Effect of Intermittent ThetaBurst Stimulation in Treatment-resistant Bipolar Depression

Effects of Intermittent Theta Burst Stimulation Applied Over the Left Dorsolateral Prefrontal Cortex in Patients With Treatment-resistant Bipolar Depression

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

Inclusion Criteria:

• Bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, DSM-IV criteria
• Montgomery and Asberg depression scale > 20

Exclusion Criteria:

• other psychiatric features, rapid cycles
• Benzodiazepines intake
• pregnancy