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SchizophreniaPhase 3NCT03892889

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

A Phase 3 study testing Abilify MyCite® in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 68 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Abilify MyCite®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
277 participants
Where
68 sitesUnited States
Study dates
29 Apr 2019to 29 Sep 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

68 sites in 1 country.

68 sites in 1 country

United States68 sites

  • ADVANCED RESEARCH CENTER, Inc.

    Anaheim, California, 92805

  • Michigan Clinical Research Institute

    Ann Arbor, Michigan, 48108

  • Emory

    Atlanta, Georgia, 30303

  • Synexus Clinical Research US

    Atlanta, Georgia, 30328

  • Community Clinical Research, Inc.

    Austin, Texas, 78754

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • CITrials

    Bellflower, California, 90706

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Synexus

    Cerritos, California, 90703

  • Uptown Research Institute

    Chicago, Illinois, 60640

  • CMB Clinical Trials

    Colton, California, 92324

  • ProScience Research Group

    Culver City, California, 90230

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • iResearch Atlanta

    Decatur, Georgia, 30030

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • Signature Research Associates Inc

    Fairlawn, Ohio, 44333

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Psychiatric Consultants, PC

    Franklin, Tennessee, 37067

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • Collaborative Neuroscience Network, LLC

    Garden Grove, California, 92845

  • Charak Clinical research Center

    Garfield Heights, Ohio, 44125

  • Behavioral Research Specialists, LLC

    Glendale, California, 91206

  • San Fernando Mental Health Center

    Granada Hills, California, 91344

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012

  • New Life medical Research Inc.

    Hialeah, Florida, 33012

  • Galiz Research

    Hialeah, Florida, 33016

  • AMITA Health

    Hoffman Estates, Illinois, 60169

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Synexus US

    Jamaica, New York, 11432

  • Lake Charles Clinical Trial

    Lake Charles, Louisiana, 70629

  • Om Research LLC

    Lancaster, California, 93534

  • Altea Research Institute

    Las Vegas, Nevada, 89102

  • Kolade Research Institute/Cal Psychiatric Services

    Las Vegas, Nevada, 89109

  • Innovative Clinical Research, Inc.

    Lauderhill, Florida, 33319

  • Synergy San Diego

    Lemon Grove, California, 91945

  • Alivation Research, LLC.

    Lincoln, Nebraska, 68526

  • Woodland International Research Group

    Little Rock, Arkansas, 72211

  • CalNeuro Research Group

    Los Angeles, California, 90024

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Premier Clinical Research Institute Inc.

    Miami, Florida, 33122

  • CCM Clinical Research Group

    Miami, Florida, 33133

  • Prestige Clinical Research Center Inc.

    Miami, Florida, 33133

  • Manhattan Psychiatric Center

    New York, New York, 10035

  • Manhattan Behavioral Medicine PLLC

    New York, New York, 10036

  • Neuro-Behavioral Clinical Research, Inc.

    North Canton, Ohio, 44720

  • Pacific Research Partners

    Oakland, California, 94607

  • Excell Research, Inc

    Oceanside, California, 92056

  • The Rivus Wellness & Research Institute

    Oklahoma City, Oklahoma, 73112

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116

  • Alea Research

    Phoenix, Arizona, 85012

  • CNRI-Los Angeles

    Pico Rivera, California, 90660

  • Prospective Research Innovations Inc.

    Rancho Cucamonga, California, 91730

  • Pillar Clinical Research

    Richardson, Texas, 75080

  • CITrials

    Riverside, California, 92506

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • CNRI-San Diego, LLC

    San Diego, California, 92102

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • CITrials, Inc.

    Santa Ana, California, 92705

  • Siyan Clinical Research

    Santa Rosa, California, 95401

  • iResearch Savannah

    Savannah, Georgia, 31405

  • SIU School of Medicine

    Springfield, Illinois, 62702

  • Noetic Psychiatry

    Springville, Utah, 84663

  • Arch Clinical Trials, LLC

    St Louis, Missouri, 63118

  • PsychCare Consultants Research

    St Louis, Missouri, 63128

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Stedman Clinical Tirlas

    Tampa, Florida, 33613

  • Collaborative Neuroscience Network, LLC

    Torrance, California, 90502

  • Nova Psychiatry, Inc

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: 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®.

Read the 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.

Conditions
Schizophrenia
Being tested
Abilify MyCite®
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abilify MyCite®Combination product

    Combination product of aripiprazole tablet embedded with sensor and wearable patch.

Study groups in NCT03892889
Study groupRoleWhat they receive
Abilify MyCite®ExperimentalParticipants 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.
Receives: Combination Product: Abilify MyCite®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Retrospective Period [Month -6 to Baseline (Day 1)] up to Prospective Period (Day 1 to Month 3)

Secondary outcomes (1)

  1. 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.

    Measured: Retrospective Period [-1 to -3 months prior to Baseline (Day 1)] up to Prospective Period (1 to 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2019
  2. Study start29 Apr 2019
  3. Primary completion12 Aug 2020
  4. Study completion29 Sep 2020

Why it stopped: Study has stopped for having met the primary endpoint.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03892889
Sponsor's protocol ID
031-201-00301
Status last verified
Aug 2021
First submitted
21 Mar 2019
Last updated
5 Sep 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: 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.

Publications

  • Jan M, Coppin-Renz A, West R, Gallo CL, Cochran JM, Heumen EV, Fahmy M, Reuteman-Fowler JC. Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials. JMIR Form Res. 2023 Dec 12;7:e44768. doi: 10.2196/44768.

    PubMed 38085556

  • 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.

    PubMed 35421287

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abilify MyCite® in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 68 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Inpatient Psychiatric Hospitalization (time frame: Retrospective Period [Month -6 to Baseline (Day 1)] up to Prospective Period (Day 1 to Month 3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03892889, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.

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