Sensor-based Characterization of Depression

Status unconfirmed

Conditions studied: Unipolar Depression

In brief

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 presence of depression as well as predict treatment response. Measurement-based treatment is considered optimal and the development of a valid passive, objective, behavioral and biological assessment of depressive symptoms that does not rely on clinician interviews will improve monitoring and ultimately improve treatment significantly.

Key facts

Study ID

NCT04370002

Run by

Massachusetts General Hospital

People needed

100

Starts

2020-01-28

Expected to finish

2024-11-30

Last updated by the study team

2023-11-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Depression Clinical Research Program — Boston, Massachusetts, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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