ISRCTN93220632
Completed
未知
The efficacy of transcranial direct current stimulation (tDCS) in the treatment of depression and brain functional changes compared to venlafaxine: A four week, double-blind, parallel, randomized study with an eight week, open-label, follow-up study
Ministry of Health, Czech Republic0 sites57 target enrollmentOctober 2, 2015
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Ministry of Health, Czech Republic
- Enrollment
- 57
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31695391 results (added 02/04/2020)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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