The efficacy of transcranial direct current stimulation (tDCS) in the treatment of depression and brain functional changes compared to venlafaxine

Not Applicable

Completed

• Conditions: Depression; Mental and Behavioural Disorders; Resistant depressive disorder

• Registration Number: ISRCTN93220632
• Lead Sponsor: Ministry of Health, Czech Republic

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31695391 results (added 02/04/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-02
• Study Completion: 2019-04-24
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

1. Patients suffering from major depressive disorder (recurrent or single episode) diagnosed according to Diagnostic and Statistical Manual of the American Psychiatric Association-IV. revision criteria, confirmed using The Mini-International Neuropsychiatric Interview - M.I.N.I., Czech version 5.0.0
2. Patients fulfilling at least Stage I criteria for resistant depression according to Thase and Rush (=1 previous, unsuccessful, adequate, antidepressant treatment)
3. The mental ability to understand and sign Informed Consent Form
4. The score in the Montgomery and Åsberg Rating Scale (MADRS) =25 and the score in Clinical Global Impression =4
5. Inpatients in the double-blind phase of treatment
6. Age between 18 and 65 years
7. Right handedness

Exclusion Criteria

1. Psychiatric comorbidity on axis I and II according to DSM IV in the 6 months before enrollment to the study
2. Psychotic, bipolar disorder or dementia in the history
3. Contraindications of venlafaxine treatment according to SPC
4. Contraindications of MRI (metallic plates in the head, applied pacemaker or other electronic
stimulation devices, etc.)
5. Contraindications of tDCS (skin disease, superficial injury and fracture or infraction of skull in the stimulation area, epilepsy, metallic plates in the head)
6. Pregnancy or breast-feeding
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 venlafaxine or tDCS in the current episode of depressive disorder
11. Fluoxetine treatment before the enrollment to the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Double-blind study:<br> 1. Response to treatment with both interventions measured as =50% reduction of MADRS (Montgomery and Åsberg Rating Scale) score at the end of the study (week 4)<br> 2. The number of participants who drop-out from the study for any reason in either study group during the duration of the study<br> 3.The ratio of occurrence of a priory defined predictor (reduction of prefrontal cordance value) in responders and non-responders to both interventions measured after the first week of treatment<br><br> Open-label, follow-up study:<br> The number of patients suffering from relapse of depression defined as the score =20 points in the MADRS in combination with score 4 or more points in the CGI at the time of follow-up visits or need of change of antidepressant treatment due to substantial worsening of clinical status during the duration of the open-label follow-up study (8 weeks)<br>