Dorsomedial prefrontal cortex repetitive transcranial magnetic stimulation in the augmentation of antidepressants (DOPRERA study). Efficacy, tolerability and neurophysiological changes

Czech Health Research Agency0 sites60 target enrollmentJuly 26, 2022

Overview

No summary available.

Registry

who.int

Start Date

July 26, 2022

End Date

December 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Czech Health Research Agency

•1\. Patients (outpatients or inpatients) suffering from MDD (recurrent or single episode) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM\-V), confirmed using The Mini\-International Neuropsychiatric Interview \- M.I.N.I., Czech Translation version 7\.0\.2 33,34
•2\. Patients fulfilling at least Stage I (\=1 previous, unsuccessful, adequate, antidepressant treatment) criteria for resistant depression according to Thase and Rush
•3\. The mental ability to understand and sign the Informed Consent Form
•4\. The score on the Montgomery and Åsberg Rating Scale (MADRS) \=25
•5\. Aged 18\-70 years old
•6\. Right\-handedness
•7\. Duration of current episode of depression \>1 but \= 12 months

•1\. History of any other DSM\-V diagnosis other than MDD, except anxiety disorders in the last year
•2\. Personality disorder that makes participation in the trial difficult
•3\. History of substance dependence in the last year except nicotine
•4\. Contraindications of SSRI´s treatment according to SPC
•5\. Contraindications of rTMS:
•5\.1\. History of epilepsy or any neurologic condition likely to increase risk of seizure
•5\.2\. Mass brain lesions
•5\.3\. Cerebrovascular accident
•5\.4\. Metal in the head
•5\.5\. History of major head trauma with unconsciousness