The aim of this randomized, single-blind trial is to evaluate the effectiveness and tolerability of high frequency or low frequency repetitive transcranial magnetic stimulation (rTMS) in patients with resistant bipolar depression. Patients will be assigned to receive either high or low frequency rTMS for 20 consecutive workdays (4 weeks). 10 Hz (high) frequency rTMS and 1 Hz (low) frequency rTMS will be given over the left or right dorsolateral prefrontal cortex (DLPFC), respectively. Patients will be assessed with several psychometric instruments at baseline, and at weeks 5 and 9.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
8
1 Hz in 1 train of 20-minute duration (1,200 pulses per session) at 120% of the rMT.
10 Hz in 75 trains of 4-seconds duration, with 26-seconds intertrain intervals (3,000 pulses per session) at 120% of the rMT.
Neuromodulation Research Clinic, Douglas Mental Health University Institute
Verdun, Quebec, Canada
Montgomery-Asberg Depression Rating Scale (MADRS)
Pre-post neuromodulation treatment reduction on the scores of the MADRS
Time frame: Week 5
21-item Hamilton Depression Rating Scale (HAM-D21)
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean HAM-D21 score. Remission will be considered as a HAM-D21 score ≤ 8.
Time frame: Week 5
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean QIDS-SR score. Remission will be considered as a QIDS-SR score ≤ 5.
Time frame: Week 5
Quick Inventory of Depressive Symptomatology - Clinician (QIDS-C)
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean QIDS-C score. Remission will be considered as a QIDS-C score ≤ 5.
Time frame: Week 5
Montogmery-Asberg Depression Rating Scale (MADRS)
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean MADRS score. Remission will be defined as a MADRS score ≤ 6.
Time frame: Week 5
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