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Adherence to Treatment, Safety and Tolerability Study of the Medical Information Device #1 (MIND1) in Subjects With Schizophrenia or Bipolar I Disorder

Primary Purpose

Bipolar 1 Disorder, Schizophrenia, Mental Disorder

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Aripiprazole

Ingestible Event Marker (IEM)

About this trial

This is an interventional treatment trial for Bipolar 1 Disorder focused on measuring OPC-14597 Digital, Aripiprazole, Medical Information Device #1 System (MIND1), Treatment Adherence, Ingestible Event Marker

Eligibility Criteria

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

Inclusion Criteria:

Males and females 18 to 65 years of age, inclusive, at time of informed consent
Schizophrenia: Patients with two or more exacerbations of symptoms in past year leading to an intervention, per investigator's judgment (ie, inpatient psychiatric hospitalization, psychiatric ER visit, admission to partial hospitalization program, crisis residential treatment, etc.). This does not include outpatient adjustment of medication.
Bipolar I Disorder: Patients with at least one manic episode or exacerbation of bipolar symptoms in past year resulting in an intervention, per Investigator's judgment (i.e., inpatient psychiatric hospitalization, psychiatric ER visit, admission to partial hospitalization program, crisis residential treatment, etc.) This does not include outpatient adjustment of medication.
Current primary Axis-1 diagnosis of bipolar 1 disorder or schizophrenia as defined by DSM-IV-TR criteria
Bipolar 1 disorder patients with a total YMRS score of 10 to 25 (inclusive)
Schizophrenia patients with a total PANSS score of 60 to 90 (inclusive)
Currently prescribed oral Aripiprazole for either bipolar 1 disorder or schizophrenia. No changes in their Aripiprazole dose or regimen 2 weeks before screening.
Subjects must be able to tolerate blood draws.
If subject is on other psychotropic medications, he/she must be on a stable dose and regimen over the last 2 weeks.

Exclusion Criteria:

Subjects with a current Axis I (DSM-IV-TR) diagnosis other than bipolar 1 disorder or schizophrenia
Subjects with a current Axis II (DSM-IV-TR) diagnosis
History of inpatient hospitalization for any psychiatric reason within 2 months before screening
Subjects who reside or attend a facility where medication is administered to them
Subject has received any investigational product within the last 30 days
Allergic, intolerant, or unresponsive to prior treatment with Aripiprazole or other quinolinones
History of hypersensitivity to antipsychotic agents

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Aripiprazole and Ingestible Event Marker (IEM)

Arm Description

All subjects will continue to receive their previously prescribed dose of aripiprazole (10 mg, 15 mg, 20 mg, or 30 mg) through the trial. Subjects will discontinue dosing of the conventional oral aripiprazole tablet and will begin taking MIND1 (aripiprazole embedded with an Ingestible Event Marker) tablet once-daily for 12 weeks.

Outcomes

Primary Outcome Measures

Medication adherence, as defined by the number of IEM detections reported by the MIND1 System divided by the medication doses prescribed.

Secondary Outcome Measures

Compliance, defined as the ratio of individual model-predicted exposure (AUC) at Week 12 following administration of oral aripiprazole using the MIND1 System versus the expected exposure

Full Information

NCT ID

NCT01981811

First Posted

October 22, 2013

Last Updated

April 27, 2015

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01981811

Brief Title

Adherence to Treatment, Safety and Tolerability Study of the Medical Information Device #1 (MIND1) in Subjects With Schizophrenia or Bipolar I Disorder

Official Title

A Single-arm Study to Evaluate Adherence to Treatment With, and Safety and Tolerability of, the Medical Information Device #1 (MIND1) System in Subjects With Schizophrenia or Bipolar I Disorder Who Are Currently Treated With Oral Aripiprazole

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Withdrawn

Why Stopped

The trial was terminated because it was determined that the usability of the MIND1 System in the intended population was necessary before conducting this trial.

Study Start Date

March 2014 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate adherence to treatment with, and safety and tolerability of, the medical information device #1 (MIND1) system in subjects with Schizophrenia or Bipolar I Disorder who are currently treated with oral aripiprazole.

Detailed Description

Poor adherence to medication is a well-recognized problem in psychiatric patients and is a barrier to achieving optimal health. The MIND1 System is being developed to objectively and precisely monitor and measure real-time medication adherence; and to potentially enhance adherence. The MIND1 System includes oral aripiprazole with an embedded ingestible event marker (IEM), a Wearable Sensor, and a computerized device and accessories. This is a trial designed to evaluate adherence to treatment with, and safety and tolerability of, the medical information device #1 (MIND1) system in subjects with schizophrenia or bipolar I disorder. This 12-week, single-arm trial will include male and female subjects 18 to 65years (inclusive) with a current diagnosis of schizophrenia or bipolar I disorder who are currently treated with oral aripiprazole.

