Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole
NCT02219009 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2018-08-15
Summary
The purpose of this study is to determine the usability of the Medical Information Device #1 (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole.
Conditions
- Schizophrenia
- Mental Disorder
- Nervous System Diseases
Interventions
- DEVICE
-
MIND1 System
Subjects will receive aripiprazole tablets embedded with an IEM. They will discontinue their normally prescribed oral aripiprazole tablets and will take the aripiprazole + IEM tablets (eg, at the previously prescribed dose) during the 8-week treatment period for this study. Aripiprazole + IEM tablets must be taken on a once-daily dosing schedule.
Sponsors & Collaborators
-
Otsuka Pharmaceutical Development & Commercialization, Inc.
lead INDUSTRY
Principal Investigators
-
Timothy Peters-Strickland, MD · Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-08-31
- Primary Completion
- 2015-07-31
- Completion
- 2015-07-31
Countries
- United States
Study Locations
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