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

Czech Health Research Agency0 个研究点目标入组 60 人开始时间: 2022年7月26日最近更新: 2023年11月20日

试验速览

暂无简介。

•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
•6. Pregnancy or breastfeeding
•7. Patients with severe somatic disorders (cardiovascular disease, neoplasms, endocrinology disorders, etc) that could be associated with depression due to somatic diseases
•8. Patients treated with electroconvulsive therapy less than 3 months before enrollment or suffering from neurologic disorder (e.g., epilepsy, head trauma with loss of consciousness) and patients using any treatment which can strongly affect EEG
•9. Application of other concomitant medication that is not allowed in protocol (e.g. antipsychotics, mood stabilizers, etc.)
•10. Unsuccessful treatment with more than one SSRI antidepressants or rTMS treatment in the current episode of MDD
•11. Fluoxetine treatment before the enrollment in the study

发起方

Czech Health Research Agency