Unipolar DepressionSENSCODENCT04370002
Sensor-based Characterization of Depression
An observational study of Unipolar Depression, run by Massachusetts General Hospital at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unipolar Depression
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jan 2020to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be individuals with Major Depressive Disorder
Who may be able to join
- Adults (ages 18-75),
- Able to read, understand, and provide written informed consent in English,
- Meet criteria for a primary psychiatric diagnosis of current major depressive disorder
- Hamilton Depression Rating Scale (HDRS) total score ≥ 18,
- Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
- Must own a working smartphone and use it regularly,
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- Must own a windows PC (or tablet) or a Mac computer (or laptop),
- Must have access to Internet service every day.
- Must have started antidepressant medications, changed medication dosage, or started therapy within 3 weeks
Who cannot join
- Active drug or alcohol use disorder in the past 3 months,
- History of psychotic disorder,
- History of mania or hypomania,
- Epilepsy or history of Seizure Disorder (including PNES), narcolepsy, Alzheimer Disease, Parkinson's Disease, ALS, Severe TBI, Dementia, MS, Cerebral Palsy, and Neuralgia.
- Untreated hypothyroidism,
- Unstable medical disease,
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- Cognitive impairment that would impede adherence to study procedures,
- Acute suicide or homicide risk,
- Current treatment with electroconvulsive therapy, vagal nerve stimulation therapy, deep brain stimulation, transcranial magnetic stimulation therapy, or phototherapy,
- Cannot comprehend or communicate in English,
- Lack of working smartphone or lack of daily access to Internet service,
- Inability to measure skin conductance/electrodermal activity (as assessed at the screening visit), and
- Inability or unwilling to, at minimum, wear the physiological sensor (E4) wristbands, download monitoring apps, and fill out the surveys.
- Participants with more than two treatment failures (more than two adequate trials of meds on the basis of ATRQ) in the current mood episode.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Depression Clinical Research Program
Boston, Massachusetts, 02114
Paola Pedrelli, Ph.D., 617-724-3678, ppedrelli@mgh.harvard.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Paola Pedrelli, Ph.D., 617-724-2936, ppedrelli@mgh.harvard.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Unipolar Depression
- Keywords
- Depression, Sensors
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | This is an observational study. There is no active treatment that is examined. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Past week.
Secondary outcomes (1)
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.
Measured: Past 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start28 Jan 2020
- Primary completion1 Sep 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Principal investigator, Paola Pedrelli, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370002
- Sponsor's protocol ID
- 2019P000997
- Acronym
- SENSCODE
- Status last verified
- Nov 2023
- First submitted
- 28 Apr 2020
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Artificial Intelligence for the Assessment of Severity of Depressive Symptoms
- ClinicalTrials.gov ID
- NCT04370002
- Acronym / sponsor ID
- SENSCODE / 2019P000997
- Conditions
- Unipolar Depression
- Keywords
- Depression, Sensors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Intervention | – | –This is an observational study. There is no active treatment that is examined. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be individuals with Major Depressive Disorder
Key inclusion criteria (9 listed)
- Adults (ages 18-75),
- Able to read, understand, and provide written informed consent in English,
- Meet criteria for a primary psychiatric diagnosis of current major depressive disorder
- Hamilton Depression Rating Scale (HDRS) total score ≥ 18,
- Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
Key exclusion criteria (14 listed)
- Active drug or alcohol use disorder in the past 3 months,
- History of psychotic disorder,
- History of mania or hypomania,
- Epilepsy or history of Seizure Disorder (including PNES), narcolepsy, Alzheimer Disease, Parkinson's Disease, ALS, Severe TBI, Dementia, MS, Cerebral Palsy, and Neuralgia.
- Untreated hypothyroidism,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Past 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unipolar Depression, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Hamilton Depression Rating Scale (HDRS) 17-items (time frame: Past week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.