Status:
COMPLETED
Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study
Lead Sponsor:
Proteus Digital Health, Inc.
Collaborating Sponsors:
Massachusetts General Hospital
The Zucker Hillside Hospital
Conditions:
Bipolar Disorder
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 accord...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01804257
Start Date
May 1 2010
End Date
May 1 2011
Last Update
June 16 2017
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02116
2
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004