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 (THETA-DEP)

Nantes University Hospital (NUH)

Status

Completed

Conditions

DEPRESSION

Treatments

Device: Transcranial magnetic stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02376491

RC14_0375

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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