Trial Outcomes & Findings for Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System (NCT NCT02722967)
NCT ID: NCT02722967
Last Updated: 2018-05-23
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
From baseline upto week 9
Results posted on
2018-05-23
Participant Flow
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.
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).
Participant milestones
| Measure |
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.
|
Major Depressive Disorder (MDD)
This group consisted of the participants with adjunctive treatment of MDD who were being treated with oral aripiprazole.
|
Schizophrenia (SCH)
This group consisted of the participants with SCH who were being treated with oral aripiprazole.
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
12
|
15
|
|
Overall Study
COMPLETED
|
17
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
4
|
Reasons for withdrawal
| Measure |
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.
|
Major Depressive Disorder (MDD)
This group consisted of the participants with adjunctive treatment of MDD who were being treated with oral aripiprazole.
|
Schizophrenia (SCH)
This group consisted of the participants with SCH who were being treated with oral aripiprazole.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Non-compliance with patch wearing
|
2
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Non-adherence of the patch to the skin
|
0
|
0
|
2
|
Baseline Characteristics
Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
Baseline characteristics by cohort
| Measure |
Bipolar 1 Disorder (BP1)
n=22 Participants
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.
|
Major Depressive Disorder (MDD)
n=12 Participants
This group consisted of the participants with adjunctive treatment of major depressive disorder who were treated with oral aripiprazole.
|
Schizophrenia (SCH)
n=15 Participants
This group consisted of the participants with schizophrenia who were treated with oral aripiprazole.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
45.5 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline upto week 9Population: Intent-to-treat (ITT) Sample: All subjects who entered the trial and used Digital Medicine System (DMS).
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
Outcome measures
| Measure |
Bipolar 1 Disorder (BP1)
n=22 Participants
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
|
Major Depressive Disorder (MDD)
n=12 Participants
This group consisted of the participants with adjunctive treatment of major depressive disorder who were treated with oral aripiprazole.
|
Schizophrenia (SCH)
n=15 Participants
This group consisted of the participants with schizophrenia who were treated with oral aripiprazole.
|
|---|---|---|---|
|
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
|
0 participants
|
1 participants
|
|
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
|
8 participants
|
9 participants
|
|
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
|
4 participants
|
6 participants
|
|
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
|
1 participants
|
3 participants
|
|
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
|
2 participants
|
5 participants
|
|
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
|
2 participants
|
4 participants
|
|
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
|
3 participants
|
6 participants
|
|
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
|
3 participants
|
3 participants
|
|
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
|
0 participants
|
4 participants
|
|
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
|
0 participants
|
1 participants
|
|
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
|
0 participants
|
0 participants
|
|
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
|
12 participants
|
15 participants
|
|
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
|
12 participants
|
15 participants
|
|
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
|
4 participants
|
3 participants
|
|
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
|
3 participants
|
4 participants
|
|
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
|
3 participants
|
2 participants
|
|
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
|
2 participants
|
5 participants
|
|
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
|
4 participants
|
4 participants
|
|
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
|
5 participants
|
5 participants
|
|
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
|
2 participants
|
0 participants
|
Adverse Events
Bipolar 1 Disorder (BP1)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Major Depressive Disorder (MDD)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Schizophrenia (SCH)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bipolar 1 Disorder (BP1)
n=22 participants at risk
This group consisted of the participants with acute treatment of manic and mixed episodes associated with BP1 who were being treated with oral aripiprazole.
|
Major Depressive Disorder (MDD)
n=12 participants at risk
This group consisted of the participants with adjunctive treatment of MDD who were being treated with oral aripiprazole.
|
Schizophrenia (SCH)
n=15 participants at risk
This group consisted of the participants with SCH who were being treated with oral aripiprazole.
|
|---|---|---|---|
|
General disorders
Peripheral Swelling
|
0.00%
0/22 • 9 Weeks
|
0.00%
0/12 • 9 Weeks
|
6.7%
1/15 • Number of events 1 • 9 Weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/22 • 9 Weeks
|
8.3%
1/12 • Number of events 1 • 9 Weeks
|
0.00%
0/15 • 9 Weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.5%
1/22 • Number of events 1 • 9 Weeks
|
8.3%
1/12 • Number of events 1 • 9 Weeks
|
0.00%
0/15 • 9 Weeks
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.00%
0/22 • 9 Weeks
|
8.3%
1/12 • Number of events 1 • 9 Weeks
|
0.00%
0/15 • 9 Weeks
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/22 • 9 Weeks
|
8.3%
1/12 • Number of events 1 • 9 Weeks
|
0.00%
0/15 • 9 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/22 • 9 Weeks
|
0.00%
0/12 • 9 Weeks
|
6.7%
1/15 • Number of events 2 • 9 Weeks
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Number of events 1 • 9 Weeks
|
8.3%
1/12 • Number of events 1 • 9 Weeks
|
0.00%
0/15 • 9 Weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/22 • 9 Weeks
|
8.3%
1/12 • Number of events 1 • 9 Weeks
|
0.00%
0/15 • 9 Weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.1%
2/22 • Number of events 2 • 9 Weeks
|
0.00%
0/12 • 9 Weeks
|
0.00%
0/15 • 9 Weeks
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.5%
1/22 • Number of events 3 • 9 Weeks
|
8.3%
1/12 • Number of events 1 • 9 Weeks
|
0.00%
0/15 • 9 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.7%
5/22 • Number of events 5 • 9 Weeks
|
50.0%
6/12 • Number of events 6 • 9 Weeks
|
0.00%
0/15 • 9 Weeks
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/22 • 9 Weeks
|
8.3%
1/12 • Number of events 1 • 9 Weeks
|
0.00%
0/15 • 9 Weeks
|
Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER