Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study
EMITTER3PSY
1 other identifier
interventional
28
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 27, 2013
CompletedFirst Posted
Study publicly available on registry
March 5, 2013
CompletedResults Posted
Study results publicly available
June 16, 2017
CompletedJune 16, 2017
March 1, 2013
1 year
February 27, 2013
September 15, 2015
April 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positive Detection Accuracy
Comparison of the detection rate of sensor-enabled placebo tablet ingestion using wireless observation (wirelessly observed therapy) to directly observed ingestion. Positive detection accuracy (PDA) for wirelessly observed therapy defined as the number of sensor ingestions detected by wireless observation, divided by the number confirmed ingestions using direct observation. PDA summarized as mean and 95% confidence interval.
4 weeks
Secondary Outcomes (1)
System Safety
8 weeks
Other Outcomes (4)
Taking and Scheduling Adherence
4 weeks
Biometrics
4 weeks
Usability
4 weeks
- +1 more other outcomes
Study Arms (1)
Digital Health Feedback System (DHFS)
EXPERIMENTALIngestion Sensor, Wearable Sensor
Interventions
The digital health offering passively collects and records medication-taking behavior and other habits of daily living
Eligibility Criteria
You may qualify if:
- Male or female ≥ 18 and ≤ 65 years of age
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria, by Structured Clinical Interview using DSM-IV SCID-I/P1, for either:
- i. Bipolar disorder I, II, or Not Otherwise Specified (NOS), or ii. Schizophrenia or schizoaffective disorder
- Clinical global impression scale-severity (CGI-S) of 3 or below
- Currently on a stable regimen of oral antimanic or antipsychotic medication for at least 3 months
- No anticipation to change or titrate the regimen in the next 28 days
- Willingness to adhere to study procedures
- Capacity to provide informed consent
You may not qualify if:
- Pregnancy, or women of child bearing potential who are not using a medically accepted means of contraception
- Serious suicide or homicide risk, as assessed by evaluating clinician
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
- DSM-IV diagnoses or symptoms of substance use disorders, active within the last 60 days
- A score of 3 or higher on the suspiciousness/paranoia item of the Brief Psychiatric Rating Scale (BPRS)
- Acute, clinically significant gastrointestinal symptoms, such as nausea, vomiting, abdominal pain, diarrhea, melena, or hematochezia
- History of significant gastrointestinal disease or major gastrointestinal surgery
- Clinical instability of any kind that, in the investigator's opinion, could preclude safe participation in the study
- Known allergies that could preclude safe participation in the study
- Current presence of an electronically active implanted medical device
- Participation in another medical device study, or on any investigational drug or device within the last 30 days
- Inability to obtain consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Proteus Digital Health, Inc.lead
- Massachusetts General Hospitalcollaborator
- The Zucker Hillside Hospitalcollaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02116, United States
Zucker Hillside Hospital
Glen Oaks, New York, 11004, United States
Related Publications (1)
Kane JM, Perlis RH, DiCarlo LA, Au-Yeung K, Duong J, Petrides G. First experience with a wireless system incorporating physiologic assessments and direct confirmation of digital tablet ingestions in ambulatory patients with schizophrenia or bipolar disorder. J Clin Psychiatry. 2013 Jun;74(6):e533-40. doi: 10.4088/JCP.12m08222.
PMID: 23842023RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- John M. Kane MD
- Organization
- Zucker Hillside Hospital, Glen Oaks, NY
Study Officials
- PRINCIPAL INVESTIGATOR
John M Kane, MD
The Zucker Hillside Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2013
First Posted
March 5, 2013
Study Start
May 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
June 16, 2017
Results First Posted
June 16, 2017
Record last verified: 2013-03