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Major Depressive Disorder (MDD)NCT06732089

Digital Interventions for Adults with Treatment-Resistant Depression: a Pilot Study

An observational study of Major Depressive Disorder (MDD) and Major Depressive Episode, run by Unity Health Toronto at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to learn about remote mental health monitoring technology for adults with treatment-resistant depression. The main question it aims to answer is: are digital mental health monitoring tools (an electronic data capture platform and wearable device (e.g., smartwatch or smart-ring))… Read more about this study

Who is it for?
Ages 18 years and older
Type of treatment
Injection or infusion
How many people
200 participants
Where
1 siteCanada
Study dates
16 Dec 2024to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults suffering from treatment-resistant depression (TRD) who are being treated in the Interventional Psychiatry Program at St. Michael's Hospital, Unity Health Toronto. Patients have a confirmed diagnosis of Major Depressive Disorder (MDD) and are experiencing a Major Depressive Episode (MDE) at the time of enrollment.

Who may be able to join

  • Adults (aged 18+) who are capable of giving informed consent
  • Patients meeting diagnostic criteria for major depressive disorder (MDD) without psychotic symptoms according to the DSM-5
  • Currently experiencing a major depressive episode (MDE)
  • Montgomery-Asperg Depression Rating Scale (MADRS) score greater than 20 at screening
  • Patients meeting criteria for treatment-resistant depression (TRD): failure of 2 or more adequate trials of antidepressant therapy of adequate dose and duration during the current episode
  • Enrollment in one of the treatment modalities (rTMS, IVK, or ECT) at the Interventional Psychiatry Program at St. Michael's Hospital, Unity Health Toronto
  • Ownership of a smartphone (for participants using wearable devices)

Who cannot join

  • Individuals without Internet access (required to access study platforms)
  • Medication changes, aside from the treatment received through the IPP, one month (28 days) before screening, or during the entire duration of treatment (variable based on treatment arm)
  • Participants who do not speak English fluently enough to successfully communicate study information, answer questions accurately, and/or obtain informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dr. Venkat Bhat, M.D., F.R.C.P.C. contact

416-360-4000 ext. 76404

venkat.bhat@unityhealth.to

Dr. Karisa Parkington, Ph.D. contact

416-360-4000 ext. 76228

karisa.parkington@unityhealth.to

Canada1 site, 1 recruiting

  • St. Michael's Hospital, Unity Health Toronto

    Toronto, Ontario, M5B 1W8

    Dr. Venkat Bhat, M.D., F.R.C.P.C., 416-360-4000 ext. 76404, venkat.bhat@unityhealth.to

    Dr. Karisa Parkington, Ph.D., 416-360-4000 ext. 76228, karisa.parkington@unityhealth.to

    Recruiting

Other trials in Canada

About this study

Official title: Determining the Feasibility of Digital Interventions for Adults with Treatment-Resistant Depression

The goal of this observational study is to learn about remote mental health monitoring technology for adults with treatment-resistant depression. The main question it aims to answer is: are digital mental health monitoring tools (an electronic data capture platform and wearable device (e.g., smartwatch or smart-ring)) feasible to implement alongside clinical treatment for depression? The secondary aim of this study is to inform preliminary clinical parameters for larger, definitive studies.

Participants receiving neuropsychiatric treatment (repetitive transcranial magnetic stimulation, intravenous ketamine, or electroconvulsive therapy) as part of their regular medical care for treatment-resistant depression in the Interventional Psychiatry Program will have their clinical assessment data entered into a digital platform and will wear an accessory-based wearable device for the duration of treatment.

Read the detailed description

This observational study with retrospective data analysis is conducted in patients with treatment-resistant depression (TRD) undergoing neuropsychiatric clinical treatment (rTMS, IVK, or ECT) in the Interventional Psychiatry Program (IPP) at St. Michael's Hospital. Participants will have scores from a self-report assessment of anxiety (GAD-7) and a self-report (PHQ-9) or clinician-administered (MADRS) assessment of depression completed as part of clinical care entered into the Research Electronic Database Capture (REDCap) web-based platform after each treatment session. This will facilitate retrospective analysis of mental health symptom change and treatment response over the course of treatment. Participants will also have the opportunity to wear an accessory-based wearable device (e.g., smartwatch or ring) throughout the course of treatment to passively capture physiological biometrics of physical and mental health (e.g., heart rate, temperature, sleep, activity). This two-year pilot study aims to recruit a total of 200 participants with TRD to retrospectively assess the feasibility and efficacy of integrating remote health sensing and monitoring platforms in psychiatric clinical care.

