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SENSCODE: Sensor-based Characterization of Depression

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04370002
Collaborator
Massachusetts Institute of Technology (Other)
100
Enrollment
2
Locations
45.1
Anticipated Duration (Months)
50
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Leveraging Artificial Intelligence for the Assessment of Severity of Depressive Symptoms
    Actual Study Start Date :
    Jan 28, 2020
    Anticipated Primary Completion Date :
    Jul 1, 2023
    Anticipated Study Completion Date :
    Oct 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    No Intervention

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

    Outcome Measures

    Primary Outcome Measures

    1. The Hamilton Depression Rating Scale (HDRS) 17-items [Past week.]

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

    Secondary Outcome Measures

    1. Patient Health Questionnaire 9 (PHQ-9) [Past 7 days]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Depression Clinical Research Program Boston Massachusetts United States 02114
    2 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • Massachusetts Institute of Technology

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paola Pedrelli, Assistant Professor, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT04370002
    Other Study ID Numbers:
    • 2019P000997
    First Posted:
    Apr 30, 2020
    Last Update Posted:
    Oct 14, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Paola Pedrelli, Assistant Professor, Massachusetts General Hospital
    Depression
    Sensors
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder

    Study Results

    No Results Posted as of Oct 14, 2021