Bipolar I Disorder, Major Depressive Disorder, Schizophrenia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGAripiprazole + IEM (Ingestible Event Marker)
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.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Primary diagnosis of Schizophrenia (SCH), Major Depressive Disorder (MDD), or Bipolar 1 Disorder (BP1), per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) * Must be able to swallow tablets * Currently taking a stable daily dose of oral aripiprazole * Must have capacity to utilize the technology * Skin in area of patch application must be free of any skin disorders or dermatological problems
Exclusion criteria
* Subjects using long acting injectable antipsychotic medications * Subjects likely to be incapable of using the Digital Medicine System even with assistance * Subjects who present serious risk of suicide * History of epilepsy or seizures * History of hypersensitivity to antipsychotic agents, adhesive tape or any component of the sensor skin patch or ingestible event marker * Current history of substance use disorder meeting DSM-5 criteria * Subject with unstable mood, acute psychosis or exhibiting symptoms requiring hospitalization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From baseline upto week 9 | 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: 1. Inbound calls (ie, calls from the subject to the integrated call center) by help type; 2. Outbound calls (ie, calls from the integrated call center to the subject) by help type. The number presented in the table is the number of subjects in trial who made (inbound) or received (outbound) calls |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Major Depressive Disorder (MDD) This group consisted of the participants with adjunctive treatment of major depressive disorder who were treated with oral aripiprazole. | 12 |
| Schizophrenia (SCH) This group consisted of the participants with schizophrenia who were treated with oral aripiprazole. | 15 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Non-adherence of the patch to the skin | 0 | 0 | 2 |
| Overall Study | Non-compliance with patch wearing | 2 | 1 | 1 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Bipolar 1 Disorder (BP1) | Major Depressive Disorder (MDD) | Schizophrenia (SCH) | Total |
|---|---|---|---|---|
| Age, Continuous | 45.5 years STANDARD_DEVIATION 15.2 | 49.3 years STANDARD_DEVIATION 11.2 | 45.5 years STANDARD_DEVIATION 11.1 | 46.4 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 15 Participants | 7 Participants | 9 Participants | 31 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 6 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 12 | 0 / 15 |
| other Total, other adverse events | 10 / 22 | 9 / 12 | 1 / 15 |
| serious Total, serious adverse events | 0 / 22 | 0 / 12 | 0 / 15 |
Outcome results
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: 1. Inbound calls (ie, calls from the subject to the integrated call center) by help type; 2. Outbound calls (ie, calls from the integrated call center to the subject) by help type. The number presented in the table is the number of subjects in trial who made (inbound) or received (outbound) calls
Time frame: From baseline upto week 9
Population: Intent-to-treat (ITT) Sample: All subjects who entered the trial and used Digital Medicine System (DMS).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bipolar 1 Disorder (BP1) | 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. | Outbound, Week 5 | 5 participants |
| Bipolar 1 Disorder (BP1) | 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. | Inbound, Week 6 | 0 participants |
| Bipolar 1 Disorder (BP1) | 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. | Outbound, Week 4 | 6 participants |
| Bipolar 1 Disorder (BP1) | 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. | Inbound, Week 4 | 4 participants |
| Bipolar 1 Disorder (BP1) | 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. | Inbound, Week 7 | 1 participants |
| Bipolar 1 Disorder (BP1) | 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. | Outbound, Week 8 | 7 participants |
| Bipolar 1 Disorder (BP1) | 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. | Inbound, Week 1 | 8 participants |
| Bipolar 1 Disorder (BP1) | 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. | Inbound, Week 8 | 2 participants |
| Bipolar 1 Disorder (BP1) | 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. | Outbound, Week 6 | 7 participants |
| Bipolar 1 Disorder (BP1) | 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. | Inbound, Week >8 | 0 participants |
| Bipolar 1 Disorder (BP1) | 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. | Inbound, Week 5 | 4 participants |
| Bipolar 1 Disorder (BP1) | 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. | Outbound, Week 3 | 6 participants |
| Bipolar 1 Disorder (BP1) | 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. | Outbound, Baseline | 0 participants |
| Bipolar 1 Disorder (BP1) | 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. | Outbound, Week >8 | 4 participants |
| Bipolar 1 Disorder (BP1) | 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. | Inbound, Week 2 | 7 participants |
| Bipolar 1 Disorder (BP1) | 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. | Outbound, Week 1 | 22 participants |
