Recruiting

Digital Interventions

Sponsor:

Unity Health Toronto

Code:

NCT06732089

Conditions

Major Depressive Disorder (MDD)

Major Depressive Episode

Treatment-Resistant Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Major Depressive Disorder (MDD)

Major Depressive Episode

Treatment-Resistant Major Depressive Disorder

Study ID

NCT06732089

Start date

Dec 16, 2024

Status verified date

Dec, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

rTMS

Participants in this group are enrolled to recieve rTMS treatment as part of their clinical care in the Interventional Psychiatry Program.

IVK

Participants in this group are enrolled to receive intravenous ketamine (IVK) treatment as part of their clinical care in the Interventional Psychiatry Program.

ECT

Participants in this group are enrolled to receive electroconvulsive therapy (ECT) as part of their clinical care in the Interventional Psychiatry Program.

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) ]

Central Contacts and Locations

Central contacts

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

416-360-4000venkat.bhat@unityhealth.to

Dr. Karisa Parkington, Ph.D.

416-360-4000karisa.parkington@unityhealth.to

Locations

St. Michael's Hospital, Unity Health Toronto

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

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

416-360-4000venkat.bhat@unityhealth.to

Dr. Karisa Parkington, Ph.D.

416-360-4000karisa.parkington@unityhealth.to

More Information

Sponsor

Unity Health Toronto

Last update posted

Dec 13, 2024

Last verified

Dec, 2024

Keywords

  • pilot study
  • digital health monitoring
  • wearable device
  • remote measurement-based care
  • treatment-resistant depression
  • observational study
  • feasibility study
  • electronic data capture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2024-12-13.