Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03643159
Recruitment Status : Terminated (Difficulty in participant recruitment)
First Posted : August 22, 2018
Results First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions Schizophrenia
Bipolar 1 Disorder
Major Depressive Disorder
Interventions Combination Product: Abilify MyCite - Digital Medicine System
Drug: Aripiprazole or other oral antipsychotics
Enrollment 2
Recruitment Details  
Pre-assignment Details Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis. Since the study was terminated early, no matching occurred.
Arm/Group Title Abilify MyCite
Hide Arm/Group Description Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol.
Period Title: Overall Study
Started 2
Received At Least 1 Dose Of Study Drug 2
Completed 0
Not Completed 2
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Arm/Group Title Abilify MyCite Virtual Matched Controls Total
Hide Arm/Group Description Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol. Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which could have been oral aripiprazole or any other product) throughout the duration of the trial. Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis. Total of all reporting groups
Overall Number of Baseline Participants 2 0 2
Hide Baseline Analysis Population Description
Safety: All participants who received at least 1 dose of Abilify MyCite or who were a virtual matched control.
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
<=18 years 0 0 0
Between 18 and 65 years 0 0 0
>=65 years 0 0 0
[1]
Measure Analysis Population Description: Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
Female 0 0 0
Male 0 0 0
[1]
Measure Analysis Population Description: Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
Hispanic or Latino 0 0 0
Not Hispanic or Latino 0 0 0
Unknown or Not Reported 0 0 0
[1]
Measure Analysis Population Description: Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
American Indian or Alaska Native 0 0 0
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 0 0 0
White 0 0 0
More than one race 0 0 0
Unknown or Not Reported 0 0 0
[1]
Measure Analysis Population Description: Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
1.Primary Outcome
Title Difference In The Number Of Participants With All-cause Hospitalizations For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180
Hide Description This outcome measure describes the difference in all-cause hospitalizations (that is hospitalizations for any reason) between the number of participants using Abilify MyCite and those receiving treatment as usual (the virtual matched controls). Due to early study termination, efficacy data were not collected.
Time Frame Baseline through Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis: All participants who received at least 1 dose of Abilify MyCite or who were a virtual matched control and had efficacy data. Both participants were excluded from efficacy analysis because they discontinued study therapy early. In addition, efficacy data were not collected due to early study termination.
Arm/Group Title Abilify MyCite Virtual Matched Controls
Hide Arm/Group Description:
Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol.
Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which could have been oral aripiprazole or any other product) throughout the duration of the trial. Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Difference In The Number Of Participants With At Least 80% Proportion Of Days Covered (PDC) (With Antipsychotic Medication) For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180
Hide Description This outcome measure describes the difference in the number of participants with at least 80% PDC (with antipsychotic medication) between those using Abilify MyCite and those receiving treatment as usual (the virtual matched controls). Due to early study termination, efficacy data were not collected.
Time Frame Baseline through Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis: All participants who received at least 1 dose of Abilify MyCite or who were a virtual matched control and had efficacy data. Both participants were excluded from efficacy analysis because they discontinued study therapy early. In addition, efficacy data were not collected due to early study termination.
Arm/Group Title Abilify MyCite Virtual Matched Controls
Hide Arm/Group Description:
Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol.
Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which could have been oral aripiprazole or any other product) throughout the duration of the trial. Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline (Day 0) to Day 49
Adverse Event Reporting Description The 2 enrolled participants both received Abilify MyCite. According to protocol, serious and other adverse events were not to be assessed for Virtual Matched Controls.
 
Arm/Group Title Abilify MyCite
Hide Arm/Group Description Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol.
All-Cause Mortality
Abilify MyCite
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Abilify MyCite
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Abilify MyCite
Affected / at Risk (%)
Total   1/2 (50.00%) 
Skin and subcutaneous tissue disorders   
Rash  1  1/2 (50.00%) 
1
Term from vocabulary, MedDra 22.0
Indicates events were collected by systematic assessment
This study was terminated by the Sponsor due to difficulty in participant recruitment, leading to a small number of participants enrolled. Due to early termination of the study, no efficacy data were collected.
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.
Sponsor reserves the right to review, edit, and authorize publications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Development
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: +1-609-524-6788
EMail: clinicaltransparency@otsuka-us.com
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03643159     History of Changes
Other Study ID Numbers: 316-13-217
First Submitted: August 21, 2018
First Posted: August 22, 2018
Results First Submitted: October 17, 2019
Results First Posted: November 8, 2019
Last Update Posted: November 8, 2019