Transcranial direct current stimulation and venlafaxine in the treatment of depressio

Phase 1

• Conditions: Depressive disorder; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2015-001639-19-CZ
• Lead Sponsor: árodní ústav duševního zdraví

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-04
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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 (=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

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified