Noninvasive Physiologic Sensors to Assess Depression

Completed

Conditions studied: Depression, Major Depressive Disorder

In brief

This project aims to use sensors to monitor physiological signals, sleep patterns, vocal characteristics, activity, location and phone usage in study patients with depression who are receiving standard treatment (compared with healthy controls).

Key facts

Study ID

NCT02568865

Run by

Massachusetts General Hospital

People needed

50

Starts

2016-01-15

Expected to finish

2020-01-03

Last updated by the study team

2020-02-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients with Depression (n=40):
• Adults (ages 18-75),
• Able to read, understand, and provide written informed consent in English,
• Meet criteria for a primary psychiatric diagnosis of major depressive disorder for ≥ 4 weeks, according to the M.I.N.I (Mini International Neuropsychiatric Interview),
• Hamilton Depression Rating Scale (HDRS) total score ≥ 18,
• Engaged in or willing to be referred for clinical care for depression treatment as usual (antidepressants and/or psychotherapy),
• Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
• Must own a working Android smartphone (Android 2.3+) and use it regularly,
• Must own a windows PC (or tablet) or a Mac computer (or laptop),
• Must have access to Internet service every day.
• Healthy Controls (n=10):
• Adults (ages 18-75),
• Able to read, understand, and provide written informed consent in English,
• Not meet criteria for past or current psychiatric illness, excluding specific phobias, as measured by the M.I.N.I.,
• Not have a first-degree relative with known major psychiatric illness including Major Depressive Disorder, Bipolar Disorder, Psychotic Disorder or Substance Use Disorder,
• Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
• Must own a working Android smartphone (Android 2.3+) and use it regularly,
• Must own a windows PC (or tablet) or a Mac computer (or laptop),
• Must have access to Internet service every day.
• Exclusion Criteria (for all subjects):
• Active drug or alcohol use disorder in the past 3 months,
• History of psychosis,
• History of mania or hypomania,
• Epilepsy or history of seizures,
• Untreated hypothyroidism,

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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