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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nantes University Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Therapeutic response rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
High Frequency Left repetitive
High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks Magventure Cool B65 Coil with Magpro X100
Intervention: Transcranial magnetic stimulation (Device)
intermittent Theta Burst Stimulation (iTBS)
intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks Magventure Cool B65 Coil with Magpro X100
Intervention: Transcranial magnetic stimulation (Device)
Outcomes
Primary Outcomes
Therapeutic response rate
Time Frame: 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 Outcomes
- Relapse rate(6 months)
- Quality of life(6 months)
- Measures of cortical excitability(6 months)