NCT06732089Recruiting
Digital Interventions for Adults with Treatment-Resistant Depression: a Pilot Study
Determining the Feasibility of Digital Interventions for Adults with Treatment-Resistant Depression
Source: ClinicalTrials.gov · Last updated 13 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 9 Dec 2024
- Start date
- Dec 2024
- Primary completion date
- Oct 2026
- Lead sponsor
- Unity Health Toronto
- Diseases
- Depression
- NCT number
- NCT06732089
What you commit to
- Study type: Observational
- Planned participants: 200
- From Dec 2024 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other
- Individuals without Internet access (required to access study platforms)
- Participants who do not speak English fluently enough to successfully communicate study information, answer questions accurately, and/or obtain informed consent
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Michael's Hospital, Unity Health Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.