Status:
UNKNOWN
Sensor-based Characterization of Depression
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Massachusetts Institute of Technology
Conditions:
Unipolar Depression
Eligibility:
All Genders
18-75 years
Brief Summary
This is a longitudinal study where individual with Major Depressive Disorder (MDD) will be monitored for 12 weeks. The study aims to develop an objective, sensor-based, algorithm able to detect the pr...
Detailed Description
In this longitudinal study 100 individuals with Major Depressive Disorder (MDD) will be monitored for 12 weeks. Data will include self-report surveys, in-person assessments, physiological features der...
Eligibility Criteria
Inclusion
- Adults (ages 18-75),
- Able to read, understand, and provide written informed consent in English,
- Meet criteria for a primary psychiatric diagnosis of current major depressive disorder
- Hamilton Depression Rating Scale (HDRS) total score ≥ 18,
- Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
- Must own a working smartphone 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.
- Must have started antidepressant medications, changed medication dosage, or started therapy within 3 weeks
Exclusion
- Active drug or alcohol use disorder in the past 3 months,
- History of psychotic disorder,
- History of mania or hypomania,
- Epilepsy or history of Seizure Disorder (including PNES), narcolepsy, Alzheimer Disease, Parkinson's Disease, ALS, Severe TBI, Dementia, MS, Cerebral Palsy, and Neuralgia.
- Untreated hypothyroidism,
- Unstable medical disease,
- Cognitive impairment that would impede adherence to study procedures,
- Acute suicide or homicide risk,
- Current treatment with electroconvulsive therapy, vagal nerve stimulation therapy, deep brain stimulation, transcranial magnetic stimulation therapy, or phototherapy,
- Cannot comprehend or communicate in English,
- Lack of working smartphone or lack of daily access to Internet service,
- Inability to measure skin conductance/electrodermal activity (as assessed at the screening visit), and
- Inability or unwilling to, at minimum, wear the physiological sensor (E4) wristbands, download monitoring apps, and fill out the surveys.
- Participants with more than two treatment failures (more than two adequate trials of meds on the basis of ATRQ) in the current mood episode.
Key Trial Info
Start Date :
January 28 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04370002
Start Date
January 28 2020
End Date
November 30 2024
Last Update
November 3 2023
Active Locations (2)
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1
Depression Clinical Research Program
Boston, Massachusetts, United States, 02114
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114