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

NCT06732089 · Unity Health Toronto

Recruiting
Status
Accepting participants
Not applicable
Phase
200
Target enrolment
1
Study sites
Outside the US

What it is testing

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)) 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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Feasibility

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

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * 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) Exclusion Criteria: * 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

Where

1 study site

FacilityCityRegionCountry
St. Michael's Hospital, Unity Health TorontoTorontoOntarioCanada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06732089 on ClinicalTrials.gov →

Last updated in the registry 2024-12-13. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

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