A Trial in Adult Participants With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®
- Conditions
- Schizophrenia
- Interventions
- Combination Product: Abilify MyCite®
- Registration Number
- NCT03892889
- Brief Summary
To compare inpatient psychiatric hospitalization rates while participants are on oral standard-of-care antipsychotic treatment and later switched to Abilify MyCite®.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 277
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Abilify MyCite® 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Inpatient Psychiatric Hospitalization Retrospective Period [Month -6 to Baseline (Day 1)] up to Prospective Period (Day 1 to Month 3) Percentage of participants with inpatient psychiatric hospitalization in Prospective Period With at least one hospitalization in Retrospective Period.
- Secondary Outcome Measures
Name Time Method 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) 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.
Related Research Topics
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Trial Locations
- Locations (66)
CMB Clinical Trials
🇺🇸Colton, California, United States
Excell Research, Inc
🇺🇸Oceanside, California, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Siyan Clinical Research
🇺🇸Santa Rosa, California, United States
PsychCare Consultants Research
🇺🇸Saint Louis, Missouri, United States
Charak Clinical research Center
🇺🇸Garfield Heights, Ohio, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Signature Research Associates Inc
🇺🇸Fairlawn, Ohio, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Synergy San Diego
🇺🇸Lemon Grove, California, United States
Synexus US
🇺🇸Jamaica, New York, United States
InSite Clinical Research
🇺🇸DeSoto, Texas, United States
Manhattan Behavioral Medicine PLLC
🇺🇸New York, New York, United States
Community Clinical Research, Inc.
🇺🇸Austin, Texas, United States
Woodland International Research Group
🇺🇸Little Rock, Arkansas, United States
Synexus
🇺🇸Cerritos, California, United States
Pacific Research Partners
🇺🇸Oakland, California, United States
SIU School of Medicine
🇺🇸Springfield, Illinois, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Noetic Psychiatry
🇺🇸Springville, Utah, United States
Psychiatric Consultants, PC
🇺🇸Franklin, Tennessee, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
CITrials
🇺🇸Riverside, California, United States
Collaborative Neuroscience Network, LLC
🇺🇸Torrance, California, United States
Om Research LLC
🇺🇸Lancaster, California, United States
CalNeuro Research Group
🇺🇸Los Angeles, California, United States
CNRI-Los Angeles
🇺🇸Pico Rivera, California, United States
Indago Research & Health Center, Inc.
🇺🇸Hialeah, Florida, United States
Galiz Research
🇺🇸Hialeah, 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
Alivation Research, LLC.
🇺🇸Lincoln, Nebraska, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Neuro-Behavioral Clinical Research, Inc.
🇺🇸North Canton, Ohio, 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
CNRI-San Diego, LLC
🇺🇸San Diego, California, United States
Altea Research Institute
🇺🇸Las Vegas, Nevada, United States
Kolade Research Institute/Cal Psychiatric Services
🇺🇸Las Vegas, Nevada, United States
ADVANCED RESEARCH CENTER, Inc.
🇺🇸Anaheim, California, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
ProScience Research Group
🇺🇸Culver City, California, United States
San Fernando Mental Health Center
🇺🇸Granada Hills, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
New Life medical Research Inc.
🇺🇸Hialeah, Florida, United States
Arch Clinical Trials, LLC
🇺🇸Saint Louis, Missouri, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Pillar Clinical Research
🇺🇸Richardson, Texas, United States
Manhattan Psychiatric Center
🇺🇸New York, New York, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Alea Research
🇺🇸Phoenix, Arizona, United States
The Rivus Wellness & Research Institute
🇺🇸Oklahoma City, Oklahoma, United States
Cutting Edge Research Group
🇺🇸Oklahoma City, Oklahoma, United States
CITrials, Inc.
🇺🇸Santa Ana, California, United States
Prospective Research Innovations Inc.
🇺🇸Rancho Cucamonga, California, United States
Michigan Clinical Research Institute
🇺🇸Ann Arbor, Michigan, United States
Stedman Clinical Tirlas
🇺🇸Tampa, Florida, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Lake Charles Clinical Trial
🇺🇸Lake Charles, Louisiana, United States
AMITA Health
🇺🇸Hoffman Estates, Illinois, United States