Examining non-invasive brain stimulation for the treatment of depressio

Not Applicable

• Conditions: Depressive disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN26184028
• Lead Sponsor: Czech Health Research Agency

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-26
• Last Update Posted: 20 November 2023
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified