Sensor-based Characterization of Depression

Launched by MASSACHUSETTS GENERAL HOSPITAL · Apr 28, 2020

Keywords

ClinConnect Summary

This clinical trial, called "Sensor-based Characterization of Depression," is studying how to better detect and predict treatment responses for individuals with Major Depressive Disorder (MDD) using sensors. Over a period of 12 weeks, participants will wear a device that measures their physiological responses, helping researchers understand depression in a more objective way without relying solely on interviews with doctors. This could lead to improved monitoring and treatment for depression.

To participate, you need to be an adult between 18 and 75 years old who can read and understand English, and currently have a diagnosis of major depressive disorder with a specific level of symptom severity. You should also own and regularly use a smartphone and have access to the internet. The study will involve wearing a wristband sensor and completing surveys on your experiences. It’s important to know that certain medical conditions and treatments may exclude you from joining the study, so it's best to check if you meet all the criteria. Overall, this trial aims to enhance how we understand and treat depression, potentially leading to better outcomes for those affected.

Gender

ALL

Eligibility criteria

• 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 current major depressive disorder
• • 4. Hamilton Depression Rating Scale (HDRS) total score ≥ 18,
• • 5. Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
• • 6. Must own a working smartphone 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.
• • 9. Must have started antidepressant medications, changed medication dosage, or started therapy within 3 weeks
• Exclusion Criteria:
• • 1. Active drug or alcohol use disorder in the past 3 months,
• • 2. History of psychotic disorder,
• • 3. History of mania or hypomania,
• • 4. Epilepsy or history of Seizure Disorder (including PNES), narcolepsy, Alzheimer Disease, Parkinson's Disease, ALS, Severe TBI, Dementia, MS, Cerebral Palsy, and Neuralgia.
• • 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. Cannot comprehend or communicate in English,
• • 11. Lack of working smartphone or lack of daily access to Internet service,
• • 12. Inability to measure skin conductance/electrodermal activity (as assessed at the screening visit), and
• • 13. Inability or unwilling to, at minimum, wear the physiological sensor (E4) wristbands, download monitoring apps, and fill out the surveys.
• • 14. Participants with more than two treatment failures (more than two adequate trials of meds on the basis of ATRQ) in the current mood episode.