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

Stopped early · Phase 3

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT03892889

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

277

Starts

2019-04-29

Expected to finish

2020-09-29

Last updated by the study team

2021-09-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• Collaborative Neuroscience Network, LLC — Torrance, California, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Indago Research & Health Center, Inc. — Hialeah, Florida, United States
• Alea Research — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.