DepressionNCT02568865
Noninvasive Physiologic Sensors to Assess Depression
An observational study of Depression and Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This project aims to use sensors to monitor physiological signals, sleep patterns, vocal characteristics, activity, location and phone usage in study patients with depression who are receiving standard treatment (compared with healthy controls). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Major Depressive Disorder
- What is being tested?
- Physiological Sensors, Sleep Monitoring Device and Vocal Monitoring
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2016to 3 Jan 2020
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult outpatients with a current major depressive episode (n=40) and healthy adult controls (n=10).
Who may be able to join
- Patients with Depression (n=40):
- Adults (ages 18-75),
- Able to read, understand, and provide written informed consent in English,
- Meet criteria for a primary psychiatric diagnosis of major depressive disorder for ≥ 4 weeks, according to the M.I.N.I (Mini International Neuropsychiatric Interview),
- Hamilton Depression Rating Scale (HDRS) total score ≥ 18,
- Engaged in or willing to be referred for clinical care for depression treatment as usual (antidepressants and/or psychotherapy),
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- Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
- Must own a working Android smartphone (Android 2.3+) and use it regularly,
- Must own a windows PC (or tablet) or a Mac computer (or laptop),
- Must have access to Internet service every day.
- Healthy Controls (n=10):
- Adults (ages 18-75),
- Able to read, understand, and provide written informed consent in English,
- Not meet criteria for past or current psychiatric illness, excluding specific phobias, as measured by the M.I.N.I.,
- Not have a first-degree relative with known major psychiatric illness including Major Depressive Disorder, Bipolar Disorder, Psychotic Disorder or Substance Use Disorder,
- Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
- Must own a working Android smartphone (Android 2.3+) and use it regularly,
- Must own a windows PC (or tablet) or a Mac computer (or laptop),
- Must have access to Internet service every day.
Who cannot join
- Active drug or alcohol use disorder in the past 3 months,
- History of psychosis,
- History of mania or hypomania,
- Epilepsy or history of seizures,
- 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,
- Concurrent participation in other research studies,
- 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) bands, fill out the surveys, and record a weekly diary.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Non-Invasive Physiologic Sensors to Assess Depression
This project aims to use sensors to monitor physiological signals, sleep patterns, vocal characteristics, activity, location and phone usage in study patients with depression who are receiving standard treatment (compared with healthy controls).
- Conditions
- Depression, Major Depressive Disorder
- Being tested
- Physiological Sensors, Sleep Monitoring Device, Vocal Monitoring, Mobile Phone
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological SensorsOther
Wearable biosensors can play an important role in depression diagnosis. For this study, we will use a cost-effective, unobtrusive, and non-stigmatizing sensor to monitor physiological signals (including heart rate (HR), heart rate variability (HRV), electrodermal activity (EDA), physical activity, and temperature).
Sleep Monitoring DeviceOther
The X4 Device is an internally battery powered FDA-classified Type BF device used for configurable acquisition of physiological signals via EEG.
Vocal MonitoringOther
The participants will be provided with a phone app to leave audio diary recordings.
Mobile PhoneOther
A mobile phone and tablet will be used for various purposes, including, recording of socialization, location, and activity patterns of participants and to collect emotional information based on interactive surveys, as well as for forwarding sleep and physiological sensor measurements to a secure server.
| Study group | Role | What they receive |
|---|---|---|
| Major Depressive Disorder | Not described Receives: Other: Physiological Sensors; Other: Sleep Monitoring Device; Other: Vocal Monitoring; Other: Mobile Phone | |
| Healthy Volunteers | Not described Receives: Other: Physiological Sensors; Other: Sleep Monitoring Device; Other: Vocal Monitoring; Other: Mobile Phone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologic Biorhythms (heart rate)
We will measure the heart rate at baseline and during the treatment period. We will compare the corresponding patterns in patients with depression, as well as in healthy controls.
Measured: 8 weeks
Phone Usage
We will measure the cell-phone usage (in the form of texts, web browsing, and phone calls) at the beginning of the study and during the treatment period. We will compare the corresponding phone usage patterns in patients with depression, as well as in healthy controls.
Measured: 8 weeks
Voice Characteristics
We will measure the voice characteristics (via reading a 30-second script as part of an audio diary) at the beginning of the study and during the treatment period. We will compare the corresponding voice characteristics in patients with depression, as well as in healthy controls.
