A Trial in Adult Participants With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®

A Phase IIIb Multi-Center, Open-Label, Mirror-Image, Trial in Adult Subjects With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®

To compare inpatient psychiatric hospitalization rates while participants are on oral standard-of-care antipsychotic treatment and later switched to Abilify MyCite®.

Study Overview

• Status: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Combination product: Abilify MyCite®

Detailed Description

This study is designed to assess the difference between inpatient psychiatric hospitalization rates in participants on oral standard-of-care antipsychotic treatment(s) for a period of 6 months followed by a switch to Abilify MyCite® for a period of 3 months (Months 1 to 3).

At the Month 3 visit, the investigator should decide if participants will continue on Abilify MyCite® for an additional 3 months (Months 4 to 6) or switch to a standard-of-care treatment for the duration of treatment.

Participants must have had at least 1 inpatient psychiatric hospitalization within 4 years (48 months) and must have been prescribed oral antipsychotics for at least 6 months or longer prior to screening.

Participants will enter a screening period (up to 45 days). If deemed eligible to participate, participants will enter an open-label Abilify MyCite® treatment prospective phase for up to 6 months.

All participants who complete or withdraw from the trial while on Abilify MyCite® will receive a telephone call for safety follow-up approximately 30 days after their last trial visit.

The trial will be conducted at 75 sites in the United States, 493 participants will be screened in order to enroll 320 participants and complete 224 participants. There was an interim analysis planned for the study.

• Study Type: Interventional
• Enrollment (Actual): 277
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Alea Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center, Inc.
    • Bellflower, California, United States, 90706
      • CiTrials
    • Cerritos, California, United States, 90703
      • Synexus
    • Colton, California, United States, 92324
      • CMB Clinical Trials
    • Culver City, California, United States, 90230
      • Proscience Research Group
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Network, LLC
    • Glendale, California, United States, 91206
      • Behavioral Research Specialists, LLC
    • Granada Hills, California, United States, 91344
      • San Fernando Mental Health Center
    • Lancaster, California, United States, 93534
      • Om Research LLC
    • Lemon Grove, California, United States, 91945
      • Synergy San Diego
    • Los Angeles, California, United States, 90024
      • CalNeuro Research Group
    • Oakland, California, United States, 94607
      • Pacific Research Partners
    • Oceanside, California, United States, 92056
      • Excell Research, Inc
    • Pico Rivera, California, United States, 90660
      • CNRI-Los Angeles
    • Rancho Cucamonga, California, United States, 91730
      • Prospective Research Innovations Inc.
    • Riverside, California, United States, 92506
      • CiTrials
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • San Diego, California, United States, 92102
      • CNRI-San Diego, LLC
    • Santa Ana, California, United States, 92705
      • CITrials, Inc.
    • Santa Rosa, California, United States, 95401
      • Siyan Clinical Research
    • Torrance, California, United States, 90502
      • Collaborative Neuroscience Network, LLC
  • Florida
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Hialeah, Florida, United States, 33016
      • Galiz Research
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc.
    • Hialeah, Florida, United States, 33012
      • New Life medical Research Inc.
    • Lauderhill, Florida, United States, 33319
      • Innovative Clinical Research, Inc.
    • Miami, Florida, United States, 33133
      • CCM Clinical Research Group
    • Miami, Florida, United States, 33122
      • Premier Clinical Research Institute Inc.
    • Miami, Florida, United States, 33133
      • Prestige Clinical Research Center Inc.
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Tirlas
    • Winter Park, Florida, United States, 32789
      • Nova Psychiatry, INC
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Synexus Clinical Research US
    • Atlanta, Georgia, United States, 30303
      • Emory
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta
    • Savannah, Georgia, United States, 31405
      • iResearch Savannah
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Uptown Research Institute
    • Hoffman Estates, Illinois, United States, 60169
      • AMITA Health
    • Springfield, Illinois, United States, 62702
      • SIU School of Medicine
  • Louisiana
    • Lake Charles, Louisiana, United States, 70629
      • Lake Charles Clinical Trial
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • Michigan Clinical Research Institute
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • PsychCare Consultants Research
    • Saint Louis, Missouri, United States, 63118
      • Arch Clinical Trials, LLC
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Alivation Research, LLC.
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Altea Research Institute
    • Las Vegas, Nevada, United States, 89109
      • Kolade Research Institute/Cal Psychiatric Services
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
  • New York
    • Jamaica, New York, United States, 11432
      • Synexus US
    • New York, New York, United States, 10036
      • Manhattan Behavioral Medicine PLLC
    • New York, New York, United States, 10035
      • Manhattan Psychiatric Center
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research
    • Staten Island, New York, United States, 10312
      • Richmond Behavioral Associates
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
    • Fairlawn, Ohio, United States, 44333
      • Signature Research Associates Inc
    • Garfield Heights, Ohio, United States, 44125
      • Charak Clinical Research Center
    • North Canton, Ohio, United States, 44720
      • Neuro-Behavioral Clinical Research, Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Cutting Edge Research Group
    • Oklahoma City, Oklahoma, United States, 73112
      • The Rivus Wellness & Research Institute
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Psychiatric Consultants, PC
  • Texas
    • Austin, Texas, United States, 78754
      • Community Clinical Research, Inc.
    • DeSoto, Texas, United States, 75115
      • InSite Clinical Research
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Richardson, Texas, United States, 75080
      • Pillar Clinical Research
  • Utah
    • Springville, Utah, United States, 84663
      • Noetic Psychiatry
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants must be willing and able to give written informed consent, adhere to trial procedures and able to read and understand English.
• Male and female participants 18 to 65 years of age.
• Participants must possess a smartphone and is familiar with its use and is willing to download and interact with the Abilify MyCite® app. Participants with a smartphone, that is not compatible with the Abilify MyCite® app will be offered a loaner phone for the trial period.
• Clinical diagnosis of schizophrenia and able to ingest oral medication.
• Positive and Negative Syndrome Scale (PANSS) total score between 60-90.
• Participants currently prescribed oral atypical antipsychotic medication including aripiprazole or appropriate for aripiprazole treatment for 6 months or longer.
• Participants are required to have had an inpatient hospitalization for schizophrenia within the last 48 months prior to entering the trial.
• Skin on the anterior chest just above the lower edge of the rib cage that is free of any dermatological problems.

