Bipolar 1 Disorder, Mental Disorder, Nervous System Diseases, Schizophrenia
Conditions
Keywords
OPC-14597 Digital, Aripiprazole, Medical Information Device #1 System (MIND1), Treatment Adherence, Ingestible Event Marker
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.
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.
Interventions
DRUGAripiprazole
DEVICEIngestible Event Marker (IEM)
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| 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 | Week 12 |
Other
| Measure | Time frame |
|---|---|
| Proportion of subjects who achieve greater than 80% compliance post-Week 12 administration of aripiprazole through MIND1 | Baseline to Week 12 |
| 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 |
| 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 |
| 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 |
| Change in compliance, defined as the difference in predicted adherence at Week 12 and the predicted adherence before using the MIND1 System | Week 12 |
Countries
United States
Outcome results
None listed