Measured: 8 weeks
Physiologic Biorhythms (Skin conductance)
We will measure the skin conductance at baseline and during the treatment period. We will compare the corresponding patterns in patients with depression, as well as in healthy controls.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study start15 Jan 2016
- Primary completion1 Jul 2018
- Study completion3 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Mischoulon, MD, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568865
- Sponsor's protocol ID
- 2015P001913
- Status last verified
- Feb 2020
- First submitted
- 14 Sep 2015
- Last updated
- 25 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Physiologic Sensors to Assess Depression
- ClinicalTrials.gov ID
- NCT02568865
- Acronym / sponsor ID
- 2015P001913
- Conditions
- Depression, Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 6 Oct 2015 (estimated)
- 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 project aims to use sensors to monitor physiological signals, sleep patterns, vocal characteristics, activity, location and phone usage in study patients with depression who are receiving standard treatment (compared with healthy controls).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder | – | Other: Physiological Sensors, Other: Sleep Monitoring Device, Other: Vocal Monitoring, Other: Mobile Phone |
| Healthy Volunteers | – | Other: Physiological Sensors, Other: Sleep Monitoring Device, Other: Vocal Monitoring, Other: Mobile Phone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult outpatients with a current major depressive episode (n=40) and healthy adult controls (n=10).
Key inclusion criteria (19 listed)
- Adults (ages 18-75),
- Able to read, understand, and provide written informed consent in English,
- Meet criteria for a primary psychiatric diagnosis of major depressive disorder for ≥ 4 weeks, according to the M.I.N.I (Mini International Neuropsychiatric Interview),
- Hamilton Depression Rating Scale (HDRS) total score ≥ 18,
- Engaged in or willing to be referred for clinical care for depression treatment as usual (antidepressants and/or psychotherapy),
Key exclusion criteria (14 listed)
- Active drug or alcohol use disorder in the past 3 months,
- History of psychosis,
- History of mania or hypomania,
- Epilepsy or history of seizures,
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiological SensorsWearable biosensors can play an important role in depression diagnosis. For this study, we will use a cost-effective, unobtrusive, and non-stigmatizing sensor to monitor physiological signals (including heart rate (HR), heart rate variability (HRV), electrodermal activity (EDA), physical activity, and temperature). | Other | Healthy Volunteers, Major Depressive Disorder |
| Sleep Monitoring DeviceThe X4 Device is an internally battery powered FDA-classified Type BF device used for configurable acquisition of physiological signals via EEG. | Other | Healthy Volunteers, Major Depressive Disorder |
| Vocal MonitoringThe participants will be provided with a phone app to leave audio diary recordings. | Other | Healthy Volunteers, Major Depressive Disorder |
| Mobile PhoneA mobile phone and tablet will be used for various purposes, including, recording of socialization, location, and activity patterns of participants and to collect emotional information based on interactive surveys, as well as for forwarding sleep and physiological sensor measurements to a secure server. | Other | Healthy Volunteers, Major Depressive Disorder |
Primary outcome
Physiologic Biorhythms (heart rate)
Time frame: 8 weeks
We will measure the heart rate at baseline and during the treatment period. We will compare the corresponding patterns in patients with depression, as well as in healthy controls.
Phone Usage
Time frame: 8 weeks
We will measure the cell-phone usage (in the form of texts, web browsing, and phone calls) at the beginning of the study and during the treatment period. We will compare the corresponding phone usage patterns in patients with depression, as well as in healthy controls.
Voice Characteristics
Time frame: 8 weeks
We will measure the voice characteristics (via reading a 30-second script as part of an audio diary) at the beginning of the study and during the treatment period. We will compare the corresponding voice characteristics in patients with depression, as well as in healthy controls.
Physiologic Biorhythms (Skin conductance)
Time frame: 8 weeks
We will measure the skin conductance at baseline and during the treatment period. We will compare the corresponding patterns in patients with depression, as well as in healthy controls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Major Depressive Disorder, run by Massachusetts General Hospital at 1 site 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 19 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: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiologic Biorhythms (heart rate) (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 25 Feb 2020; AzTrials last refreshed its copy on 3 Nov 2026.