Trials / Completed
CompletedNCT01804257
Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study
Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study (EMITTER 3.0 PSY)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Proteus Digital Health, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Feasibility study of using a digital health feedback system (DHFS) to monitor medication-taking and physiologic and behavioral parameters in patients with bipolar disorder or schizophrenia. Hypothesis: Using a digital health feedback system to characterize medication-taking behavior and activities of daily living is safe and tolerable in appropriately selected patients with bipolar disorder and schizophrenia.
Detailed description
In this 4-week observational study conducted between May 2010 and May 2011 at 2 US academic clinical study sites, 12 adults with bipolar disorder and 16 adults with schizophrenia (all diagnosed according to DSM-IV criteria) utilized a digital health feedback system (DHFS). All subjects were on a stable regimen of oral medication. The DHFS utilized a digital tablet, consisting of an ingestion sensor that was embedded in a tablet containing nonpharmacologic excipients, which subjects coingested with their regularly prescribed medication. The primary study objective was to compare the accuracy of DHFS in confirming digital tablet ingestion versus a method of directly observed ingestion; secondary aims included characterization of adherence and physiologic measures longitudinally in these cohorts.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Digital Health Feedback System | The digital health offering passively collects and records medication-taking behavior and other habits of daily living |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2011-05-01
- Completion
- 2011-05-01
- First posted
- 2013-03-05
- Last updated
- 2017-06-16
- Results posted
- 2017-06-16
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01804257. Inclusion in this directory is not an endorsement.