Comparing Uni- and Bi-lateral TBS in Major Depression
Major Depressive Episode
About this trial
This is an interventional treatment trial for Major Depressive Episode
Eligibility Criteria
Inclusion Criteria:
- voluntary and competent to consent to study,
- female or male aged 18 years old or older,
- can speak and read English and/or French
- primary and/or predominant diagnosis of major depressive episode without psychotic features (confirmed by a Mini-International Neuropsychiatric Interview),
- depressive symptoms have not improved after ≥ 1 but ≤ 7 adequate dose of antidepressant trial in the current depressive episode,
- moderate symptoms in the current depressive episode as indexed by a score of at least 15 at the 17-item Hamilton Rating Scale for Depression (HRSD-17),
- have been referred to rTMS treatment by their treating physician, and took a free and informed decision to follow this treatment,
- are able to adhere to treatment schedule,
- have received a stable medication (including prescribed cannabis) or psychotherapy regiment for at least four weeks prior to entering the trial,
- have an education-adjusted score of ≥ 24 at the Mini-Mental State Evaluation (MMSE) if are aged ≥ 65.
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 illegal substances or recreational cannabis
- have a concomitant major unstable medical or neurologic illness (e.g. uncontrolled diabetes or renal dysfunction),
- significant laboratory test abnormalities (e.g. thyroid dysfunctions),
- acute suicidality or threat to life from self-neglect,
- are pregnant or breastfeeding, or thinking of becoming pregnant during course of treatment,
- have a specific contraindication for TMS (e.g., personal history of epilepsy or seizure, metallic head implant, pacemaker),
- unwilling to maintain current antidepressant regiment,
- are taking more than 1 mg of lorazepam or equivalent,
- any other condition that, in the opinion of the investigators, would adversely affect the participant's ability to complete the study,
- have failed a course of ECT within the current depressive episode due to the lower likelihood of response to rTMS.
Sites / Locations
- The Royal Ottawa Mental Health CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Unilateral TBS
Bilateral TBS
Maintenance Phase: Flexible
Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC. Realistic sham continuous TBS (cTBS-sham) will be applied to the right DLPFC. Participants will receive daily sessions (Mon-Fri) for 4 to 6 weeks (stop at 4 weeks if remission is achieved).
Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC and continuous TBS (cTBS) will be applied to the right DLPFC. Participants will receive daily sessions (Mon-Fri) for 4 to 6 weeks (stop at 4 weeks if remission is achieved).
The flexible maintenance protocol will be based on symptom emergence. Participants will receive a fixed TBS (2x/week) schedule for the first month. For the following months (2-6), they will come in for an assessment (HRSD-17) to determine how many TBS sessions (0, 1, or 2) they receive on a flexible basis.