Sensor-based Characterization of Depression

Unipolar Depression Clinical Trial

— SENSCODE  

Official title:

Leveraging Artificial Intelligence for the Assessment of Severity of Depressive Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04370002
• Other study ID #: 2019P000997
• Status: Recruiting
• Start date: January 28, 2020
• Est. completion date: November 30, 2024

Study information

• Verified date: November 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Unipolar Depression

Locations

Country	Name	City	State
United States	Depression Clinical Research Program	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Health Questionnaire 9 (PHQ-9)	The PHQ-9 is a self-report questionnaire of depressive symptoms. Total scores can vary from 0 to 27. Higher scores indicate worse depressive symptoms.	Past 7 days