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

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01981811

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar 1 Disorder Schizophrenia Mental Disorder Nervous System Diseases	Drug: Aripiprazole Device: Ingestible Event Marker (IEM)	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2014

Actual Primary Completion Date :

May 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Medication adherence, as defined by the number of IEM detections reported by the MIND1 System divided by the medication doses prescribed. [Baseline to Week 12]

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 [Week 12]

Other Outcome Measures

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 [Week 12]
Change in compliance, defined as the difference in predicted adherence at Week 12 and the predicted adherence before using the MIND1 System [Week 12]
Proportion of subjects who achieve greater than 80% compliance post-Week 12 administration of aripiprazole through MIND1 [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. [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) [Baseline to Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Cerritos	California	United States	90703
2	Garden Grove	California	United States	92845
3	Long Beach	California	United States	90813
4	National City	California	United States	91950
5	Oceanside	California	United States	92056
6	San Diego	California	United States	92123
7	Washington	District of Columbia	United States	20016
8	Atlanta	Georgia	United States	30308
9	St Louis	Missouri	United States	63118
10	Marlton	New Jersey	United States	08053
11	Dayton	Ohio	United States	45417
12	Irving	Texas	United States	75062