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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02740244
Study type Interventional
Source Hôpital le Vinatier
Contact
Status Terminated
Phase N/A
Start date January 2011
Completion date January 2015

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