Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study

Not Applicable

Completed

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.

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.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Digital Health Feedback System (DHFS)	Digital Health Feedback System	Ingestion Sensor, Wearable Sensor

Primary Outcome Measures

Name	Time	Method
Positive Detection Accuracy	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
System Safety	8 weeks	Characterize, using summary (descriptive) statistics, the incidence and nature of system-related adverse events (AEs) and serious adverse events (SAEs) that are reported by study investigators over the course of the study

Locations (2): Zucker Hillside Hospital
🇺🇸
Glen Oaks, New York, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States