Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bipolar Disorder Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Digital Health Feedback System (DHFS)

Ingestion Sensor, Wearable Sensor

Group Type EXPERIMENTAL

Digital Health Feedback System

Intervention Type OTHER

The digital health offering passively collects and records medication-taking behavior and other habits of daily living

Interventions

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Digital Health Feedback System

The digital health offering passively collects and records medication-taking behavior and other habits of daily living

Intervention Type OTHER

Other Intervention Names

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Ingestible sensor Wearable sensor

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No