Study Stopped
Study has stopped for having met the primary endpoint.
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®
1 other identifier
interventional
277
1 country
68
Brief Summary
To compare inpatient psychiatric hospitalization rates while participants are on oral standard-of-care antipsychotic treatment and later switched to Abilify MyCite®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started Apr 2019
Shorter than P25 for phase_3 schizophrenia
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2019
CompletedFirst Posted
Study publicly available on registry
March 27, 2019
CompletedStudy Start
First participant enrolled
April 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2020
CompletedResults Posted
Study results publicly available
September 5, 2021
CompletedSeptember 5, 2021
August 1, 2021
1.3 years
March 21, 2019
August 10, 2021
August 10, 2021
Conditions
Outcome Measures
Primary Outcomes (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.
Retrospective Period [Month -6 to Baseline (Day 1)] up to Prospective Period (Day 1 to Month 3)
Secondary Outcomes (1)
Percentage of Days With Improved Adherence
Retrospective Period [-1 to -3 months prior to Baseline (Day 1)] up to Prospective Period (1 to 3 months)
Study Arms (1)
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.
Interventions
Combination product of aripiprazole tablet embedded with sensor and wearable patch.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
Alea Research
Phoenix, Arizona, 85012, United States
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
ADVANCED RESEARCH CENTER, Inc.
Anaheim, California, 92805, United States
CITrials
Bellflower, California, 90706, United States
Synexus
Cerritos, California, 90703, United States
CMB Clinical Trials
Colton, California, 92324, United States
ProScience Research Group
Culver City, California, 90230, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, 92845, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
San Fernando Mental Health Center
Granada Hills, California, 91344, United States
Om Research LLC
Lancaster, California, 93534, United States
Synergy San Diego
Lemon Grove, California, 91945, United States
CalNeuro Research Group
Los Angeles, California, 90024, United States
Pacific Research Partners
Oakland, California, 94607, United States
Excell Research, Inc
Oceanside, California, 92056, United States
CNRI-Los Angeles
Pico Rivera, California, 90660, United States
Prospective Research Innovations Inc.
Rancho Cucamonga, California, 91730, United States
CITrials
Riverside, California, 92506, United States
CNRI-San Diego, LLC
San Diego, California, 92102, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
CITrials, Inc.
Santa Ana, California, 92705, United States
Siyan Clinical Research
Santa Rosa, California, 95401, United States
Collaborative Neuroscience Network, LLC
Torrance, California, 90502, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, 33012, United States
New Life medical Research Inc.
Hialeah, Florida, 33012, United States
Galiz Research
Hialeah, Florida, 33016, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319, United States
Premier Clinical Research Institute Inc.
Miami, Florida, 33122, United States
CCM Clinical Research Group
Miami, Florida, 33133, United States
Prestige Clinical Research Center Inc.
Miami, Florida, 33133, United States
Stedman Clinical Tirlas
Tampa, Florida, 33613, United States
Nova Psychiatry, Inc
Winter Park, Florida, 32789, United States
Emory
Atlanta, Georgia, 30303, United States
Synexus Clinical Research US
Atlanta, Georgia, 30328, United States
iResearch Atlanta
Decatur, Georgia, 30030, United States
iResearch Savannah
Savannah, Georgia, 31405, United States
Uptown Research Institute
Chicago, Illinois, 60640, United States
AMITA Health
Hoffman Estates, Illinois, 60169, United States
SIU School of Medicine
Springfield, Illinois, 62702, United States
Lake Charles Clinical Trial
Lake Charles, Louisiana, 70629, United States
Michigan Clinical Research Institute
Ann Arbor, Michigan, 48108, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Arch Clinical Trials, LLC
St Louis, Missouri, 63118, United States
PsychCare Consultants Research
St Louis, Missouri, 63128, United States
Alivation Research, LLC.
Lincoln, Nebraska, 68526, United States
Altea Research Institute
Las Vegas, Nevada, 89102, United States
Kolade Research Institute/Cal Psychiatric Services
Las Vegas, Nevada, 89109, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Synexus US
Jamaica, New York, 11432, United States
Manhattan Psychiatric Center
New York, New York, 10035, United States
Manhattan Behavioral Medicine PLLC
New York, New York, 10036, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Signature Research Associates Inc
Fairlawn, Ohio, 44333, United States
Charak Clinical research Center
Garfield Heights, Ohio, 44125, United States
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, 44720, United States
The Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, 73112, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Psychiatric Consultants, PC
Franklin, Tennessee, 37067, United States
Community Clinical Research, Inc.
Austin, Texas, 78754, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Pillar Clinical Research
Richardson, Texas, 75080, United States
Noetic Psychiatry
Springville, Utah, 84663, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Related Publications (2)
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.
PMID: 38085556DERIVEDCohen 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.
PMID: 35421287DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Development
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2019
First Posted
March 27, 2019
Study Start
April 29, 2019
Primary Completion
August 12, 2020
Study Completion
September 29, 2020
Last Updated
September 5, 2021
Results First Posted
September 5, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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
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.