Exclusion Criteria:

• Females who are breast-feeding and/or who are pregnant.
• Sexually active males or women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of Abilify MyCite®.
• Any participants who participated in another clinical trial within 30 days of enrollment.
• Participants who are currently being treated with an LAI antipsychotic or have been treated with an LAI in the retrospective 6-month phase.
• Participants with a current DSM-5 diagnosis other than schizophrenia.
• Participants with a known allergy to adhesive tape or any pertinent components of the patch or aripiprazole tablet embedded with an IEM sensor.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abilify MyCite®; Participants received Abilify MyCite® a combination product of aripiprazole tablet embedded with sensor and wearable patch for 3 months (Months 1 to 3) and continued for an additional 3 months (Months 4 to 6) as per investigators assessment or switch to a standard-of-care treatment of oral atypical antipsychotics or a long acting injectable.	Combination product: Abilify MyCite®; Combination product of aripiprazole tablet embedded with sensor and wearable patch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Inpatient Psychiatric Hospitalization	Percentage of participants with inpatient psychiatric hospitalization in Prospective Period With at least one hospitalization in Retrospective Period.	Retrospective Period [Month -6 to Baseline (Day 1)] up to Prospective Period (Day 1 to Month 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Days With Improved Adherence	Improved adherence was based on the overall proportion of days covered (PDC) in participants compliant with study drug administration in the Prospective period on Prospective Abilify MyCite® versus Retrospective Period on oral atypical antipsychotics. PDC was calculated as = number of days 'covered' in the Respective Period/number of days in the period * 100.	Retrospective Period [-1 to -3 months prior to Baseline (Day 1)] up to Prospective Period (1 to 3 months)

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications and helpful links

General Publications

• Cohen EA, Skubiak T, Hadzi Boskovic D, Norman K, Knights J, Fang H, Coppin-Renz A, Peters-Strickland T, Lindenmayer JP, Reuteman-Fowler JC. Phase 3b Multicenter, Prospective, Open-label Trial to Evaluate the Effects of a Digital Medicine System on Inpatient Psychiatric Hospitalization Rates for Adults With Schizophrenia. J Clin Psychiatry. 2022 Apr 11;83(3):21m14132. doi: 10.4088/JCP.21m14132.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2019
• Primary Completion (Actual): August 12, 2020
• Study Completion (Actual): September 29, 2020

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; 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
• Other Study ID Numbers: 031-201-00301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

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