Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Aripiprazole + IEM 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. |
Drug: Aripiprazole + 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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: Inbound calls (ie, calls from the subject to the integrated call center) by help type; 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Granada Hills | California | United States | 91344 | |
| 2 | Rochester | New York | United States | 14603 | |
| 3 | Durham | North Carolina | United States | 27714 | |
| 4 | Richmond | Virginia | United States | 23230 |
Sponsors and Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
- Study Director: Tim Peters-Strickland, M.D., Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 316-13-215
Study Results
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 Detail | 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). |
| Arm/Group Title | Bipolar 1 Disorder (BP1) | Major Depressive Disorder (MDD) | Schizophrenia (SCH) |
|---|---|---|---|
| Arm/Group Description | This group consisted of the participants with acute treatment of manic and mixed episodes associated with BP1 who were being treated with oral aripiprazole. | This group consisted of the participants with adjunctive treatment of MDD who were being treated with oral aripiprazole. | This group consisted of the participants with SCH who were being treated with oral aripiprazole. |
| Period Title: Overall Study | |||
| STARTED | 22 | 12 | 15 |
| COMPLETED | 17 | 10 | 11 |
| NOT COMPLETED | 5 | 2 | 4 |
Baseline Characteristics
| Arm/Group Title | Bipolar 1 Disorder (BP1) | Major Depressive Disorder (MDD) | Schizophrenia (SCH) | Total |
|---|---|---|---|---|
| Arm/Group Description | 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. | This group consisted of the participants with adjunctive treatment of major depressive disorder who were treated with oral aripiprazole. | This group consisted of the participants with schizophrenia who were treated with oral aripiprazole. | Total of all reporting groups |
| Overall Participants | 22 | 12 | 15 | 49 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
45.5
(15.2)
|
49.3
(11.2)
|
45.5
(11.1)
|
46.4
(13.0)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
15
68.2%
|
7
58.3%
|
9
60%
|
31
63.3%
|
| Male |
7
31.8%
|
5
41.7%
|
6
40%
|
18
36.7%
|
Outcome Measures
| Title | 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. |
|---|---|
| Description | 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: Inbound calls (ie, calls from the subject to the integrated call center) by help type; 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) Sample: All subjects who entered the trial and used Digital Medicine System (DMS). |
| Arm/Group Title | Bipolar 1 Disorder (BP1) | Major Depressive Disorder (MDD) | Schizophrenia (SCH) |
|---|---|---|---|
| Arm/Group Description | 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 | This group consisted of the participants with adjunctive treatment of major depressive disorder who were treated with oral aripiprazole. | This group consisted of the participants with schizophrenia who were treated with oral aripiprazole. |
| Measure Participants | 22 | 12 | 15 |
| Inbound, Baseline |
0
0%
|
0
0%
|
1
6.7%
|
| Inbound, Week 1 |
8
36.4%
|
8
66.7%
|
9
60%
|
| Inbound, Week 2 |
7
31.8%
|
4
33.3%
|
6
40%
|
| Inbound, Week 3 |
2
9.1%
|
1
8.3%
|
3
20%
|
| Inbound, Week 4 |
4
18.2%
|
2
16.7%
|
5
33.3%
|
| Inbound, Week 5 |
4
18.2%
|
2
16.7%
|
4
26.7%
|
| Inbound, Week 6 |
0
0%
|
3
25%
|
6
40%
|
| Inbound, Week 7 |
1
4.5%
|
3
25%
|
3
20%
|
| Inbound, Week 8 |
2
9.1%
|
0
0%
|
4
26.7%
|
| Inbound, Week >8 |
0
0%
|
0
0%
|
1
6.7%
|
| Outbound, Baseline |
0
0%
|
0
0%
|
0
0%
|
| Outbound, Week 1 |
22
100%
|
12
100%
|
15
100%
|
| Outbound, Week 2 |
22
100%
|
12
100%
|
15
100%
|
| Outbound, Week 3 |
6
27.3%
|
4
33.3%
|
3
20%
|
| Outbound, Week 4 |
6
27.3%
|
3
25%
|
4
26.7%
|
| Outbound, Week 5 |
5
22.7%
|
3
25%
|
2
13.3%
|
| Outbound, Week 6 |
7
31.8%
|
2
16.7%
|
5
33.3%
|
| Outbound, Week 7 |
9
40.9%
|
4
33.3%
|
4
26.7%
|
| Outbound, Week 8 |
7
31.8%
|
5
41.7%
|
5
33.3%
|
| Outbound, Week >8 |
4
18.2%
|
2
16.7%
|
0
0%
|
Adverse Events
| Time Frame | 9 Weeks | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Bipolar 1 Disorder (BP1) | Major Depressive Disorder (MDD) | Schizophrenia (SCH) | |||
| Arm/Group Description | This group consisted of the participants with acute treatment of manic and mixed episodes associated with BP1 who were being treated with oral aripiprazole. | This group consisted of the participants with adjunctive treatment of MDD who were being treated with oral aripiprazole. | This group consisted of the participants with SCH who were being treated with oral aripiprazole. | |||
All Cause Mortality |
||||||
| Bipolar 1 Disorder (BP1) | Major Depressive Disorder (MDD) | Schizophrenia (SCH) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/22 (0%) | 0/12 (0%) | 0/15 (0%) | |||
Serious Adverse Events |
||||||
| Bipolar 1 Disorder (BP1) | Major Depressive Disorder (MDD) | Schizophrenia (SCH) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/22 (0%) | 0/12 (0%) | 0/15 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Bipolar 1 Disorder (BP1) | Major Depressive Disorder (MDD) | Schizophrenia (SCH) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/22 (45.5%) | 9/12 (75%) | 1/15 (6.7%) | |||
| General disorders | ||||||
| Peripheral Swelling | 0/22 (0%) | 0 | 0/12 (0%) | 0 | 1/15 (6.7%) | 1 |
| Infections and infestations | ||||||
| Sinusitis | 0/22 (0%) | 0 | 1/12 (8.3%) | 1 | 0/15 (0%) | 0 |
| Upper Respiratory Tract Infection | 1/22 (4.5%) | 1 | 1/12 (8.3%) | 1 | 0/15 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Meniscus Injury | 0/22 (0%) | 0 | 1/12 (8.3%) | 1 | 0/15 (0%) | 0 |
| Sunburn | 0/22 (0%) | 0 | 1/12 (8.3%) | 1 | 0/15 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Pain In Extremity | 0/22 (0%) | 0 | 0/12 (0%) | 0 | 1/15 (6.7%) | 2 |
| Nervous system disorders | ||||||
| Headache | 1/22 (4.5%) | 1 | 1/12 (8.3%) | 1 | 0/15 (0%) | 0 |
| Syncope | 0/22 (0%) | 0 | 1/12 (8.3%) | 1 | 0/15 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Erythema | 2/22 (9.1%) | 2 | 0/12 (0%) | 0 | 0/15 (0%) | 0 |
| Pruritis | 1/22 (4.5%) | 3 | 1/12 (8.3%) | 1 | 0/15 (0%) | 0 |
| Rash | 5/22 (22.7%) | 5 | 6/12 (50%) | 6 | 0/15 (0%) | 0 |
| Skin Irritation | 0/22 (0%) | 0 | 1/12 (8.3%) | 1 | 0/15 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Global Clinical Development |
|---|---|
| Organization | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Phone | |
| DT-inquiry@otsuka.jp |
- 316-13-215