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

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

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.

Study Overview

• Status: Terminated
• Conditions: Schizophrenia; Major Depressive Disorder; Bipolar 1 Disorder
• Intervention / Treatment: Combination product: Abilify MyCite - Digital Medicine System; Drug: Aripiprazole or other oral antipsychotics

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: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Rosa, California, United States, 95401
      • Siyan Clinical Research
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Psychiatric Addiction Curative/PACT Atlanta LLC
    • Smyrna, Georgia, United States, 30080
      • Georgia Psychiatry and Sleep
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Kolade Research Institute
  • Ohio
    • Fairlawn, Ohio, United States, 44333
      • Signature Research Associates, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 63 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference In The Number Of Participants With All-cause Hospitalizations For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To 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.	Baseline through Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline through Day 180

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 28, 2018
• Primary Completion (ACTUAL): October 17, 2018
• Study Completion (ACTUAL): October 17, 2018

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (ACTUAL): August 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Digital Medicine System
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Depression; Depressive Disorder; Schizophrenia; Disease; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole; Antipsychotic Agents
• Other Study ID Numbers: 316-13-217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No