Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
60

Inclusion Criterias

If subject is on other psychotropic medications, he/she must be on a stable dose and regimen over the last 2 weeks.
Subjects must be able to tolerate blood draws.
Current primary Axis-1 diagnosis of bipolar 1 disorder or schizophrenia as defined by DSM-IV-TR criteria
...
If subject is on other psychotropic medications, he/she must be on a stable dose and regimen over the last 2 weeks.
Subjects must be able to tolerate blood draws.
Current primary Axis-1 diagnosis of bipolar 1 disorder or schizophrenia as defined by DSM-IV-TR 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.
Schizophrenia patients with a total PANSS score of 60 to 90 (inclusive)
Males and females 18 to 65 years of age, inclusive, at time of informed consent
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.
Bipolar 1 disorder patients with a total YMRS score of 10 to 25 (inclusive)
Currently prescribed oral Aripiprazole for either bipolar 1 disorder or schizophrenia. No changes in their Aripiprazole dose or regimen 2 weeks before screening.

Exclusion Criterias

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

Summary

Conditions
  • Bipolar 1 Disorder
  • Mental Disorder
  • Nervous System Diseases
  • Schizophrenia
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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 ...

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.

Inclusion Criterias

If subject is on other psychotropic medications, he/she must be on a stable dose and regimen over the last 2 weeks.
Subjects must be able to tolerate blood draws.
Current primary Axis-1 diagnosis of bipolar 1 disorder or schizophrenia as defined by DSM-IV-TR criteria
...
If subject is on other psychotropic medications, he/she must be on a stable dose and regimen over the last 2 weeks.
Subjects must be able to tolerate blood draws.
Current primary Axis-1 diagnosis of bipolar 1 disorder or schizophrenia as defined by DSM-IV-TR 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.
Schizophrenia patients with a total PANSS score of 60 to 90 (inclusive)
Males and females 18 to 65 years of age, inclusive, at time of informed consent
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.
Bipolar 1 disorder patients with a total YMRS score of 10 to 25 (inclusive)
Currently prescribed oral Aripiprazole for either bipolar 1 disorder or schizophrenia. No changes in their Aripiprazole dose or regimen 2 weeks before screening.

Exclusion Criterias

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

Locations

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

Tracking Information

NCT #
NCT01981811
Collaborators
Not Provided
Investigators
Study Director: Shashank Rohatagi, PhD Otsuka Pharmaceutical Development & Commercialization, Inc.