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RECRUITING

NCT06773949

Feasibility Trial of Exercise as a Priming Strategy for rTMS Treatment in Difficult-to-Treat Depression

Sponsor: The Royal Ottawa Mental Health Centre

View on ClinicalTrials.gov

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.

Official title: Randomized Trial Assessing the Feasibility of Exercise as a Priming Strategy for rTMS Treatment in Difficult-to-Treat Depression

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12-15

Completion Date

2027-01-31

Last Updated

2025-12-17

Healthy Volunteers

Conditions

Major Depressive Disorder (MDD)Treatment Resistant Depression (TRD)

Interventions

DEVICE

Theta burst stimulation

Cool B70 cooled-coil (left DLPFC) with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)

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.

Locations (1)

Royal Ottawa Mental Health Centre

Ottawa, Ontario, Canada