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

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03892889
• Collaborator: (none)
• Enrollment: 277
• Locations: 68
• Arm: 1
• Actual Duration (Months): 17.1
• Patients Per Site: 4.1
• Patients Per Site Per Month: 0.2

Study Details

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®.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Combination Product: Abilify MyCite®	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 277 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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®
• Actual Study Start Date: Apr 29, 2019
• Actual Primary Completion Date: Aug 12, 2020
• Actual Study Completion Date: Sep 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.	Combination Product: Abilify MyCite®; Combination product of aripiprazole tablet embedded with sensor and wearable patch.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alea Research	Phoenix	Arizona	United States	85012
2	Woodland International Research Group	Little Rock	Arkansas	United States	72211
3	ADVANCED RESEARCH CENTER, Inc.	Anaheim	California	United States	92805
4	CITrials	Bellflower	California	United States	90706
5	Synexus	Cerritos	California	United States	90703
6	CMB Clinical Trials	Colton	California	United States	92324
7	ProScience Research Group	Culver City	California	United States	90230
8	Collaborative Neuroscience Network, LLC	Garden Grove	California	United States	92845
9	Behavioral Research Specialists, LLC	Glendale	California	United States	91206
10	San Fernando Mental Health Center	Granada Hills	California	United States	91344
11	Om Research LLC	Lancaster	California	United States	93534
12	Synergy San Diego	Lemon Grove	California	United States	91945
13	CalNeuro Research Group	Los Angeles	California	United States	90024
14	Pacific Research Partners	Oakland	California	United States	94607
15	Excell Research, Inc	Oceanside	California	United States	92056
16	CNRI-Los Angeles	Pico Rivera	California	United States	90660
17	Prospective Research Innovations Inc.	Rancho Cucamonga	California	United States	91730
18	CITrials	Riverside	California	United States	92506
19	CNRI-San Diego, LLC	San Diego	California	United States	92102
20	Artemis Institute for Clinical Research	San Diego	California	United States	92103
21	CITrials, Inc.	Santa Ana	California	United States	92705
22	Siyan Clinical Research	Santa Rosa	California	United States	95401
23	Collaborative Neuroscience Network, LLC	Torrance	California	United States	90502
24	Sarkis Clinical Trials	Gainesville	Florida	United States	32607
25	Indago Research & Health Center, Inc.	Hialeah	Florida	United States	33012
26	New Life medical Research Inc.	Hialeah	Florida	United States	33012
27	Galiz Research	Hialeah	Florida	United States	33016
28	Innovative Clinical Research, Inc.	Lauderhill	Florida	United States	33319
29	Premier Clinical Research Institute Inc.	Miami	Florida	United States	33122
30	CCM Clinical Research Group	Miami	Florida	United States	33133
31	Prestige Clinical Research Center Inc.	Miami	Florida	United States	33133
32	Stedman Clinical Tirlas	Tampa	Florida	United States	33613
33	Nova Psychiatry, Inc	Winter Park	Florida	United States	32789
34	Emory	Atlanta	Georgia	United States	30303
35	Synexus Clinical Research US	Atlanta	Georgia	United States	30328
36	iResearch Atlanta	Decatur	Georgia	United States	30030
37	iResearch Savannah	Savannah	Georgia	United States	31405
38	Uptown Research Institute	Chicago	Illinois	United States	60640
39	AMITA Health	Hoffman Estates	Illinois	United States	60169
40	SIU School of Medicine	Springfield	Illinois	United States	62702
41	Lake Charles Clinical Trial	Lake Charles	Louisiana	United States	70629
42	Michigan Clinical Research Institute	Ann Arbor	Michigan	United States	48108
43	Precise Research Centers	Flowood	Mississippi	United States	39232
44	Arch Clinical Trials, LLC	Saint Louis	Missouri	United States	63118
45	PsychCare Consultants Research	Saint Louis	Missouri	United States	63128
46	Alivation Research, LLC.	Lincoln	Nebraska	United States	68526
47	Altea Research Institute	Las Vegas	Nevada	United States	89102
48	Kolade Research Institute/Cal Psychiatric Services	Las Vegas	Nevada	United States	89109
49	Hassman Research Institute	Berlin	New Jersey	United States	08009
50	Synexus US	Jamaica	New York	United States	11432
51	Manhattan Psychiatric Center	New York	New York	United States	10035
52	Manhattan Behavioral Medicine PLLC	New York	New York	United States	10036
53	Finger Lakes Clinical Research	Rochester	New York	United States	14618
54	Richmond Behavioral Associates	Staten Island	New York	United States	10312
55	Midwest Clinical Research Center	Dayton	Ohio	United States	45417
56	Signature Research Associates Inc	Fairlawn	Ohio	United States	44333
57	Charak Clinical research Center	Garfield Heights	Ohio	United States	44125
58	Neuro-Behavioral Clinical Research, Inc.	North Canton	Ohio	United States	44720
59	The Rivus Wellness & Research Institute	Oklahoma City	Oklahoma	United States	73112
60	Cutting Edge Research Group	Oklahoma City	Oklahoma	United States	73116
61	Suburban Research Associates	Media	Pennsylvania	United States	19063
62	Psychiatric Consultants, PC	Franklin	Tennessee	United States	37067
63	Community Clinical Research, Inc.	Austin	Texas	United States	78754
64	InSite Clinical Research	DeSoto	Texas	United States	75115
65	Baylor College of Medicine	Houston	Texas	United States	77030
66	Pillar Clinical Research	Richardson	Texas	United States	75080
67	Noetic Psychiatry	Springville	Utah	United States	84663
68	Northwest Clinical Research Center	Bellevue	Washington	United States	98007

