Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2016-01-15
2020-01-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Major Depressive Disorder
Physiological Sensors
Wearable biosensors can play an important role in depression diagnosis. For this study, we will use a cost-effective, unobtrusive, and non-stigmatizing sensor to monitor physiological signals (including heart rate (HR), heart rate variability (HRV), electrodermal activity (EDA), physical activity, and temperature).
Sleep Monitoring Device
The X4 Device is an internally battery powered FDA-classified Type BF device used for configurable acquisition of physiological signals via EEG.
Vocal Monitoring
The participants will be provided with a phone app to leave audio diary recordings.
Mobile Phone
A mobile phone and tablet will be used for various purposes, including, recording of socialization, location, and activity patterns of participants and to collect emotional information based on interactive surveys, as well as for forwarding sleep and physiological sensor measurements to a secure server.
Healthy Volunteers
Physiological Sensors
Wearable biosensors can play an important role in depression diagnosis. For this study, we will use a cost-effective, unobtrusive, and non-stigmatizing sensor to monitor physiological signals (including heart rate (HR), heart rate variability (HRV), electrodermal activity (EDA), physical activity, and temperature).
Sleep Monitoring Device
The X4 Device is an internally battery powered FDA-classified Type BF device used for configurable acquisition of physiological signals via EEG.
Vocal Monitoring
The participants will be provided with a phone app to leave audio diary recordings.
Mobile Phone
A mobile phone and tablet will be used for various purposes, including, recording of socialization, location, and activity patterns of participants and to collect emotional information based on interactive surveys, as well as for forwarding sleep and physiological sensor measurements to a secure server.
Interventions
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Physiological Sensors
Wearable biosensors can play an important role in depression diagnosis. For this study, we will use a cost-effective, unobtrusive, and non-stigmatizing sensor to monitor physiological signals (including heart rate (HR), heart rate variability (HRV), electrodermal activity (EDA), physical activity, and temperature).
Sleep Monitoring Device
The X4 Device is an internally battery powered FDA-classified Type BF device used for configurable acquisition of physiological signals via EEG.
Vocal Monitoring
The participants will be provided with a phone app to leave audio diary recordings.
Mobile Phone
A mobile phone and tablet will be used for various purposes, including, recording of socialization, location, and activity patterns of participants and to collect emotional information based on interactive surveys, as well as for forwarding sleep and physiological sensor measurements to a secure server.
Eligibility Criteria
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Inclusion Criteria
1. Adults (ages 18-75),
2. Able to read, understand, and provide written informed consent in English,
3. 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),
4. Hamilton Depression Rating Scale (HDRS) total score ≥ 18,
5. Engaged in or willing to be referred for clinical care for depression treatment as usual (antidepressants and/or psychotherapy),
6. Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
7. Must own a working Android smartphone (Android 2.3+) and use it regularly,
8. Must own a windows PC (or tablet) or a Mac computer (or laptop),
9. Must have access to Internet service every day.
Healthy Controls (n=10):
1. Adults (ages 18-75),
2. Able to read, understand, and provide written informed consent in English,
3. Not meet criteria for past or current psychiatric illness, excluding specific phobias, as measured by the M.I.N.I.,
4. Not have a first-degree relative with known major psychiatric illness including Major Depressive Disorder, Bipolar Disorder, Psychotic Disorder or Substance Use Disorder,
5. Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
6. Must own a working Android smartphone (Android 2.3+) and use it regularly,
7. Must own a windows PC (or tablet) or a Mac computer (or laptop),
8. Must have access to Internet service every day.
Exclusion Criteria
2. History of psychosis,
3. History of mania or hypomania,
4. Epilepsy or history of seizures,
5. Untreated hypothyroidism,
6. Unstable medical disease,
7. Cognitive impairment that would impede adherence to study procedures,
8. Acute suicide or homicide risk,
9. Current treatment with electroconvulsive therapy, vagal nerve stimulation therapy, deep brain stimulation, transcranial magnetic stimulation therapy, or phototherapy,
10. Concurrent participation in other research studies,
11. Cannot comprehend or communicate in English,
12. Lack of working smartphone or lack of daily access to Internet service,
13. Inability to measure skin conductance/electrodermal activity (as assessed at the screening visit), and
14. Inability or unwilling to, at minimum, wear the physiological sensor (E4) bands, fill out the surveys, and record a weekly diary.
18 Years
70 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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David Mischoulon, MD, PhD
Director, Depression Clinical and Research Program
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2015P001913
Identifier Type: -
Identifier Source: org_study_id
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