Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study

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.

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