Sponsors and Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Feb 11, 2019
• Statistical Analysis Plan - Oct 28, 2020

More Information

Publications

None provided.

• Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
• ClinicalTrials.gov Identifier: NCT03892889
• Other Study ID Numbers: 031-201-00301
• First Posted: Mar 27, 2019
• Last Update Posted: Sep 5, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Additional relevant MeSH terms: Schizophrenia; Aripiprazole

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 58 investigative sites in the United States from 29 April 2019 to 12 August 2020.
Pre-assignment Detail	Participants who were on oral standard-of-care antipsychotic treatments for a period of 6 months prior to Baseline (Day 1) were assessed retrospectively and were enrolled in the Prospective Period on Day 1 to receive Abilify MyCite® for a period of 3 months (Months 1 to 3) and to continue with same treatment or standard of care up to Month 6.

Arm/Group Title	Abilify MyCite®
Arm/Group 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.
Period Title: Overall Study
STARTED	277
COMPLETED	73
NOT COMPLETED	204

Baseline Characteristics

Arm/Group Title	Abilify MyCite®
Arm/Group 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.
Overall Participants	277
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	44.2 (12.4)
Sex: Female, Male (Count of Participants)
Female	95 34.3%
Male	182 65.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	52 18.8%
Not Hispanic or Latino	223 80.5%
Unknown or Not Reported	2 0.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	4 1.4%
Asian	5 1.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	167 60.3%
White	98 35.4%
More than one race	0 0%
Unknown or Not Reported	3 1.1%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (mITT) Sample included data from all participants entering the prospective phase who have completed the first 3-months of dosing on Abilify MyCite®.

Arm/Group Title	Abilify MyCite®
Arm/Group 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.
Measure Participants	113
Number [percentage of participants]	0.0 0%

2. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

ITT Sample included all enrolled sample who met the study inclusion/exclusion criteria and who are intended to receive study medication in the Prospective Phase. Overall number analyzed is the number of participants with confirmed retrospective prescription data to conduct the PDC calculation.

Arm/Group Title	Abilify MyCite®
Arm/Group 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.
Measure Participants	162
PDC in Retrospective Period	51.0 (37.9)
PDC in Prospective Period	77.5 (31.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abilify MyCite®
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Paired t-test was used based on the prospective phase efficacy sample when applicable.
	Method	paired t-test
	Comments

Adverse Events

Time Frame	Up to 6 months
Arm/Group Title	Abilify MyCite®
Arm/Group 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.
All Cause Mortality
	Abilify MyCite®
	Affected / at Risk (%)	# Events
Total	1/277 (0.4%)
Serious Adverse Events
	Abilify MyCite®
	Affected / at Risk (%)	# Events
Total	6/277 (2.2%)
Gastrointestinal disorders
Pancreatitis Acute	1/277 (0.4%)
Immune system disorders
Drug Hypersensitivity	1/277 (0.4%)
Infections and infestations
Pneumonia Bacterial	1/277 (0.4%)
Nervous system disorders
Cerebrovascular Accident	1/277 (0.4%)
Psychiatric disorders
Schizophrenia	2/277 (0.7%)
Other (Not Including Serious) Adverse Events
	Abilify MyCite®
	Affected / at Risk (%)	# Events
Total	0/277 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.