MDD, or BP1 Who Were Treated With Oral Aripiprazole. | The primary outcome was assessed as the establishment of a functional and operational integrated call center with coordinated feedback to the subject and investigative site to optimize the use of DMS as measured by:
The number presented in the table is the number of subjects in trial who made (inbound) or received (outbound) calls | Intent-to-treat (ITT) Sample: All subjects who entered the trial and used Digital Medicine System (DMS). | Posted | Number | participants | From baseline upto week 9 |
|
|
|
9 Weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bipolar 1 Disorder (BP1) | This group consisted of the participants with acute treatment of manic and mixed episodes associated with BP1 who were being treated with oral aripiprazole. | 0 | 22 | 0 | 22 | 10 | 22 |
| EG001 | Major Depressive Disorder (MDD) | This group consisted of the participants with adjunctive treatment of MDD who were being treated with oral aripiprazole. | 0 | 12 | 0 | 12 | 9 | 12 |
| EG002 | Schizophrenia (SCH) | This group consisted of the participants with SCH who were being treated with oral aripiprazole. | 0 | 15 | 0 | 15 | 1 | 15 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral Swelling | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
|
Until the information herein is released by Otsuka to the public domain, the contents of this document are Otsuka confidential information and should not be duplicated or re-distributed without prior written consent of Otsuka.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Development | Otsuka Pharmaceutical Development & Commercialization, Inc. | DT-inquiry@otsuka.jp |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
| Title | Measurements |
|---|---|
|
| Inbound, Week 2 |
|
| Inbound, Week 3 |
|
| Inbound, Week 4 |
|
| Inbound, Week 5 |
|
| Inbound, Week 6 |
|
| Inbound, Week 7 |
|
| Inbound, Week 8 |
|
| Inbound, Week >8 |
|
| Outbound, Baseline |
|
| Outbound, Week 1 |
|
| Outbound, Week 2 |
|
| Outbound, Week 3 |
|
| Outbound, Week 4 |
|
| Outbound, Week 5 |
|
| Outbound, Week 6 |
|
| Outbound, Week 7 |
|
| Outbound, Week 8 |
|
| Outbound, Week >8 |
|