6. Conditions and Keywords

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

Bipolar 1 Disorder, Schizophrenia, Mental Disorder, Nervous System Diseases

Keywords

OPC-14597 Digital, Aripiprazole, Medical Information Device #1 System (MIND1), Treatment Adherence, Ingestible Event Marker

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aripiprazole and Ingestible Event Marker (IEM)

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Aripiprazole

Intervention Type

Device

Intervention Name(s)

Ingestible Event Marker (IEM)

Primary Outcome Measure Information:

Title

Medication adherence, as defined by the number of IEM detections reported by the MIND1 System divided by the medication doses prescribed.

Time Frame

Baseline to Week 12

Secondary Outcome Measure Information:

Title

Compliance, defined as the ratio of individual model-predicted exposure (AUC) at Week 12 following administration of oral aripiprazole using the MIND1 System versus the expected exposure

Time Frame

Week 12

Other Pre-specified Outcome Measures:

Title

Comparison of the predicted PK exposure (log transformed-area under the plasma concentration-time curve [AUC]) at Week 12 to the predicted PK exposure prior to use of the MIND1 System

Time Frame

Week 12

Title

Change in compliance, defined as the difference in predicted adherence at Week 12 and the predicted adherence before using the MIND1 System

Time Frame

Week 12

Title

Proportion of subjects who achieve greater than 80% compliance post-Week 12 administration of aripiprazole through MIND1

Time Frame

Baseline to Week 12

Title

Severity of illness, defined by the change from Screening/baseline to Week 12 with scores on the CGI-scale, PSP, SLOF, PANSS and YMRS.

Time Frame

Screening/baseline to Week 12

Title

Safety and tolerability: frequency and severity of AEs; frequency of serious AEs; AEs leading to discontinuation; and frequency and severity of unexpected adverse events and unanticipated device adverse events (UDAE)

Time Frame

Baseline to Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and females 18 to 65 years of age, inclusive, at time of informed consent Schizophrenia: Patients with two or more exacerbations of symptoms in past year leading to an intervention, per investigator's judgment (ie, inpatient psychiatric hospitalization, psychiatric ER visit, admission to partial hospitalization program, crisis residential treatment, etc.). This does not include outpatient adjustment of medication. Bipolar I Disorder: Patients with at least one manic episode or exacerbation of bipolar symptoms in past year resulting in an intervention, per Investigator's judgment (i.e., inpatient psychiatric hospitalization, psychiatric ER visit, admission to partial hospitalization program, crisis residential treatment, etc.) This does not include outpatient adjustment of medication. Current primary Axis-1 diagnosis of bipolar 1 disorder or schizophrenia as defined by DSM-IV-TR criteria Bipolar 1 disorder patients with a total YMRS score of 10 to 25 (inclusive) Schizophrenia patients with a total PANSS score of 60 to 90 (inclusive) Currently prescribed oral Aripiprazole for either bipolar 1 disorder or schizophrenia. No changes in their Aripiprazole dose or regimen 2 weeks before screening. Subjects must be able to tolerate blood draws. If subject is on other psychotropic medications, he/she must be on a stable dose and regimen over the last 2 weeks. Exclusion Criteria: Subjects with a current Axis I (DSM-IV-TR) diagnosis other than bipolar 1 disorder or schizophrenia Subjects with a current Axis II (DSM-IV-TR) diagnosis History of inpatient hospitalization for any psychiatric reason within 2 months before screening Subjects who reside or attend a facility where medication is administered to them Subject has received any investigational product within the last 30 days Allergic, intolerant, or unresponsive to prior treatment with Aripiprazole or other quinolinones History of hypersensitivity to antipsychotic agents

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shashank Rohatagi, PhD

Organizational Affiliation

Otsuka Pharmaceutical Development & Commercialization, Inc.

Official's Role

Study Director

Facility Information:

City

Cerritos

State/Province

California

ZIP/Postal Code

90703

Country

United States

City

Garden Grove

State/Province

California

ZIP/Postal Code

92845

Country

United States

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

City

National City

State/Province

California

ZIP/Postal Code

91950

Country

United States

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63118

Country

United States

City

Marlton

State/Province

New Jersey

ZIP/Postal Code

08053

Country

United States

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

City

Irving

State/Province

Texas

ZIP/Postal Code

75062

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Adherence to Treatment, Safety and Tolerability Study of the Medical Information Device #1 (MIND1) in Subjects With Schizophrenia or Bipolar I Disorder

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