Sensor-based Characterization of Depression (SENSCODE)

November 2, 2023 updated by: Paola Pedrelli, Massachusetts General Hospital

Leveraging Artificial Intelligence for the Assessment of Severity of Depressive Symptoms

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Depression Clinical Research Program
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be individuals with Major Depressive Disorder

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
No Intervention
This is an observational study. There is no active treatment that is examined.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Hamilton Depression Rating Scale (HDRS) 17-items
Time Frame: 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.
Past week.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire 9 (PHQ-9)
Time Frame: 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.
Past 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Massachusetts Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019P000997

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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