Feasibility Trial of Exercise as a Priming Strategy for rTMS Treatment in Difficult-to-Treat Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Royal Ottawa Mental Health Centre
About 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 does not accept healthy volunteersQualifiers
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).
Disqualifiers
Diagnosis of bipolar I or II disorder, based on DSM-5 criteria.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Theta burst stimulation
DeviceCool B70 cooled-coil (left DLPFC) with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Standard GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
Assessing feasibility on combining structured exercise and intermittent Theta Burst Stimulation (iTBS) in participants with treatment-resistant depression (TRD)
Feasibility outcomes are crucial metrics that will guide the refinement of our protocols, thereby enhancing our preparedness for future design endeavors. These will include: 1) recruitment, 2) adherence, 3) compliance, 4) retention, 5) satisfaction, and 6) adverse events.
Time frame
Assessed at the end of the study once all participants have completed the study.2
Compare the effects on clinical response of exercise on enhancing iTBS treatment efficacy vs. iTBS alone
Clinical response will be defined as a ≥ 50% reduction in the 17-item Grid Hamilton Rating Scale for Depression (Grid-HRSD-17). The Grid HRSD is a clinician-rated instrument with seventeen items used to measure the severity of depressive episodes. The overall score ranges from 0 to 52, where scores of 0 to 7 are considered as being normal, 8 to 16 suggest mild depression, 17 to 23 moderate depression, and scores ≥ 24 indicate severe depression.
Time frame
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)Secondary outcomes
1
Change in self-reported depression symptoms as measured by Beck Depression Inventory (BDI-II).
As a secondary measure of depressive symptoms. Score scale from 0 (better outcome, no depression) to 63 (worst outcome, extreme depression).
Time frame
Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)2
Change in self-reported anxiety symptoms as measured by Beck Anxiety Inventory (BAI)
As a secondary measure of anxiety symptoms. Score scale from 0 (better outcome, no depression) to 63 (worst outcome, extreme anxiety).
Time frame
Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)3
Change in self-reported suicidal thoughts symptoms as measured by Beck Scale for Suicidal Ideation (BSS)
To assess the effect of treatment on suicidal thoughts that may be improved by iTBS. Score scale from 0 (better outcome, no desire for suicide) to 38 (worst outcome, extreme desire for suicide).
Time frame
Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)4
Change in self-reported hopelessness as measured by State Hope Scale (SHS)
To assess the effect of treatment on self-report symptoms and perceptions of stress that may be improved by iTBS. 6-item measure where responses are rated on an 8-point Likert scale. Score scale from 1 (Definitely True) to 8 (Definitely False).
Time frame
Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)Other outcomes
1
Incidence of Treatment-Emergent Adverse Events
Adverse events will be tracked and recorded.
Time frame
Daily Monday-Friday throughout study (16 weeks).2
Side Effects
Side effects will be tracked and recorded on any TMS visits, using the TMS side effects questionnaire.
Time frame
Daily Monday-Friday throughout study (16 weeks).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Royal Ottawa Mental Health Centre
Lead sponsor
University of Ottawa
Collaborator
Source ClinicalTrials.gov