Image

Sensor-based Characterization of Depression

Sensor-based Characterization of Depression

Recruiting
18-75 years
All
Phase N/A

Powered by AI

Overview

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.

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 derived by wearable devices and socialization and activity data derived by mobile applications. The study will utilize advanced statistical methods to integrate different sources of passive sensor-based behavioral and physiological data to develop models able to detect depression and predict treatment response.

Eligibility

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.

Study details
    Unipolar Depression

NCT04370002

Massachusetts General Hospital

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.