Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Schizophrenia, Major Depression Disorder (MDD), Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/25/2018 |
| Start Date: | March 2016 |
| End Date: | September 2016 |
A Multicenter, 8-week, Open-label, Single-Arm Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System by Adult Subjects With Schizophrenia, Major Depressive Disorder, or Bipolar 1 Treated With Oral Aripiprazole
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.
Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or
Bipolar Disorder taking oral aripiprazole.
The Digital Medicine System includes a drug-device combination of aripiprazole + an
ingestible event marker (IEM), a wearable sensor (skin patch), and application software to
convey the level of activity and rest, and to mark events through the act of ingestion.
Physician and self-report are the most commonly used to assess medication compliance yet
studies have consistently found that healthcare providers' subjective judgments of medication
compliance are often inaccurate, with a tendency for practitioners to overestimate subject
adherence. The sponsor's intent is to develop a system that will benefit future subjects by
providing the ability to measure their medication-taking behavior in an objective manner and
being able to monitor several physiologic parameters.
ingestible event marker (IEM), a wearable sensor (skin patch), and application software to
convey the level of activity and rest, and to mark events through the act of ingestion.
Physician and self-report are the most commonly used to assess medication compliance yet
studies have consistently found that healthcare providers' subjective judgments of medication
compliance are often inaccurate, with a tendency for practitioners to overestimate subject
adherence. The sponsor's intent is to develop a system that will benefit future subjects by
providing the ability to measure their medication-taking behavior in an objective manner and
being able to monitor several physiologic parameters.
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
We found this trial at
4
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials