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

Schizophrenia Clinical Trial

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®

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03892889
• Other study ID #: 031-201-00301
• Status: Terminated
• Phase: Phase 3
• Start date: April 29, 2019
• Est. completion date: September 29, 2020

Study information

• Verified date: August 2021
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 277
• Est. completion date: September 29, 2020
• Est. primary completion date: August 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Combination Product:
• Abilify MyCite®
Combination product of aripiprazole tablet embedded with sensor and wearable patch.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Inpatient Psychiatric Hospitalization	Percentage of participants with inpatient psychiatric hospitalization in Prospective Period With at least one hospitalization in Retrospective Period.	Retrospective Period [Month -6 to Baseline (Day 1)] up to Prospective Period (Day 1 to Month 3)
Secondary	Percentage of Days With Improved Adherence	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.	Retrospective Period [-1 to -3 months prior to Baseline (Day 1)] up to Prospective Period (1 to 3 months)