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

Nantes University Hospital1 site in 1 country60 target enrollmentJune 2015

ConditionsDEPRESSION

Overview

Phase: N/A
Intervention: Not specified
Conditions: DEPRESSION
Sponsor: Nantes University Hospital
Enrollment: 60
Locations: 1
Primary Endpoint: Therapeutic response rate
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

March 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nantes University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

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.