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

April 27, 2015 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cerritos, California, United States, 90703
      • Garden Grove, California, United States, 92845
      • Long Beach, California, United States, 90813
      • National City, California, United States, 91950
      • Oceanside, California, United States, 92056
      • San Diego, California, United States, 92123
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
    • Georgia
      • Atlanta, Georgia, United States, 30308
    • Missouri
      • St Louis, Missouri, United States, 63118
    • New Jersey
      • Marlton, New Jersey, United States, 08053
    • Ohio
      • Dayton, Ohio, United States, 45417
    • Texas
      • Irving, Texas, United States, 75062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Aripiprazole and Ingestible Event Marker (IEM)
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.
Drug: Aripiprazole
Device: Ingestible Event Marker (IEM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Week 12

Other Outcome Measures

Outcome Measure
Time Frame
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
Week 12
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
Week 12
Proportion of subjects who achieve greater than 80% compliance post-Week 12 administration of aripiprazole through MIND1
Time Frame: Baseline to Week 12
Baseline to Week 12
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
Screening/baseline to Week 12
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
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

  • Study Director: Shashank Rohatagi, PhD, Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (ESTIMATE)

November 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 316-13-211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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