Actively Recruiting
Feasibility Trial of Exercise as a Priming Strategy for rTMS Treatment in Difficult-to-Treat Depression
Led by The Royal Ottawa Mental Health Centre · Updated on 2025-12-17
20
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
Sponsors
T
The Royal Ottawa Mental Health Centre
Lead Sponsor
U
University of Ottawa
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study is to collect feasibility data on combining structured exercise aimed to improve physical fitness, and intermittent TBS (iTBS) in treating individuals diagnosed with difficult-to-treat depression who are physically inactive. By conducting this trial, we will compare the therapeutic benefits of the combined approach against the standard treatment of iTBS alone (without exercise). These findings will be used to inform future large-scale projects in which we will investigate, in a larger sample size, whether structured exercise aimed to improve fitness as recommended by most public exercise guidelines (i.e., ≥3x/week, moderate-to-vigorous intensity) serves as an active ingredient that amplifies the effectiveness of iTBS. Ultimately, the insights gained from this study will be valuable for clinicians seeking to alleviate depressive symptoms in MDD through neuromodulation techniques such as iTBS.
CONDITIONS
Official Title
Feasibility Trial of Exercise as a Priming Strategy for rTMS Treatment in Difficult-to-Treat Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 75 years old
- Able to provide voluntary informed consent
- Diagnosis of Major Depressive Disorder or Persistent Depressive Disorder without psychotic features confirmed by MINI for DSM-5
- Depressive symptoms unresponsive to at least one adequate antidepressant trial in the current episode
- Baseline depression score of 15 or higher on the HRSD-17
- No changes in psychotropic medications or psychotherapy for at least 4 weeks before the study
- Physically inactive according to the International Physical Activity Questionnaire - Short Form
- Able to participate in structured exercise as assessed by the Get Active Questionnaire
- Able to follow the treatment schedule
You will not qualify if you...
- Diagnosis of bipolar I or II disorder
- Current or recent (within 3 months) substance or alcohol abuse/dependence (excluding caffeine or nicotine)
- Current use of illegal substances or cannabis
- Major unstable medical or neurological illness (e.g., uncontrolled diabetes or kidney problems)
- Depressive symptoms caused by organic conditions (e.g., thyroid issues)
- Acute suicidality or life-threatening self-neglect
- Pregnant, breastfeeding, or planning pregnancy during treatment
- Contraindications for TMS or MRI (e.g., epilepsy, metallic implants, pacemaker)
- Unwilling to maintain current medication or therapy regimen for the study duration
- Taking more than 1 mg/day of lorazepam or equivalent
- Any condition that may interfere with study completion as judged by investigators
- Physically active at or above the "minimally active" level on the physical activity questionnaire
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Royal Ottawa Mental Health Centre
Ottawa, Ontario, Canada, k1z 7k4
Actively Recruiting
Research Team
S
Stacey Shim, MSc
CONTACT
E
Emma Cummings, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here