Effect of Intermittent ThetaBurst Stimulation in Treatment-resistant Bipolar Depression
- Conditions
- Bipolar Depression
- Registration Number
- NCT02740244
- Lead Sponsor
- Hôpital le Vinatier
- Brief 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.
- Detailed 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
- Bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, DSM-IV criteria
- Montgomery and Asberg depression scale > 20
- other psychiatric features, rapid cycles
- Benzodiazepines intake
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Beck Depression Inventory 2 time point measure, before and after the end of stimulation sessions (changes from baseline BDI scores at 6 weeks) Self-reported clinical scale with 13 items
- Secondary Outcome Measures
Name Time Method