Sensor-based Characterization of Depression

NCT04370002 | Unknown

• 1 other identifier: 2019P000997
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Unipolar Depression

Keywords

Depression; Sensors

Outcome Measures

Primary Outcomes (1)

• The Hamilton Depression Rating Scale (HDRS) 17-items

  The HDRS-17 is a clinician-based assessment of depressive symptoms. Higher scores indicate worse symptoms. Total score can range from 0 to 53.

  Past week.

Secondary Outcomes (1)

• Patient Health Questionnaire 9 (PHQ-9)

  Past 7 days

Study Arms (1)

No Intervention

This is an observational study. There is no active treatment that is examined.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be individuals with Major Depressive Disorder

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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Massachusetts Institute of Technology: collaborator

Study Sites (2)

Depression Clinical Research Program

Boston, Massachusetts, 02114, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 30, 2020
• Study Start: January 28, 2020
• Primary Completion: September 1, 2024
• Study Completion: November 30, 2024
• Last Updated: November 3, 2023

Record last verified: 2023-11

Locations

US (2)