The aim is to evaluate the evaluate the clinical interest and the safety of repetitive transcranial magnetic stimulation (rTMS) delivered as intermittent Theta burst stimulation(iTBS) on severity of depression in patients with treatment-resistant bipolar disorder.
Methods: A double-blind randomized sham-controlled pilot study will be conducted in 40 patients with bipolar treatment-resistant depression receiving either active (n=20) or sham (n=20) iTBS over the left dorsolateral prefrontal cortex. Depression severity will be assessed by an investigator blinded to iTBS condition before and after 10 to 30 iTBS sessions depending on remission onset. Remission will be defined as Beck Depression Inventory, BDI score\<10. Objective/Hypothesis: The investigators hypothesized the superiority of active iTBS over sham ITBS
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
20
Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a figure-eight coil (MCF-B65)
Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a sham figure-eight coil (MCF-P-B65)
Beck Depression Inventory
Self-reported clinical scale with 13 items
Time frame: 2 time point measure, before and after the end of stimulation sessions (changes from baseline BDI scores at 6 weeks)
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