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

NCT03643159 | Terminated Phase 4 Results FDA Drug FDA Device

• 1 other identifier: 316-13-217
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 5

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.

Conditions

Schizophrenia; Bipolar 1 Disorder; Major Depressive Disorder

Keywords

Digital Medicine System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  Baseline through Day 180

Study Arms (2)

Abilify MyCite

EXPERIMENTAL

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; Drug: Aripiprazole or other oral antipsychotics

Virtual Matched Controls

ACTIVE COMPARATOR

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

Interventions

Abilify MyCite - Digital Medicine System COMBINATION_PRODUCT

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).

Abilify MyCite

Aripiprazole or other oral antipsychotics DRUG

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.

Abilify MyCite; Virtual Matched Controls

Eligibility Criteria

• Age: 18 Years - 63 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (5)

Siyan Clinical Research

Santa Rosa, California, 95401, United States

Location

Psychiatric Addiction Curative/PACT Atlanta LLC

Decatur, Georgia, 30030, United States

Location

Georgia Psychiatry and Sleep

Smyrna, Georgia, 30080, United States

Location

Kolade Research Institute

Las Vegas, Nevada, 89109, United States

Location

Signature Research Associates, Inc.

Fairlawn, Ohio, 44333, United States

Location

MeSH Terms

Conditions

Schizophrenia; Depressive Disorder, Major

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

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.

Results Point of Contact

• Title: Global Clinical Development
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

clinicaltransparency@otsuka-us.com

+1-609-524-6788

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 22, 2018
• Study Start: June 28, 2018
• Primary Completion: October 17, 2018
• Study Completion: October 17, 2018
• Last Updated: November 8, 2019
• Results First Posted: November 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)