Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medici… (NCT02722967) | Clinical Trial Compass
CompletedPhase 2
Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
United States49 participantsStarted 2016-03
Plain-language summary
This study will assess the helpfulness of the integrated call center in optimizing use of the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder taking oral aripiprazole.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Primary diagnosis of Schizophrenia (SCH), Major Depressive Disorder (MDD), or Bipolar 1 Disorder (BP1), per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* Must be able to swallow tablets
* Currently taking a stable daily dose of oral aripiprazole
* Must have capacity to utilize the technology
* Skin in area of patch application must be free of any skin disorders or dermatological problems
Exclusion Criteria:
* Subjects using long acting injectable antipsychotic medications
* Subjects likely to be incapable of using the Digital Medicine System even with assistance
* Subjects who present serious risk of suicide
* History of epilepsy or seizures
* History of hypersensitivity to antipsychotic agents, adhesive tape or any component of the sensor skin patch or ingestible event marker
* Current history of substance use disorder meeting DSM-5 criteria
* Subject with unstable mood, acute psychosis or exhibiting symptoms requiring hospitalization
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of the Functionality of an Integrated Call Center for DMS by Adult Subjects With SCH, MDD, or BP1 Who Were Treated With Oral Aripiprazole.
Timeframe: From baseline upto week 9
Trial details
NCT IDNCT02722967
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.