Clinical trial NCT01804257: Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study
Official title: Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study (EMITTER 3.0 PSY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Schizophrenia
Keywords: Adherence
Bipolar disorder
Cellular phone
Cloud computing
Computers
Computers, handheld
Digital health
Digital health feedback system
Ingestion Sensor
Medication adherence
Medication non-adherence
Medication nonadherence
Mobile phone
Mobile health
Patient adherence
Patient non-adherence
Patient nonadherence
Schizophrenia
Telehealth
Telemedicine
Telenursing
Wearable sensor
Lead sponsor: Proteus Digital Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
name: The Zucker Hillside Hospital
First posted: 2013-03-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive Detection Accuracy
timeFrame: 4 weeks
Secondary outcomes:
measure: System Safety
timeFrame: 8 weeks
Other outcomes:
measure: Taking and Scheduling Adherence
timeFrame: 4 weeks
measure: Biometrics
timeFrame: 4 weeks
measure: Usability
timeFrame: 4 weeks
measure: User Experience
timeFrame: 4 weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Glen Oaks
country: United States
facility: Zucker Hillside Hospital
state: New York
Study officials:
affiliation: The Zucker Hillside Hospital
name: John M Kane, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.