A Trial in Adult Participants With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®
NCT ID: NCT03892889
Last Updated: 2021-09-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
277 participants
INTERVENTIONAL
2019-04-29
2020-09-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Combination of Two Currently Approved Drugs to Enhance the Treatment of Schizophrenia
NCT00089869
A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia
NCT00888693
This Study Tests Whether BI 409306 Prevents Patients With Schizophrenia From Becoming Worse. This Study Looks at How Well Patients Tolerate BI 409306 and How Effective it is Over 6 Months
NCT03351244
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
NCT06894212
A Long-Term, Open-Label, Study on Schizophrenia
NCT01129674
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Abilify MyCite®
Combination product of aripiprazole tablet embedded with sensor and wearable patch.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abilify MyCite®
Combination product of aripiprazole tablet embedded with sensor and wearable patch.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Collaborative Neuroscience Network, LLC
Torrance, California, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, United States
New Life medical Research Inc.
Hialeah, Florida, United States
Galiz Research
Hialeah, Florida, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States
Premier Clinical Research Institute Inc.
Miami, Florida, United States
CCM Clinical Research Group
Miami, Florida, United States
Prestige Clinical Research Center Inc.
Miami, Florida, United States
Stedman Clinical Tirlas
Tampa, Florida, United States
Nova Psychiatry, Inc
Winter Park, Florida, United States
Emory
Atlanta, Georgia, United States
Synexus Clinical Research US
Atlanta, Georgia, United States
iResearch Atlanta
Decatur, Georgia, United States
iResearch Savannah
Savannah, Georgia, United States
Uptown Research Institute
Chicago, Illinois, United States
AMITA Health
Hoffman Estates, Illinois, United States
SIU School of Medicine
Springfield, Illinois, United States
Lake Charles Clinical Trial
Lake Charles, Louisiana, United States
Michigan Clinical Research Institute
Ann Arbor, Michigan, United States
Precise Research Centers
Flowood, Mississippi, United States
Arch Clinical Trials, LLC
St Louis, Missouri, United States
PsychCare Consultants Research
St Louis, Missouri, United States
Alivation Research, LLC.
Lincoln, Nebraska, United States
Altea Research Institute
Las Vegas, Nevada, United States
Kolade Research Institute/Cal Psychiatric Services
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Synexus US
Jamaica, New York, United States
Manhattan Psychiatric Center
New York, New York, United States
Manhattan Behavioral Medicine PLLC
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Signature Research Associates Inc
Fairlawn, Ohio, United States
Charak Clinical research Center
Garfield Heights, Ohio, United States
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, United States
The Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Suburban Research Associates
Media, Pennsylvania, United States
Psychiatric Consultants, PC
Franklin, Tennessee, United States
Community Clinical Research, Inc.
Austin, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Pillar Clinical Research
Richardson, Texas, United States
Noetic Psychiatry
Springville, Utah, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Alea Research
Phoenix, Arizona, United States
Woodland International Research Group
Little Rock, Arkansas, United States
ADVANCED RESEARCH CENTER, Inc.
Anaheim, California, United States
CITrials
Bellflower, California, United States
Synexus
Cerritos, California, United States
CMB Clinical Trials
Colton, California, United States
ProScience Research Group
Culver City, California, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States
Behavioral Research Specialists, LLC
Glendale, California, United States
San Fernando Mental Health Center
Granada Hills, California, United States
Om Research LLC
Lancaster, California, United States
Synergy San Diego
Lemon Grove, California, United States
CalNeuro Research Group
Los Angeles, California, United States
Pacific Research Partners
Oakland, California, United States
Excell Research, Inc
Oceanside, California, United States
CNRI-Los Angeles
Pico Rivera, California, United States
Prospective Research Innovations Inc.
Rancho Cucamonga, California, United States
CITrials
Riverside, California, United States
CNRI-San Diego, LLC
San Diego, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
CITrials, Inc.
Santa Ana, California, United States
Siyan Clinical Research
Santa Rosa, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
031-201-00301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.