Life sciences · Interventional Study
ClinicalTrials.gov · September 29, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06773949). This is a study registration, not published results. Lead sponsor: The Royal Ottawa Mental Health Centre. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 20 participants (ESTIMATED). Conditions: Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD). Interventions: DEVICE: Theta burst stimulation. Primary outcome measures: Assessing feasibility on combining structured exercise and intermittent Theta Burst Stimulation (iTBS) in participants with treatment-resistant depression (TRD) , Assessed at the end of the study once all participants have completed the study.; Compare the effects on clinical response of exercise on enhancing iTBS treatment efficacy vs. iTBS alone , Administered at screening, before iTBS treatment course (week 4), at the end of the treatment course (week 10), then at the 6-week follow-up (week 16). 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.