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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Aripiprazole
* Device: Ingestible Event Marker (IEM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aripiprazole and Ingestible Event Marker (IEM)<br>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<br> <br> Device: Ingestible Event Marker (IEM)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | 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 |  | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OPC-14597 Digital, Aripiprazole, Medical Information Device #1 System (MIND1), Treatment Adherence, Ingestible Event Marker