Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study

Schizophrenia Clinical Trial

— EMITTER3PSY  

Official title:

Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study (EMITTER 3.0 PSY)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01804257
• Other study ID #: EMITTER 3.0 PSY
• Status: Completed
• Phase: N/A
• First received: February 27, 2013
• Last updated: March 4, 2013
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: March 2013
• Source: Proteus Digital Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bipolar Disorder
• Schizophrenia

Intervention

Device:
• Digital Health Feedback System

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Zucker Hillside Hospital	Glen Oaks	New York

Sponsors (3)

Lead Sponsor	Collaborator
Proteus Digital Health, Inc.	Massachusetts General Hospital, The Zucker Hillside Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Taking and scheduling adherence	Characterize, using summary (descriptive) statistics, medication-taking behavior in free-living environment. Taking adherence defined as the number of ingestion sensors detected by the DHFS in the free-living environment, divided by the prescribed (planned) number of ingestions. Scheduling adherence defined as number of ingestion sensors detected by the DHFS within a ± 2-hour time window around the prescribed (planned) dosing time, divided by the total number of ingestion sensors detected by the DHFS.	4 weeks	No
Other	Biometrics	Characterize, using summary (descriptive) statistics, heart rate and rest/activity patterns in a free-living environment. Activity defined as the number of hours per day with recorded a recorded step rate = 60 steps per minute	4 weeks	No
Other	Usability	Characterize, using summary (descriptive) statistics, the use of the digital health feedback system and its components by patients, caregivers, and healthcare providers. Use captured utilizing numeric scores collected from a standardized instrument, focusing on overall comfort and ease of DHFS use.	4 weeks	No
Other	User experience	Feedback and suggestions from patients, caregivers, and healthcare providers regarding system metrics and summary presentations of medication-taking, biometrics, and activities of daily living. Feedback includes free text and descriptive statistics summarizing numeric scores collected from a standardized instrument focusing on overall satisfaction with the DHFS and its components.	4 weeks	No
Primary	Positive detection accuracy	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.	4 weeks	No
Secondary	System safety	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	4 weeks	Yes