Digital health tools for adults with treatment-resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the feasibility of using digital mental health monitoring tools, including an electronic data capture platform and wearable devices, for adults suffering from treatment-resistant depression. Participants undergoing neuropsychiatric treatments such as repetitive transcranial magnetic stimulation, intravenous ketamine, or electroconvulsive therapy will have their clinical assessment data recorded and analyzed. The study will also assess physiological data collected from wearable devices to understand changes in mental health symptoms and treatment responses over time. The goal is to inform future larger studies on the integration of remote health monitoring in psychiatric care.

Why it matters

Who can join: the full rules

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 it's running

• St. Michael's Hospital, Unity Health Toronto
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Dr. Venkat Bhat, M.D., F.R.C.P.C.
• Email: venkat.bhat@unityhealth.to
• Phone: 416-360-4000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• ALKS 7290 added to antidepressants for adults with major depression

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  Recruiting Phase 2 Alkermes, Inc. · Jacksonville, Florida · NCT07901179

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.