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

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Abilify MyCite®
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alea Research
  • Woodland International Research Group
  • ADVANCED RESEARCH CENTER, Inc.
  • CITrials
  • Synexus
  • CMB Clinical Trials
  • ProScience Research Group
  • Collaborative Neuroscience Network, LLC
  • Behavioral Research Specialists, LLC
  • San Fernando Mental Health Center
  • Om Research LLC
  • Synergy San Diego
  • CalNeuro Research Group
  • Pacific Research Partners
  • Excell Research, Inc
  • CNRI-Los Angeles
  • Prospective Research Innovations Inc.
  • CITrials
  • CNRI-San Diego, LLC
  • Artemis Institute for Clinical Research
  • CITrials, Inc.
  • Siyan Clinical Research
  • Collaborative Neuroscience Network, LLC
  • Sarkis Clinical Trials
  • Indago Research & Health Center, Inc.
  • New Life medical Research Inc.
  • Galiz Research
  • Innovative Clinical Research, Inc.
  • Premier Clinical Research Institute Inc.
  • CCM Clinical Research Group
  • Prestige Clinical Research Center Inc.
  • Stedman Clinical Tirlas
  • Nova Psychiatry, Inc
  • Emory
  • Synexus Clinical Research US
  • iResearch Atlanta
  • iResearch Savannah
  • Uptown Research Institute
  • AMITA Health
  • SIU School of Medicine
  • Lake Charles Clinical Trial
  • Michigan Clinical Research Institute
  • Precise Research Centers
  • Arch Clinical Trials, LLC
  • PsychCare Consultants Research
  • Alivation Research, LLC.
  • Altea Research Institute
  • Kolade Research Institute/Cal Psychiatric Services
  • Hassman Research Institute
  • Synexus US
  • Manhattan Psychiatric Center
  • Manhattan Behavioral Medicine PLLC
  • Finger Lakes Clinical Research
  • Richmond Behavioral Associates
  • Midwest Clinical Research Center
  • Signature Research Associates Inc
  • Charak Clinical research Center
  • Neuro-Behavioral Clinical Research, Inc.
  • The Rivus Wellness & Research Institute
  • Cutting Edge Research Group
  • Suburban Research Associates
  • Psychiatric Consultants, PC
  • Community Clinical Research, Inc.
  • InSite Clinical Research
  • Baylor College of Medicine
  • Pillar Clinical Research
  • Noetic Psychiatry
  • Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abilify MyCite®

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 21, 2019
Last Updated
August 10, 2021
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03892889
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Study has stopped for having met the primary endpoint.
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
August 12, 2020 (Actual)
Study Completion Date
September 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abilify MyCite®
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Abilify MyCite®
Intervention Description
Combination product of aripiprazole tablet embedded with sensor and wearable patch.
Primary Outcome Measure Information:
Title
Percentage of Participants With Inpatient Psychiatric Hospitalization
Description
Percentage of participants with inpatient psychiatric hospitalization in Prospective Period With at least one hospitalization in Retrospective Period.
Time Frame
Retrospective Period [Month -6 to Baseline (Day 1)] up to Prospective Period (Day 1 to Month 3)
Secondary Outcome Measure Information:
Title
Percentage of Days With Improved Adherence
Description
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.
Time Frame
Retrospective Period [-1 to -3 months prior to Baseline (Day 1)] up to Prospective Period (1 to 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Alea Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
ADVANCED RESEARCH CENTER, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
CITrials
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Synexus
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
CMB Clinical Trials
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
San Fernando Mental Health Center
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
Om Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Synergy San Diego
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
CalNeuro Research Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Pacific Research Partners
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Excell Research, Inc
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
CNRI-Los Angeles
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Prospective Research Innovations Inc.
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
CITrials
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
CNRI-San Diego, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
CITrials, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Siyan Clinical Research
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95401
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Indago Research & Health Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
New Life medical Research Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Galiz Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Innovative Clinical Research, Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Premier Clinical Research Institute Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
CCM Clinical Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Prestige Clinical Research Center Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Stedman Clinical Tirlas
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Nova Psychiatry, Inc
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Emory
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Synexus Clinical Research US
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
iResearch Savannah
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Uptown Research Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
AMITA Health
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
SIU School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Lake Charles Clinical Trial
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Michigan Clinical Research Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Arch Clinical Trials, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
PsychCare Consultants Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Alivation Research, LLC.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Altea Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Kolade Research Institute/Cal Psychiatric Services
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Synexus US
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Manhattan Psychiatric Center
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
Manhattan Behavioral Medicine PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Signature Research Associates Inc
City
Fairlawn
State/Province
Ohio
ZIP/Postal Code
44333
Country
United States
Facility Name
Charak Clinical research Center
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
Facility Name
Neuro-Behavioral Clinical Research, Inc.
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
The Rivus Wellness & Research Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Cutting Edge Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Psychiatric Consultants, PC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Community Clinical Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pillar Clinical Research
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Noetic Psychiatry
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
IPD Sharing Time Frame
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
IPD Sharing Access Criteria
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
IPD Sharing URL
https://clinical-trials.otsuka.com
Citations:
PubMed Identifier
35421287
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.
Results Reference
derived

Learn more about this trial

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

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