Trial Summary
What is the purpose of this trial?This trial will compare active intermittent theta burst stimulation (iTBS) rTMS in an accelerated treatment schedule (8 treatment sessions per day for 5 days) to a placebo control. Depression symptom severity will be measured before, during, at end of treatment, 1-week post and 4-weeks post treatment.
Eligibility Criteria
This trial is for outpatients aged 18-65 with major depressive disorder, who haven't responded well to antidepressants or can't tolerate them. Participants must have a certain depression score, be able to follow the treatment schedule, and not be on new psychotropic meds for the last 4 weeks. Exclusions include unstable medical conditions, metal implants near the head, pregnancy, certain psychiatric diagnoses like bipolar or schizophrenia, substance abuse within 3 months, high risk of suicide or taking specific medications.Inclusion Criteria
I am between 18 and 65 years old.
My depression hasn't improved after trying at least one strong antidepressant or I couldn't tolerate 2 different ones.
I am not currently hospitalized.
Exclusion Criteria
I have had ECT treatment before that did not work for me.
I do not have major brain or nerve conditions like severe head injury, Parkinson's, or multiple sclerosis.
I do not have a serious unstable illness, pacemaker, or implanted medication pump.
I take no more than 2 mg of lorazepam daily or any anticonvulsant.
Treatment Details
The study tests an accelerated schedule of active intermittent theta burst stimulation (iTBS) against a placebo control over five days. iTBS is a type of repetitive transcranial magnetic stimulation (rTMS), which uses magnetic fields to stimulate nerve cells in the brain. Depression severity will be measured at multiple points before and after treatment.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active iTBSExperimental Treatment1 Intervention
Administered 8 times daily at approximately 50 minutes intervals (between session end and start) for 5 days. Each session will deliver 1800 pulses of active iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duty cycle of 2 seconds on, 8 seconds off, over 60 cycles / \~10 minutes) at a target intensity of 110% of the subject's resting motor threshold.
Group II: Sham iTBSPlacebo Group1 Intervention
Administered 8 times daily at approximately 50 minutes intervals (between session end and start) for 5 days, using a sham coil that reproduces auditory and tactile sensations of stimulation and has an identical external appearance. Each session will deliver 1800 pulses of sham iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duty cycle of 2 seconds on, 8 seconds off, over 60 cycles / \~10 minutes) at a target intensity of 110% of the subject's resting motor threshold.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Toronto Western Hospital, University Health NetworkToronto, Canada
University of British ColumbiaVancouver, Canada
CAMHToronto, Canada
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Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
University Health Network, TorontoCollaborator
University of British ColumbiaCollaborator