Major Depressive Disorder (MDD)Major Depressive EpisodeTreatment-Resistant Major Depressive Disorder
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Feasibility — From Screening and Baseline Visit (Day 0) to last treatment day (approximately 2-8 weeks depending on treatment group) 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%).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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