Transcranial direct current stimulation and venlafaxine in the treatment of depression

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001639-19-CZ

Enrollment

Registered

2015-05-04

Start date

2015-06-17

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive disorder

Interventions

Trade Name: Venlafaxin Mylan 75 mg Pharmaceutical Form: Capsule, hard INN or Proposed INN: VENLAFAXINE HYDROCHLORIDE Other descriptive name: VENLAFAXINE HYDROCHLORIDE Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion 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 (=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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of 4-week, double-blind and subsequent 8-week, open-label studies is to compare efficacy and tolerability of transcranial direct current stimulation and venlafaxine in the acute treatment of depression and relapse prevention.;Secondary Objective: The secondary objectives of the study is to evaluate efficacy of the change of the prefrontal theta cordance in the prediction of response to venlafaxine and transcranial direct current stimulation and to map basal status and changes associated with treatment with both interventions in terms of various EEG parameters and functional connectivity (LORETA, fMRI);Primary end point(s): 1. Response to treatment will be defined as reduction of total MADRS score = 50% after 4 weeks of treatment in the acute phase of the study. 2.elapse will be 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 change of antidepressant treatment due to substantial worsening of clinical status in the follow-up phase of the study (8 weeks);Timepoint(s) of evaluation of this end point: 1.Response: at the end of the acute phase of the study (4 weeks) 2.Relapse: at the end of the follow- up phase of the study (8 weeks) or at the time of subject´s drop-out	—

Measure

Time frame

Main Objective: The main objective of 4-week, double-blind and subsequent 8-week, open-label studies is to compare efficacy and tolerability of transcranial direct current stimulation and venlafaxine in the acute treatment of depression and relapse prevention.;Secondary Objective: The secondary objectives of the study is to evaluate efficacy of the change of the prefrontal theta cordance in the prediction of response to venlafaxine and transcranial direct current stimulation and to map basal status and changes associated with treatment with both interventions in terms of various EEG parameters and functional connectivity (LORETA, fMRI);Primary end point(s): 1. Response to treatment will be defined as reduction of total MADRS score = 50% after 4 weeks of treatment in the acute phase of the study. 2.elapse will be 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 change of antidepressant treatment due to substantial worsening of clinical status in the follow-up phase of the study (8 weeks);Timepoint(s) of evaluation of this end point: 1.Response: at the end of the acute phase of the study (4 weeks) 2.Relapse: at the end of the follow- up phase of the study (8 weeks) or at the time of subject´s drop-out

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Secondary

Measure	Time frame
Secondary end point(s): 1. Decrease of prefrontal theta cordance value at week 1 comparing to baseline in subsequent responders and non-responders in the acute phase of the study 2. The change of EEG parameters and functional connectivity (LORETA, fMRI) in responders and non-responders in the acute phase of the study;Timepoint(s) of evaluation of this end point: 1. Decrease of prefrontal theta cordance value at week 1 comparing to baseline in subsequent responders and non-responders - week 1 2. The change of EEG parameters and functional connectivity (LORETA, fMRI) in responders and non-responders - week 1, week 4 of the acute phase of the study.	—

Measure

Time frame

Secondary end point(s): 1. Decrease of prefrontal theta cordance value at week 1 comparing to baseline in subsequent responders and non-responders in the acute phase of the study 2. The change of EEG parameters and functional connectivity (LORETA, fMRI) in responders and non-responders in the acute phase of the study;Timepoint(s) of evaluation of this end point: 1. Decrease of prefrontal theta cordance value at week 1 comparing to baseline in subsequent responders and non-responders - week 1 2. The change of EEG parameters and functional connectivity (LORETA, fMRI) in responders and non-responders - week 1, week 4 of the acute phase of the study.

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Countries

Czech Republic

Contacts

Public Contact2nd Dpt. of the Clinical Division

Národní ústav duševního zdraví

Martin.Bares@nudz.cz

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026