Keywords
pilot study, digital health monitoring, wearable device, remote measurement-based care, treatment-resistant depression, observational study, feasibility study, electronic data capture
Medical subject headings
Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06732089
Study groupRoleWhat they receive
rTMSParticipants in this group are enrolled to recieve rTMS treatment as part of their clinical care in the Interventional Psychiatry Program.
IVKParticipants in this group are enrolled to receive intravenous ketamine (IVK) treatment as part of their clinical care in the Interventional Psychiatry Program.
ECTParticipants in this group are enrolled to receive electroconvulsive therapy (ECT) as part of their clinical care in the Interventional Psychiatry Program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility

    To determine the feasibility of using a web-based digital platform and wearable devices to collect active and passive data, respectively, among adults receiving clinical treatment for treatment-resistant depression. This will be measured by: number of recruitments (minimum threshold of 6-7 participants/month), recruitment rates (relative to invited patient-participants; minimum threshold of 80%), dropout rates (maximum threshold of 30%), reasons for dropout (qualitative), and data completion/adherence rates (minimum threshold of 70%).

    Measured: From Screening and Baseline Visit (Day 0) to last treatment day (approximately 2-8 weeks depending on treatment group)

Secondary outcomes (3)

  1. Longitudinal Changes in Symptom Presentation

    To quantify changes in active (clinical symptoms) and passive (physiological) measures of physical (activity) and mental health (depression, anxiety, sleep) over time. Active data will focus on anxiety and depression symptoms across treatment, as reported on the GAD-7, PHQ-9, and MADRS. Passive data will focus on physiological biometrics (e.g., heart rate, respiration, step count, metabolic equivalency, body temperature, sleep staging, skin conductance response) captured by the wearable devices.

    Measured: From Screening and Baseline Visit (Day 0) to last treatment day (approximately 2-8 weeks depending on treatment group)

  2. Predicting Treatment Response, Remission, and Relapse

    To model and predict the likelihood of a patient achieving anxiety/depression treatment response (reduction greater than or equal to 50% on clinical assessment), remission (assessment score less than clinical threshold), and relapse (assessment score greater than clinical threshold after achieving remission) captured through active self-/clinician-administered assessments, based on longitudinal active and passive data.

    Measured: From Screening and Baseline Visit (Day 0) to last treatment day (approximately 2-8 weeks depending on treatment group)

  3. Personalized Digital Phenotype Profiling (pDPP)

    To construct pDPPs (a.k.a. digital fingerprints) for each participant based on longitudinal active and passive data. This will be achieved using machine learning (ML), artificial intelligence (AI), and advanced data analytic principles.

    Measured: From Screening and Baseline Visit (Day 0) to last treatment day (approximately 2-8 weeks depending on treatment group)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2024
  2. Study start16 Dec 2024 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Case only
Time perspective
Retrospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06732089
Sponsor's protocol ID
21-274
Other IDs
Miner's Lamp Foundation
Status last verified
Dec 2024
First submitted
9 Dec 2024
Last updated
13 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Parkington K, Aguilar RJ, Lee GH, Rueda A, Adamsahib F, Al-Hassan M, Famuditimi S, Menzies P, Lin Q, Lou W, Krishnan S, Bhat V. Digital health monitoring for adults with treatment-resistant depression: Observational feasibility study protocol. PLoS One. 2025 Oct 24;20(10):e0333484. doi: 10.1371/journal.pone.0333484. eCollection 2025.

    PubMed 41134764

Questions about this trial

What is this clinical trial studying?

An observational study of Major Depressive Disorder (MDD) and Major Depressive Episode, run by Unity Health Toronto at 1 site in Canada.

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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Dec 2024. 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 Canada. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr. Venkat Bhat, M.D., F.R.C.P.C. (416-360-4000 ext. 76404, venkat.bhat@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (time frame: From Screening and Baseline Visit (Day 0) to last treatment day (approximately 2-8 weeks depending on treatment group)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06732089, which also lists 1 linked publication.

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 13 Dec 2024.

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