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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

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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.

Tracking Information
First Submitted Date  ICMJE August 21, 2018
First Posted Date  ICMJE August 22, 2018
Results First Submitted Date  ICMJE October 17, 2019
Results First Posted Date  ICMJE November 8, 2019
Last Update Posted Date November 8, 2019
Actual Study Start Date  ICMJE June 28, 2018
Actual Primary Completion Date October 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2019)
Difference In The Number Of Participants With All-cause Hospitalizations For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180 [ Time Frame: Baseline through Day 180 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
All-cause hospitalizations [ Time Frame: up to 180 Days ]
Difference in proportion of patients with all-cause hospitalizations for patients using Abilify MyCite versus Virtual Matched Controls.
Change History Complete list of historical versions of study NCT03643159 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2019)
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 [ Time Frame: Baseline through Day 180 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
Proportion of Days Covered [ Time Frame: Up to 180 Days ]
Difference between groups (Abilify MyCite versus Virtual Matched Controls) in proportion of patients with at least 80% proportion of days covered (PDC) with antipsychotic medication.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Multicenter, 180-day Pragmatic Clinical Trial to Measure the Difference in All-cause Hospitalizations for Patients Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder
Brief Summary The primary objective of this pragmatic clinical trial (Main Study) was to assess the difference between all-cause hospitalizations in participants using Abilify MyCite versus virtual matched controls. In addition, secondary and exploratory objectives were to assess medication adherence, healthcare utilization and costs, and patient-reported outcomes.
Detailed Description

This was a phase 4, open-label, prospective, pragmatic clinical trial to assess the difference between all-cause hospitalizations in participants using Abilify MyCite (for Months 1-3, then prohibited for Months 4-6) versus virtual matched controls from baseline to Day 180. Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which was oral aripiprazole or any other product). Eligible participants entered a screening period of up to 13 days. For participants enrolling into the study, those not on aripiprazole at screening used the screening period for conversion to aripiprazole from other antipsychotics. 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.

After the visit at Day 180, a second, optional interventional period (up to 6 months of Abilify MyCite) could have been initiated per the joint decision of the participants with their study physician; participants in this second, optional interventional period were to have a visit at Day 360. During this second, optional interventional period, participants may have started and stopped Abilify MyCite as clinically indicated.

A parallel exploratory study that would utilize a different set of physicians and participants from the main study was planned; however, that study was never initiated.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Schizophrenia
  • Bipolar 1 Disorder
  • Major Depressive Disorder
Intervention  ICMJE
  • Combination Product: Abilify MyCite - Digital Medicine System
    The Abilify MyCite system is a drug-device combination product comprised of aripiprazole (an atypical antipsychotic) tablets embedded with a sensor that communicates with a patch (wearable sensor) and a medical software application with collected information (ingestion, mood, activity, rest) tracked and summarized for participants, healthcare providers, and potential caregivers. Abilify MyCite is intended to track drug ingestion and is indicated for the treatment of adults with schizophrenia (SCH), bipolar 1 disorder (BP1) (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with major depressive disorder (MDD).
  • Drug: Aripiprazole or other oral antipsychotics
    For the treatment of adults with SCH, BP1 (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with MDD.
Study Arms  ICMJE
  • Experimental: Abilify MyCite
    Participants received Abilify MyCite during Months 1-3. During Months 4-6 use of Abilify MyCite was to be prohibited. Thereafter, at Day 180, a second, optional interventional period (up to 6 months of Abilify MyCite) could have been initiated per the joint decision of the participants with their study physician.
    Interventions:
    • Combination Product: Abilify MyCite - Digital Medicine System
    • Drug: Aripiprazole or other oral antipsychotics
  • Active Comparator: Virtual Matched Controls
    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.
    Intervention: Drug: Aripiprazole or other oral antipsychotics
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 14, 2018)
2
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2018)
790
Actual Study Completion Date  ICMJE October 17, 2018
Actual Primary Completion Date October 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants are actively enrolled in an Anthem-affiliated commercial, Medicaid, or Medicare health plan with medical and pharmacy benefits.
  • Participants must have a smartphone with data plan.
  • Participants currently prescribed aripiprazole, or appropriate for aripiprazole treatment.
  • Participants must have a current diagnosis of SCH, BP1, or MDD.

Exclusion Criteria:

  • Any participant who participated in another clinical trial within 30 days of enrollment into the current study.
  • Females who are breast-feeding and/or who are pregnant at the time of study enrollment, or who plan to become pregnant during the study.
  • Participants who are currently being treated with a long-acting injectable antipsychotic.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 63 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03643159
Other Study ID Numbers  ICMJE 316-13-217
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP