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Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System

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ClinicalTrials.gov Identifier: NCT02722967
Recruitment Status : Completed
First Posted : March 30, 2016
Results First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Schizophrenia
Major Depressive Disorder
Bipolar I Disorder
Intervention Drug: Aripiprazole + IEM (Ingestible Event Marker)
Enrollment 49
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).
Arm/Group Title Bipolar 1 Disorder (BP1) Major Depressive Disorder (MDD) Schizophrenia (SCH)
Hide 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
Reason Not Completed
Adverse Event             1             0             0
Lost to Follow-up             0             1             0
Non-compliance with patch wearing             2             1             1
Withdrawal by Subject             1             0             1
Physician Decision             1             0             0
Non-adherence of the patch to the skin             0             0             2
Arm/Group Title Bipolar 1 Disorder (BP1) Major Depressive Disorder (MDD) Schizophrenia (SCH) Total
Hide 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 Number of Baseline Participants 22 12 15 49
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) Sample: All subjects who entered the trial and used Digital Medicine System (DMS).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 12 participants 15 participants 49 participants
45.5  (15.2) 49.3  (11.2) 45.5  (11.1) 46.4  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 12 participants 15 participants 49 participants
Female
15
  68.2%
7
  58.3%
9
  60.0%
31
  63.3%
Male
7
  31.8%
5
  41.7%
6
  40.0%
18
  36.7%
1.Primary Outcome
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.
Hide 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:

  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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 22 12 15
Measure Type: Number
Unit of Measure: participants
Inbound, Baseline 0 0 1
Inbound, Week 1 8 8 9
Inbound, Week 2 7 4 6
Inbound, Week 3 2 1 3
Inbound, Week 4 4 2 5
Inbound, Week 5 4 2 4
Inbound, Week 6 0 3 6
Inbound, Week 7 1 3 3
Inbound, Week 8 2 0 4
Inbound, Week >8 0 0 1
Outbound, Baseline 0 0 0
Outbound, Week 1 22 12 15
Outbound, Week 2 22 12 15
Outbound, Week 3 6 4 3
Outbound, Week 4 6 3 4
Outbound, Week 5 5 3 2
Outbound, Week 6 7 2 5
Outbound, Week 7 9 4 4
Outbound, Week 8 7 5 5
Outbound, Week >8 4 2 0
Time Frame 9 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bipolar 1 Disorder (BP1) Major Depressive Disorder (MDD) Schizophrenia (SCH)
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      0/12 (0.00%)      0/15 (0.00%)    
Show Serious Adverse Events Hide 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 (0.00%)      0/12 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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 (45.45%)      9/12 (75.00%)      1/15 (6.67%)    
General disorders       
Peripheral Swelling * 1  0/22 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1
Infections and infestations       
Sinusitis * 1  0/22 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0
Upper Respiratory Tract Infection * 1  1/22 (4.55%)  1 1/12 (8.33%)  1 0/15 (0.00%)  0
Injury, poisoning and procedural complications       
Meniscus Injury * 1  0/22 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0
Sunburn * 1  0/22 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Pain In Extremity * 1  0/22 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  2
Nervous system disorders       
Headache * 1  1/22 (4.55%)  1 1/12 (8.33%)  1 0/15 (0.00%)  0
Syncope * 1  0/22 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0
Skin and subcutaneous tissue disorders       
Erythema * 1  2/22 (9.09%)  2 0/12 (0.00%)  0 0/15 (0.00%)  0
Pruritis * 1  1/22 (4.55%)  3 1/12 (8.33%)  1 0/15 (0.00%)  0
Rash * 1  5/22 (22.73%)  5 6/12 (50.00%)  6 0/15 (0.00%)  0
Skin Irritation * 1  0/22 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Global Clinical Development
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.
EMail: DT-inquiry@otsuka.jp
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02722967     History of Changes
Other Study ID Numbers: 316-13-215
First Submitted: March 13, 2016
First Posted: March 30, 2016
Results First Submitted: March 15, 2018
Results First Posted: May 23, 2018
Last Update Posted: May 23, 2018