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

Otsuka

Status and phase: Terminated; Phase 4

Conditions: Major Depressive Disorder; Schizophrenia; Bipolar 1 Disorder

Treatments: Drug: Aripiprazole or other oral antipsychotics; Combination Product: Abilify MyCite - Digital Medicine System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03643159

316-13-217

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 63 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Abilify MyCite

Experimental group

Description:

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.

Treatment:

Combination Product: Abilify MyCite - Digital Medicine System

Drug: Aripiprazole or other oral antipsychotics

Virtual Matched Controls

Active Comparator group

Description:

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.

Treatment:

Drug: Aripiprazole or other oral antipsychotics