NCT06773949 Feasibility Trial of Exercise as a Priming Strategy for rTMS Treatment in Difficult-to-Treat Depression
| NCT ID | NCT06773949 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Royal Ottawa Mental Health Centre |
| Condition | Major Depressive Disorder (MDD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-12-15 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Are between 18-75 years old. 2. Able to provide voluntary informed consent. 3. Diagnosis of MDD or Persistent Depressive Disorder, without psychotic features, confirmed by MINI for DSM-5. 4. Depressive symptoms have not improved after ≥ 1 adequate antidepressant trial in the current episode (i.e., difficult-to-treat MDD), based on the Antidepressant Treatment History Form (ATHF). 5. Baseline score of ≥15 on the HRSD-17. 6. No change in psychotropic medications or psychotherapy regimen at least 4 weeks prior to entering the trial 7. Physically inactive as per the International Physical Activity Questionnaire - Short Form (IPAQ-SF). 8. Able to engage in structured exercise as per the Get Active Questionnaire (GAQ). 9. Able to adhere to the proposed treatment schedule. Exclusion Criteria: 1. Diagnosis of bipolar I or II disorder, based on DSM-5 criteria. 2. Current or past (\<3 months) substance (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in DSM-5 criteria. 3. Current use of illegal substances. 4. Current use of cannabis. 5. Concomitant major unstable medical or neurologic illness (e.g., uncontrolled diabetes or renal dysfunction). 6. Organic cause of the depressive symptoms (e.g. thyroid dysfunctions), determined by the referring physician. 7. Acute suicidality or threat to life from self-neglect. 8. Pregnant or breastfeeding, or thinking of becoming pregnant during course of treatment. 9. Contraindication for TMS and MRI (e.g., personal history of epilepsy or seizure, metallic head implant, pacemaker), confirmed by TMS Adult Safety Scale (TASS) and MRI pre-screener. 10. Unwilling to maintain current psychotropic medication and/or psychotherapy regimen for the four weeks prior to and for the duration of the study. 11. Taking more than 1 mg/day of lorazepam or equivalent. 12. Any other condition that, in the opinion of the investigators which would adversely affect the participant's ability to complete the study. 13. Physically active: performing exercise and/or physical activity levels meeting the cut-off for "minimally active" on the IPAQ-SF.
Contact & Investigator
Sara Tremblay, PhD
PRINCIPAL INVESTIGATOR
Royal Ottawa Mental Health Centre
Frequently Asked Questions
Who can join the NCT06773949 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Major Depressive Disorder (MDD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06773949 currently recruiting?
Yes, NCT06773949 is actively recruiting participants. Contact the research team at stacey.shim@theroyal.ca for enrollment information.
Where is the NCT06773949 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT06773949 clinical trial?
NCT06773949 is sponsored by The Royal Ottawa Mental Health Centre. The principal investigator is Sara Tremblay, PhD at Royal Ottawa Mental Health Centre. The trial plans to enroll 20 participants.