Actively Recruiting
Randomized Trial Assessing Feasibility 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
N/A
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
Researchers are investigating whether combining structured exercise with intermittent Theta Burst Stimulation (iTBS) can improve treatment outcomes for individuals with difficult-to-treat depression who are physically inactive. This pilot trial aims to collect feasibility data comparing this combined approach against standard iTBS treatment alone. The study focuses on treatment-resistant depression and seeks to understand if exercise enhances the brain's response to neuromodulation therapies like iTBS. Participants will be randomly assigned to one of two groups. The intervention group will first engage in 4 weeks of moderate-to-vigorous exercise sessions lasting about one hour, three times per week, followed by 6 weeks of combined iTBS treatment and exercise. The control group will have 4 weeks of stable treatment without changes in medication or activity, followed by 6 weeks of iTBS alone. In both groups, iTBS will be administered five times per week with each session lasting approximately 3 minutes. During the study, participants will undergo assessments at multiple time points including before and after iTBS treatment and at a 6-week follow-up. These assessments include self-reported measures of depression, anxiety, suicidal thoughts, and hopelessness, as well as brain imaging, neurophysiology tests, grip strength, and physical measurements. The study will evaluate how feasible it is to deliver the combined treatment and will monitor adherence, symptom changes, and neuroplasticity effects over the course of the trial, which lasts approximately 10 weeks plus follow-up.
CONDITIONS
Brief 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
- Diagnosed with Major Depressive Disorder or Persistent Depressive Disorder without psychotic features
- Depressive symptoms have not improved after at least one adequate antidepressant trial in the current episode
- Baseline score of 15 or higher on the HRSD-17
- No change in psychotropic medications or psychotherapy for at least 4 weeks before the trial
- Physically inactive according to the International Physical Activity Questionnaire - Short Form
- Able to engage in structured exercise as per the Get Active Questionnaire
- Able to follow the proposed treatment schedule
You will not qualify if you...
- Diagnosis of bipolar I or II disorder
- Current or past substance or alcohol abuse/dependence within the last 3 months (excluding caffeine or nicotine)
- Current use of illegal substances
- Current use of cannabis
- Major unstable medical or neurological illness
- Organic cause of depressive symptoms (e.g., thyroid dysfunction)
- 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 and psychotherapy regimen for trial duration
- Taking more than 1 mg/day of lorazepam or equivalent
- Any other condition that may affect ability to complete the study
- Physically active meeting minimally active criteria on the IPAQ-SF
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants in the intervention group engage in 4 weeks of moderate-to-vigorous intensity exercise sessions lasting about 1 hour, 3 times per week to improve brain plasticity before starting iTBS treatment. Participants in the control group maintain stable treatment with no changes to medication or physical activity.
Exercise sessions 3 times per week (intervention group)
Duration - 6 weeks
Participants receive 6 weeks of intermittent Theta Burst Stimulation (iTBS). The intervention group continues exercise combined with iTBS, while the control group receives iTBS alone.
iTBS treatment 5 times per week; exercise sessions 3 times per week (intervention group)
Duration - 6 weeks
Participants are assessed 6 weeks after the end of treatment to monitor clinical response and other outcomes.
1 visit (in-person) at week 16
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
E
Emma Cummings, BSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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