Repetitive Transcranial Magnetic Stimulation (rTMS) using intermittent theta burst stimulation (iTBS) has been found to be a non inferior protocol to standard rTMS for the treatment of major depressive disorder. An accelerated course is of particular interest given the safety profile of the procedure and the potential to treat people more quickly making the treatment more accessible. This study aims to assess the feasibility and clinical outcomes of a high dose iTBS protocol in patients with depression in the context of unipolar or bipolar II disorder who are waiting for Electroconvulsive therapy (ECT) or rTMS due to degree of treatment resistance or severity of symptoms. This is a prospective, open-label, interventional pilot study wherein patients who have been diagnosed with major depressive disorder and referred to brain stimulation clinic, will be recruited for the treatment. Patients will be administered eight questionnaires before and after the treatment to assess the change in clinical outcomes.
Participants will receive same stimulation protocol, however they will be given 6 times per day instead of once per day. Each Treatment will consist of a single iTBS treatment delivering 600 puses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duy cycle of 2 seconds on, 8 seconds off, over 60 cycles and it takes about 3 minutes at a target of 90 to 120% of the subject's resting motor threshold. Treatment will be given through the device that is usually used, which is Magpro by Magventure, B70 Fluid-Cooled Coil .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
The intervention is used regularly for patients with treatment resistant depression, however, in this trial it will be given multiple times per day and over less days than the usual protocol
Robyn
Whitby, Ontario, Canada
Remission of depressive symptoms using the Hamilton Depression Rating Scale (HAM - D or HDRS) - 17 version
Severity of depressive symptoms being measured pre and post treatment - remission is less than 8 (low score is less depression, higher score - more depressive symptoms, range is 0 to 53)
Time frame: at screening (within a week of starting treatment) to a week post treatment
Response to treatment with reduction of 50% in depressive symptoms on HAM-D - 17 and PHQ - 9 (patient health questionnaire)
Change in severity of depressive symptoms (same as primary outcome description)
Time frame: at screening (within a week of starting treatment) to a week post treatment
Response of anxiety symptoms - reduction by 50% - Generalized Anxiety disorder scale (GAD-&)
Change in severity of anxiety symptoms - higher the score, more anxiety symptoms, range 0 to 21
Time frame: at screening (within a week of starting treatment) to a week post treatment
Change in World Health Organization Disability assessment scale (WHODAS)
severity of disability ( 40 to 180 - higher score = more disabled)
Time frame: at screening (within a week of starting treatment) to a week post treatment
Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (QUAL-ES-Q)
Change in rated quality of life, score range from 14 to 70 ( higher score = better quality of life)
Time frame: at screening (within a week of starting treatment) to a week post treatment
Improvement overall using the Clinical Global Severity/Impression Scale (CGI-I)
Change in severity of illness (1 - much worse, 7 - most improved)
Time frame: at screening (within a week of starting treatment) to a week post treatment
Patient Health Questionnaire (PHQ-9) - Response to symptoms
reduction in depression score by 50% - higher the score - more depressive symptoms, scored from 0 to 27
Time frame: at screening (within a week of starting treatment ) to a week post treatment
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