Comparing Uni- and Bi-lateral TBS in Major Depression
ConditionMajor Depressive Episode
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Royal Ottawa Mental Health Centre
About this trial
Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS) is a very promising new treatment for major depression that allows a 15-fold reduction in duration of daily sessions. However, no large scale naturalistic study has assessed the superiority of bilateral TBS in comparison with unilateral left TBS. In fact, no TBS study thus far has included both unipolar and bipolar depression, or other psychiatric comorbidities such as anxiety. Maintenance has yet to be studied with TBS, along with an effective maintenance protocol to prevent relapse. Our study aims to explore and address these gaps.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 in the current depressive episode (confirmed by a Mini-International Neuropsychiatric Interview),
Disqualifiers
current or past (< 3 months) substance (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in the Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria. Based on the DSM-5 criteria, mild cannabis or alcohol use would be permissible in the past 3 months, moderate to severe would be an exclusion
current use of illegal substances or recreational cannabis
have a concomitant major unstable medical or neurologic illness (e.g. uncontrolled diabetes or renal dysfunction),
organic cause to the depressive symptoms (e.g. thyroid dysfunctions), determined by the referring physician
Trial design
Design model
Parallel
Treatments tested in this trial
Theta burst stimulation
DeviceCool B70 coil (left DLPFC) and Cool B65 active/placebo coil (right DLPFC), with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)
Treatment groups
256 Participants
are divided into 3 treatment groupsGroup A: Unilateral TBSActive comparator 1 intervention
Group B: Bilateral TBSActive comparator 1 intervention
Group C: Maintenance Phase: FlexibleActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Response - Treatment Phase (Hamilton Rating Scale for Depression-17 score)
Response to treatment will be defined as a \> 50% reduction in pre-treatment symptoms severity as measured by the mean Hamilton Rating Scale for Depression-17 score. The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome.
Time frame
Week 62
Remission - Treatment Phase (Hamilton Rating Scale for Depression-17 Score)
Remission will be defined as a Hamilton Rating Scale for Depression-17 score ≤ 8 The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome.
Time frame
End of treatment phase (week 4 or 6)3
Response - Maintenance Phase (Hamilton Rating Scale for Depression-17 score)
Response to treatment will be defined as a \> 50% reduction in pre-treatment symptoms severity as measured by the mean Hamilton Rating Scale for Depression-17 score. The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome
Time frame
6 months4
Remission - Maintenance Phase (Hamilton Rating Scale for Depression-17 Score)
Remission will be defined as a Hamilton Rating Scale for Depression-17 score ≤ 8 The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome.
Time frame
6 monthsSecondary outcomes
1
Response - Treatment Phase (Quick Inventory of Depression Symptomology-Self Report)
Response to treatment will be defined as a \> 50% reduction in pre-treatment symptoms severity as measured by the mean the Quick Inventory of Depression Symptomology-Self Report score. The minimum value is 0 and the maximum value is 48. A higher score indicates a negative outcome.
Time frame
Week 62
Remission - Treatment Phase (Quick Inventory of Depression Symptomology-Self Report)
Remission will be defined as a Quick Inventory of Depression Symptomology-Self Report score ≤ 6. The minimum value is 0 and the maximum value is 48. A higher score indicates a negative outcome
Time frame
End of treatment phase (week 4 or 6)3
Response - Maintenance Phase (Quick Inventory of Depression Symptomology-Self Report)
Response to treatment will be defined as a \> 50% reduction in pre-treatment symptoms severity as measured by the mean the Quick Inventory of Depression Symptomology-Self Report score. The minimum value is 0 and the maximum value is 48. A higher score indicates a negative outcome.
Time frame
6 months4
Remission - Maintenance Phase Quick Inventory of Depression Symptomology-Self Report)
Remission will be defined as a Quick Inventory of Depression Symptomology-Self Report score ≤ 6. The minimum value is 0 and the maximum value is 48. A higher score indicates a negative outcome.
Time frame
6 monthsOther outcomes
1
Cortical Activity - Treatment Phase
TMS-EEG measure of cortical activity (change in pre-treatment TMS-evoked potential amplitude in µV).
Time frame
Week 62
Cortical Activity - Maintenance Phase
TMS-EEG measure of cortical activity (change in pre-treatment TMS-evoked potential amplitude in µV).
Time frame
6 months3
Resting State Connectivity
Investigate if baseline levels of GABA/Glutamate in the anterior cingulate cortex (ACC) and baseline levels of resting state connectivity between the left dorsolateral prefrontal. cortex (DLPFC) and ACC are linked to therapeutic response, using resting state functional Connectivity between target sites and anterior cingulate cortex (ACC)
Time frame
6 months4
Magnetic Resonance Spectroscopy
Baseline levels of gamma-aminobutyric acid (GABA) and Glutamate in the anterior cingulate cortex (ACC)
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov