Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study

Completed · Not applicable

Conditions studied: Bipolar Disorder, Schizophrenia

In brief

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.

Key facts

Study ID

NCT01804257

Run by

Proteus Digital Health, Inc.

People needed

28

Starts

2010-05-01

Expected to finish

2011-05-01

Last updated by the study team

2017-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Zucker Hillside Hospital — Glen Oaks, New York, United States

Full record on ClinicalTrials.gov

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