Phase 2
Completed N=49
Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
Source: ClinicalTrials.gov NCT02722967 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: 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. — 0; 0; 1; 8 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
0; 0; 1; 8; 8; 9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02722967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.