A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03643159
• Collaborator: (none)
• Enrollment: 2
• Locations: 5
• Arms: 2
• Actual Duration (Months): 3.6
• Patients Per Site: 0.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary objective of this pragmatic clinical trial (Main Study) was to assess the difference between all-cause hospitalizations in participants using Abilify MyCite versus virtual matched controls. In addition, secondary and exploratory objectives were to assess medication adherence, healthcare utilization and costs, and patient-reported outcomes.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Bipolar 1 Disorder; Major Depressive Disorder	Combination Product: Abilify MyCite - Digital Medicine System; Drug: Aripiprazole or other oral antipsychotics	Phase 4

Detailed Description

This was a phase 4, open-label, prospective, pragmatic clinical trial to assess the difference between all-cause hospitalizations in participants using Abilify MyCite (for Months 1-3, then prohibited for Months 4-6) versus virtual matched controls from baseline to Day 180. Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which was oral aripiprazole or any other product). Eligible participants entered a screening period of up to 13 days. For participants enrolling into the study, those not on aripiprazole at screening used the screening period for conversion to aripiprazole from other antipsychotics. Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis.

After the visit at Day 180, a second, optional interventional period (up to 6 months of Abilify MyCite) could have been initiated per the joint decision of the participants with their study physician; participants in this second, optional interventional period were to have a visit at Day 360. During this second, optional interventional period, participants may have started and stopped Abilify MyCite as clinically indicated.

A parallel exploratory study that would utilize a different set of physicians and participants from the main study was planned; however, that study was never initiated.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: A Multicenter, 180-day Pragmatic Clinical Trial to Measure the Difference in All-cause Hospitalizations for Patients Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder
• Actual Study Start Date: Jun 28, 2018
• Actual Primary Completion Date: Oct 17, 2018
• Actual Study Completion Date: Oct 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abilify MyCite Participants received Abilify MyCite during Months 1-3. During Months 4-6 use of Abilify MyCite was to be prohibited. Thereafter, at Day 180, a second, optional interventional period (up to 6 months of Abilify MyCite) could have been initiated per the joint decision of the participants with their study physician.	Combination Product: Abilify MyCite - Digital Medicine System; The Abilify MyCite system is a drug-device combination product comprised of aripiprazole (an atypical antipsychotic) tablets embedded with a sensor that communicates with a patch (wearable sensor) and a medical software application with collected information (ingestion, mood, activity, rest) tracked and summarized for participants, healthcare providers, and potential caregivers. Abilify MyCite is intended to track drug ingestion and is indicated for the treatment of adults with schizophrenia (SCH), bipolar 1 disorder (BP1) (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with major depressive disorder (MDD).; Drug: Aripiprazole or other oral antipsychotics; For the treatment of adults with SCH, BP1 (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with MDD.
Active Comparator: Virtual Matched Controls Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which could have been oral aripiprazole or any other product) throughout the duration of the trial. Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis.	Drug: Aripiprazole or other oral antipsychotics; For the treatment of adults with SCH, BP1 (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with MDD.

Outcome Measures

Primary Outcome Measures

1. Difference In The Number Of Participants With All-cause Hospitalizations For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180 [Baseline through Day 180]

   This outcome measure describes the difference in all-cause hospitalizations (that is hospitalizations for any reason) between the number of participants using Abilify MyCite and those receiving treatment as usual (the virtual matched controls). Due to early study termination, efficacy data were not collected.

Secondary Outcome Measures

1. Difference In The Number Of Participants With At Least 80% Proportion Of Days Covered (PDC) (With Antipsychotic Medication) For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180 [Baseline through Day 180]

   This outcome measure describes the difference in the number of participants with at least 80% PDC (with antipsychotic medication) between those using Abilify MyCite and those receiving treatment as usual (the virtual matched controls). Due to early study termination, efficacy data were not collected.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 63 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants are actively enrolled in an Anthem-affiliated commercial, Medicaid, or Medicare health plan with medical and pharmacy benefits.

• Participants must have a smartphone with data plan.

• Participants currently prescribed aripiprazole, or appropriate for aripiprazole treatment.

• Participants must have a current diagnosis of SCH, BP1, or MDD.

Exclusion Criteria:

• Any participant who participated in another clinical trial within 30 days of enrollment into the current study.

• Females who are breast-feeding and/or who are pregnant at the time of study enrollment, or who plan to become pregnant during the study.

