Depressive disorder Mental and Behavioural Disorders
Conditions
Interventions
Following an initial wash-out period (2-5 days), eligible subjects will receive a 6-week treatment. They will be randomly allocated in a 1:1:1 ratio (no stratification) to either dmPFC-rTMS +SSRI, HF-
Sponsors
Czech Health Research Agency
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the severity of depressive episodes measured using the Montgomery and Åsberg depression rating scale (MADRS) score from baseline to week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response to treatment, defined as a reduction of total MADRS score = 50%, after 6 weeks of treatment 2. Remission defined as an increase in MADRS =10 points at the end of the study 3. Number of drop-outs from the study for any reason measured using the number of subjects who do not finish the study treatment from baseline to week 6 | — |
Countries
Czech Republic
Outcome results
None listed