Efficacy of Intermittent ThetaBurst Stimulation Compared to 10 Hz Stimulation on Dorsolateral Prefrontal Cortex in Treatment Resistant Major Depressive Disorder: a Double-blind Randomized Study
Not Applicable
Completed
- Conditions
- DEPRESSION
- Registration Number
- NCT02376491
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
This trial will compare innovating stimulation parameters, intermittent Theta Burst Stimulation, to the standard high frequency stimulation protocol. The Left dorsolateral prefrontal cortex, targeted by MRI navigation will be the site of stimulation in both treatment conditions. The study seeks to determine if there is a superiority in therapeutic efficacy with iTBS protocol compared to conventional one.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Age 18 years to 75 years
- Both gender eligible
- Volontary and able to give consent
- Major depressive episode (MADRS > 20) single or recurrent
- Resistance to at least 2 antidepressants ,
- Treated by antidepressant at efficient stable posology since more than 6 weeks
Exclusion Criteria
- Initiation or modification of antidepressant drug
- Neurodegenerative diseas
- Bipolar I, II disorder
- Schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
- Substance abuse in past 15 days
- Substance dependence not weaned
- Benzodiazepine and any anticonvulsant during rTMS treatment course
- ECT failure in medical history
- Contra-indication to rTMS and MRI
- Pregnancy
- Difficulty to obtain informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Therapeutic response rate 6 months Primary outcome will be therapeutic response rate corresponding to with MADRS score improvement \> 50 % in each group at the end of TMS sessions and one month after.
A final score of \<8 is categorized as remission.
- Secondary Outcome Measures
Name Time Method Relapse rate 6 months Quality of life 6 months Measures of cortical excitability 6 months
Trial Locations
- Locations (1)
CHU de Nantes
🇫🇷Nantes, France
CHU de Nantes🇫🇷Nantes, France