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

árodní ústav duševního zdraví0 个研究点目标入组 60 人开始时间: 2015年5月4日最近更新: 2019年12月16日

适应症

试验速览

暂无简介。

•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
•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 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Psychiatric comorbidity on axis I and II according to DSM IV in the 6 months before enrollment to
•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 injuryand 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 month 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 MDD.
•11. Fluoxetine treatment before the enrollment to the study

发起方

árodní ústav duševního zdraví