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

Who is this study for? Patients with Schizophrenia
What treatments are being studied? ABILIFY MYCITE
Status: Terminated
Location: See all (68) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 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.

Locations
United States
Arkansas
Woodland International Research Group
Little Rock
Arizona
Alea Research
Phoenix
California
ADVANCED RESEARCH CENTER, Inc.
Anaheim
CITrials
Bellflower
Synexus
Cerritos
CMB Clinical Trials
Colton
ProScience Research Group
Culver City
Collaborative Neuroscience Network, LLC
Garden Grove
Behavioral Research Specialists, LLC
Glendale
San Fernando Mental Health Center
Granada Hills
Om Research LLC
Lancaster
Synergy San Diego
Lemon Grove
CalNeuro Research Group
Los Angeles
Pacific Research Partners
Oakland
Excell Research, Inc
Oceanside
CNRI-Los Angeles
Pico Rivera
Prospective Research Innovations Inc.
Rancho Cucamonga
CITrials
Riverside
Artemis Institute for Clinical Research
San Diego
CNRI-San Diego, LLC
San Diego
CITrials, Inc.
Santa Ana
Siyan Clinical Research
Santa Rosa
Collaborative Neuroscience Network, LLC
Torrance
Florida
Sarkis Clinical Trials
Gainesville
Galiz Research
Hialeah
Indago Research & Health Center, Inc.
Hialeah
New Life medical Research Inc.
Hialeah
Innovative Clinical Research, Inc.
Lauderhill
CCM Clinical Research Group
Miami
Premier Clinical Research Institute Inc.
Miami
Prestige Clinical Research Center Inc.
Miami
Stedman Clinical Tirlas
Tampa
Nova Psychiatry, Inc
Winter Park
Georgia
Emory
Atlanta
Synexus Clinical Research US
Atlanta
iResearch Atlanta
Decatur
iResearch Savannah
Savannah
Illinois
Uptown Research Institute
Chicago
AMITA Health
Hoffman Estates
SIU School of Medicine
Springfield
Louisiana
Lake Charles Clinical Trial
Lake Charles
Michigan
Michigan Clinical Research Institute
Ann Arbor
Missouri
Arch Clinical Trials, LLC
Saint Louis
PsychCare Consultants Research
Saint Louis
Mississippi
Precise Research Centers
Flowood
Nebraska
Alivation Research, LLC.
Lincoln
New Jersey
Hassman Research Institute
Berlin
Nevada
Altea Research Institute
Las Vegas
Kolade Research Institute/Cal Psychiatric Services
Las Vegas
New York
Synexus US
Jamaica
Manhattan Behavioral Medicine PLLC
New York
Manhattan Psychiatric Center
New York
Finger Lakes Clinical Research
Rochester
Richmond Behavioral Associates
Staten Island
Ohio
Midwest Clinical Research Center
Dayton
Signature Research Associates Inc
Fairlawn
Charak Clinical research Center
Garfield Heights
Neuro-Behavioral Clinical Research, Inc.
North Canton
Oklahoma
Cutting Edge Research Group
Oklahoma City
The Rivus Wellness & Research Institute
Oklahoma City
Pennsylvania
Suburban Research Associates
Media
Tennessee
Psychiatric Consultants, PC
Franklin
Texas
Community Clinical Research, Inc.
Austin
InSite Clinical Research
Desoto
Baylor College of Medicine
Houston
Pillar Clinical Research
Richardson
Utah
Noetic Psychiatry
Springville
Washington
Northwest Clinical Research Center
Bellevue
Time Frame
Start Date: 2019-04-29
Completion Date: 2020-09-29
Participants
Target number of participants: 277
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Otsuka Pharmaceutical Development & Commercialization, Inc.

This content was sourced from clinicaltrials.gov

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