NCT06773949Recruiting
Feasibility Trial of Exercise as a Priming Strategy for rTMS Treatment in Difficult-to-Treat Depression
Randomized Trial Assessing the Feasibility of Exercise as a Priming Strategy for rTMS Treatment in Difficult-to-Treat Depression
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 8 Jan 2025
- Start date
- 1 Mar 2026
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Diseases
- Depression
- NCT number
- NCT06773949
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Mar 2026 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant major unstable medical or neurologic illness (e.g., uncontrolled diabetes or renal dysfunction).
- Unwilling to maintain current psychotropic medication and/or psychotherapy regimen for the four weeks prior to and for the duration of the study.
Other illness
- Diagnosis of bipolar I or II disorder, based on DSM-5 criteria.
- 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.
- Any other condition that, in the opinion of the investigators which would adversely affect the participant's ability to complete the study.
Other
- Current or past (\<3 months) substance (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in DSM-5 criteria.
- Current use of illegal substances.
- Current use of cannabis.
- Organic cause of the depressive symptoms (e.g. thyroid dysfunctions), determined by the referring physician.
- Acute suicidality or threat to life from self-neglect.
- Pregnant or breastfeeding, or thinking of becoming pregnant during course of treatment.
- Taking more than 1 mg/day of lorazepam or equivalent.
- Physically active: performing exercise and/or physical activity levels meeting the cut-off for "minimally active" on the IPAQ-SF.
Who the study is looking for
- Are between 18-75 years old.
- Able to provide voluntary informed consent.
- Diagnosis of MDD or Persistent Depressive Disorder, without psychotic features, confirmed by MINI for DSM-5.
- 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).
- Baseline score of ≥15 on the HRSD-17.
- No change in psychotropic medications or psychotherapy regimen at least 4 weeks prior to entering the trial
- Physically inactive as per the International Physical Activity Questionnaire - Short Form (IPAQ-SF).
- Able to engage in structured exercise as per the Get Active Questionnaire (GAQ).
- Able to adhere to the proposed treatment schedule.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Ottawa Mental Health Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.