| Bipolar 1 Disorder (BP1) | 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. | Inbound, Baseline | 0 participants |
| Bipolar 1 Disorder (BP1) | 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. | Inbound, Week 3 | 2 participants |
| Bipolar 1 Disorder (BP1) | 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. | Outbound, Week 2 | 22 participants |
| Bipolar 1 Disorder (BP1) | 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. | Outbound, Week 7 | 9 participants |
| Major Depressive Disorder (MDD) | 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. | Outbound, Week 2 | 12 participants |
| Major Depressive Disorder (MDD) | 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. | Outbound, Week 3 | 4 participants |
| Major Depressive Disorder (MDD) | 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. | Inbound, Week 3 | 1 participants |
| Major Depressive Disorder (MDD) | 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. | Outbound, Week 4 | 3 participants |
| Major Depressive Disorder (MDD) | 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. | Outbound, Week 5 | 3 participants |
| Major Depressive Disorder (MDD) | 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. | Outbound, Week 6 | 2 participants |
| Major Depressive Disorder (MDD) | 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. | Inbound, Week 4 | 2 participants |
| Major Depressive Disorder (MDD) | 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. | Outbound, Week 7 | 4 participants |
| Major Depressive Disorder (MDD) | 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. | Inbound, Baseline | 0 participants |
| Major Depressive Disorder (MDD) | 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. | Outbound, Week 8 | 5 participants |
| Major Depressive Disorder (MDD) | 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. | Outbound, Week >8 | 2 participants |
| Major Depressive Disorder (MDD) | 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. | Inbound, Week 5 | 2 participants |
| Major Depressive Disorder (MDD) | 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. | Inbound, Week 6 | 3 participants |
| Major Depressive Disorder (MDD) | 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. | Inbound, Week 8 | 0 participants |
| Major Depressive Disorder (MDD) | 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. | Inbound, Week 7 | 3 participants |
| Major Depressive Disorder (MDD) | 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. | Inbound, Week 1 | 8 participants |
| Major Depressive Disorder (MDD) | 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. | Inbound, Week >8 | 0 participants |
| Major Depressive Disorder (MDD) | 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. | Outbound, Baseline | 0 participants |
| Major Depressive Disorder (MDD) | 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. | Outbound, Week 1 | 12 participants |
| Major Depressive Disorder (MDD) | 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. | Inbound, Week 2 | 4 participants |
| Schizophrenia (SCH) | 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. | Outbound, Week >8 | 0 participants |
| Schizophrenia (SCH) | 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. | Inbound, Week 5 | 4 participants |
| Schizophrenia (SCH) | 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. | Inbound, Baseline | 1 participants |
| Schizophrenia (SCH) | 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. | Inbound, Week 1 | 9 participants |
| Schizophrenia (SCH) | 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. | Inbound, Week 2 | 6 participants |
| Schizophrenia (SCH) | 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. | Inbound, Week 3 | 3 participants |
| Schizophrenia (SCH) | 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. | Inbound, Week 4 | 5 participants |
| Schizophrenia (SCH) | 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. | Inbound, Week 6 | 6 participants |
| Schizophrenia (SCH) | 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. | Inbound, Week 7 | 3 participants |
| Schizophrenia (SCH) | 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. | Inbound, Week 8 | 4 participants |
| Schizophrenia (SCH) | 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. | Inbound, Week >8 | 1 participants |
| Schizophrenia (SCH) | 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. | Outbound, Baseline | 0 participants |
| Schizophrenia (SCH) | 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. | Outbound, Week 1 | 15 participants |
| Schizophrenia (SCH) | 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. | Outbound, Week 2 | 15 participants |
| Schizophrenia (SCH) | 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. | Outbound, Week 3 | 3 participants |
| Schizophrenia (SCH) | 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. | Outbound, Week 4 | 4 participants |
| Schizophrenia (SCH) | 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. | Outbound, Week 5 | 2 participants |
| Schizophrenia (SCH) | 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. | Outbound, Week 6 | 5 participants |
| Schizophrenia (SCH) | 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. | Outbound, Week 7 | 4 participants |
| Schizophrenia (SCH) | 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. | Outbound, Week 8 | 5 participants |