Adherence to Treatment, Safety and Tolerability Study of the Medical Information Device #1 (MIND1) in Subjects With Schizophrenia or Bipolar I Disorder
NCT ID: NCT01981811
Last Updated: 2015-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2014-03-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Aripiprazole
Ingestible Event Marker (IEM)
Interventions
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Aripiprazole
Ingestible Event Marker (IEM)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shashank Rohatagi, PhD
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Development & Commercialization, Inc.
Locations
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Cerritos, California, United States
Garden Grove, California, United States
Long Beach, California, United States
National City, California, United States
Oceanside, California, United States
San Diego, California, United States
Washington D.C., District of Columbia, United States
Atlanta, Georgia, United States
St Louis, Missouri, United States
Marlton, New Jersey, United States
Dayton, Ohio, United States
Irving, Texas, United States
Countries
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Other Identifiers
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316-13-211
Identifier Type: -
Identifier Source: org_study_id
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