Clinical trial NCT03892889: A Trial in Adult Participants With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®
Official title: A Phase IIIb Multi-Center, Open-Label, Mirror-Image, Trial in Adult Subjects With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-27
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With Inpatient Psychiatric Hospitalization
timeFrame: Retrospective Period [Month -6 to Baseline (Day 1)] up to Prospective Period (Day 1 to Month 3)
Secondary outcomes:
measure: Percentage of Days With Improved Adherence
timeFrame: Retrospective Period [-1 to -3 months prior to Baseline (Day 1)] up to Prospective Period (1 to 3 months)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Alea Research
state: Arizona
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Anaheim
country: United States
facility: ADVANCED RESEARCH CENTER, Inc.
state: California
city: Bellflower
country: United States
facility: CITrials
state: California
city: Cerritos
country: United States
facility: Synexus
state: California
city: Colton
country: United States
facility: CMB Clinical Trials
state: California
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Granada Hills
country: United States
facility: San Fernando Mental Health Center
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Los Angeles
country: United States
facility: CalNeuro Research Group
state: California
city: Oakland
country: United States
facility: Pacific Research Partners
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc
state: California
city: Pico Rivera
country: United States
facility: CNRI-Los Angeles
state: California
city: Rancho Cucamonga
country: United States
facility: Prospective Research Innovations Inc.
state: California
city: Riverside
country: United States
facility: CITrials
state: California
city: San Diego
country: United States
facility: CNRI-San Diego, LLC
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Santa Ana
country: United States
facility: CITrials, Inc.
state: California
city: Santa Rosa
country: United States
facility: Siyan Clinical Research
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc.
state: Florida
city: Hialeah
country: United States
facility: New Life medical Research Inc.
state: Florida
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute Inc.
state: Florida
city: Miami
country: United States
facility: CCM Clinical Research Group
state: Florida
city: Miami
country: United States
facility: Prestige Clinical Research Center Inc.
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Tirlas
state: Florida
city: Winter Park
country: United States
facility: Nova Psychiatry, Inc
state: Florida
city: Atlanta
country: United States
facility: Emory
state: Georgia
city: Atlanta
country: United States
facility: Synexus Clinical Research US
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Savannah
country: United States
facility: iResearch Savannah
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute
state: Illinois
city: Hoffman Estates
country: United States
facility: AMITA Health
state: Illinois
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trial
state: Louisiana
city: Ann Arbor
country: United States
facility: Michigan Clinical Research Institute
state: Michigan
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Saint Louis
country: United States
facility: Arch Clinical Trials, LLC
state: Missouri
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Lincoln
country: United States
facility: Alivation Research, LLC.
state: Nebraska
city: Las Vegas
country: United States
facility: Altea Research Institute
state: Nevada
city: Las Vegas
country: United States
facility: Kolade Research Institute/Cal Psychiatric Services
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Jamaica
country: United States
facility: Synexus US
state: New York
city: New York
country: United States
facility: Manhattan Psychiatric Center
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine PLLC
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Fairlawn
country: United States
facility: Signature Research Associates Inc
state: Ohio
city: Garfield Heights
country: United States
facility: Charak Clinical research Center
state: Ohio
city: North Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: The Rivus Wellness & Research Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Franklin
country: United States
facility: Psychiatric Consultants, PC
state: Tennessee
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Richardson
country: United States
facility: Pillar Clinical Research
state: Texas
city: Springville
country: United States
facility: Noetic Psychiatry
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
References:
citation: 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.