• Participants who are currently being treated with a long-acting injectable antipsychotic.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Siyan Clinical Research	Santa Rosa	California	United States	95401
2	Psychiatric Addiction Curative/PACT Atlanta LLC	Decatur	Georgia	United States	30030
3	Georgia Psychiatry and Sleep	Smyrna	Georgia	United States	30080
4	Kolade Research Institute	Las Vegas	Nevada	United States	89109
5	Signature Research Associates, Inc.	Fairlawn	Ohio	United States	44333

Sponsors and Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Mar 8, 2018
• Statistical Analysis Plan - Oct 11, 2019

More Information

Publications

None provided.

• Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
• ClinicalTrials.gov Identifier: NCT03643159
• Other Study ID Numbers: 316-13-217
• First Posted: Aug 22, 2018
• Last Update Posted: Nov 8, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.: Digital Medicine System
• Additional relevant MeSH terms: Disease; Schizophrenia; Depressive Disorder; Depression; Depressive Disorder, Major; Aripiprazole; Antipsychotic Agents

Study Results

Participant Flow

Pre-assignment Detail	Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis. Since the study was terminated early, no matching occurred.

Arm/Group Title	Abilify MyCite
Arm/Group Description	Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol.
Period Title: Overall Study
STARTED	2
Received At Least 1 Dose Of Study Drug	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Abilify MyCite	Virtual Matched Controls	Total
Arm/Group Description	Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol.	Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which could have been oral aripiprazole or any other product) throughout the duration of the trial. Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis.	Total of all reporting groups
Overall Participants	2	0	2
Age (Count of Participants)
<=18 years	0 0%	0 NaN	0 0%
Between 18 and 65 years	0 0%	0 NaN	0 0%
>=65 years	0 0%	0 NaN	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 NaN	0 0%
Male	0 0%	0 NaN	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 NaN	0 0%
Not Hispanic or Latino	0 0%	0 NaN	0 0%
Unknown or Not Reported	0 0%	0 NaN	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 NaN	0 0%
Asian	0 0%	0 NaN	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 NaN	0 0%
Black or African American	0 0%	0 NaN	0 0%
White	0 0%	0 NaN	0 0%
More than one race	0 0%	0 NaN	0 0%
Unknown or Not Reported	0 0%	0 NaN	0 0%

Outcome Measures

1. Primary Outcome

Title	Difference In The Number Of Participants With All-cause Hospitalizations For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180
Description	This outcome measure describes the difference in all-cause hospitalizations (that is hospitalizations for any reason) between the number of participants using Abilify MyCite and those receiving treatment as usual (the virtual matched controls). Due to early study termination, efficacy data were not collected.
Time Frame	Baseline through Day 180

Outcome Measure Data

Analysis Population Description

Efficacy Analysis: All participants who received at least 1 dose of Abilify MyCite or who were a virtual matched control and had efficacy data. Both participants were excluded from efficacy analysis because they discontinued study therapy early. In addition, efficacy data were not collected due to early study termination.

Arm/Group Title	Abilify MyCite	Virtual Matched Controls
Arm/Group Description	Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol.	Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which could have been oral aripiprazole or any other product) throughout the duration of the trial. Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis.
Measure Participants	0	0

2. Secondary Outcome

Title	Difference In The Number Of Participants With At Least 80% Proportion Of Days Covered (PDC) (With Antipsychotic Medication) For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180
Description	This outcome measure describes the difference in the number of participants with at least 80% PDC (with antipsychotic medication) between those using Abilify MyCite and those receiving treatment as usual (the virtual matched controls). Due to early study termination, efficacy data were not collected.
Time Frame	Baseline through Day 180

Outcome Measure Data

Analysis Population Description

Efficacy Analysis: All participants who received at least 1 dose of Abilify MyCite or who were a virtual matched control and had efficacy data. Both participants were excluded from efficacy analysis because they discontinued study therapy early. In addition, efficacy data were not collected due to early study termination.

Arm/Group Title	Abilify MyCite	Virtual Matched Controls
Arm/Group Description	Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol.	Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which could have been oral aripiprazole or any other product) throughout the duration of the trial. Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis.
Measure Participants	0	0

Adverse Events

Time Frame	Baseline (Day 0) to Day 49
Adverse Event Reporting Description	The 2 enrolled participants both received Abilify MyCite. According to protocol, serious and other adverse events were not to be assessed for Virtual Matched Controls.
Arm/Group Title	Abilify MyCite
Arm/Group Description	Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol.
All Cause Mortality
	Abilify MyCite
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Abilify MyCite
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Abilify MyCite
	Affected / at Risk (%)	# Events
Total	1/2 (50%)
Skin and subcutaneous tissue disorders
Rash	1/2 (50%)

Limitations/Caveats

This study was terminated by the Sponsor due to difficulty in participant recruitment, leading to a small number of participants enrolled. Due to early termination of the study, no efficacy data were collected.

More Information

Certain Agreements

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

Sponsor reserves the right to review, edit, and authorize publications.