Exercise + TBS for Depression

Recruiting in Palo Alto (17 mi)

Overseen BySara Tremblay, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The Royal Ottawa Mental Health Centre

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for individuals with difficult-to-treat depression who are physically inactive. It aims to see if adding structured exercise to a treatment called intermittent Theta Burst Stimulation (iTBS) can help more than iTBS alone.

Inclusion Criteria

Able to provide voluntary informed consent

I am between 18 and 75 years old.

I have been diagnosed with major depression or persistent depressive disorder, without psychosis.

+6 more

Exclusion Criteria

Current or past (<3 months) substance (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in DSM-5 criteria

Current use of cannabis

Acute suicidality or threat to life from self-neglect

+10 more

Participant Groups

The study tests whether combining regular, moderate-to-vigorous exercise with iTBS is more effective in treating major depressive disorder than just iTBS on its own. Participants will be compared to see the difference in therapeutic benefits.

2Treatment groups

Experimental Treatment

Group I: Standard GroupExperimental Treatment1 Intervention

Standard care of 4 weeks of stable treatment (i.e. no changes to antidepressant regimen or physical activity) followed by 6 weeks of iTBS alone.

Group II: Intervention GroupExperimental Treatment1 Intervention

4-weeks of exercise (moderate-to-vigorous intensity) followed by 6 weeks of iTBS combined with exercise.