Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depressive Disorder
Major Depressive Disorder
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depression Disorder, Treatment Resistance, repetitive Transcranial Magnetic Stimulation
Eligibility Criteria
Inclusion Criteria:
- voluntary and competent to consent
- diagnosis of MDD, as confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV)
- 18 - 85 years of age
- failed to achieve clinical response, or did not tolerate, at least 2 separate antidepressant trials of sufficient dosage for at least 6 wks
- have a score of 20 or greater on the HAM-D17
- have not had an increase or initiation of any psychoactive therapy in the 4 wks prior to testing
- if a woman of childbearing potential, must be on an effective means of birth control
Exclusion Criteria:
- history of DSM-IV confirmed diagnosis of substance dependence in the last 6 months, or substance abuse in the last month
- concomitant, major, unstable medical or neurologic illness
- history of seizures
- acutely suicidal and/or homicidal
- pregnant
- have metal implants
- history of psychosurgery
- co-morbid diagnosis of borderline and/or antisocial personality disorder. as confirmed by the SCID for Axis II Disorders (SCID-II)
- are currently (or in the past 4 weeks) taking more than 2 mg of lorazepam, or equivalent, daily
- ECT treatment in the current episode
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Sham Comparator
High-frequency Left rTMS
Bilateral rTMS
Sham rTMS
Intensity: rTMS treatment intensity determined by using resting motor threshold (RMT). Treatment will be delivered at 120% of the RMT. Site of Stimulation: left hemisphere of DLPFC. Frequency: 10 Hz. Duration: 42 Trains, 5 second duration, 25 second inter-train interval.
Intensity: rTMS treatment intensity determined by the RMT. Treatment will be delivered at 120% of the RMT. Sites of Stimulation: right and left hemispheres of the DLPFC. Frequency: 1 Hz over the right DLPFC followed by 10 Hz over the left DLPFC. Duration: right: 1 Train of 600 pulses; left: 30 Trains, 5 second duration, 25 second inter-train interval.
Sham rTMS Treatment is applied as either Bilateral rTMS or HFL-rTMS (randomly assigned), but with the coil angled 90 degrees away from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.