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

    Summary
    EudraCT number
    		 2015-001639-19
    Trial protocol
    		 CZ  
    Global end of trial date
    24 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2021
    First version publication date
    29 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    15-29900A
    Additional study identifiers
    ISRCTN number
    		 ISRCTN93220632
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Narodní ústav duševního zdraví
    Sponsor organisation address
    Topolova 748, Klecany, Czechia, 25067
    Public contact
    2nd Dpt. of the Clinical Division, Národní ústav duševního zdraví, Martin.Bares@nudz.cz
    Scientific contact
    2nd Dpt. of the Clinical Division, Národní ústav duševního zdraví, Martin.Bares@nudz.cz
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Apr 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Apr 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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.
    Protection of trial subjects
    No
    Background therapy
    		 Hydroxyzine up to 100 mg; Zolpidem 10 mg - rescue treatment
    Evidence for comparator
    		 Venlafaxine as a first line treatment of depressive disorder according to international guidelines for treatment of depression.
    Actual start date of recruitment
    03 Aug 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 2 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czechia: 57
    Worldwide total number of subjects
    57
    EEA total number of subjects
    57
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    57
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All territories of the Czech Republic, from October 2015 to March 2019

    Pre-assignment
    Screening details
    		 initial wash out period 2–7 days; assessed for eligibility 323, randomized 57, not meet inclusion criteria 200, declined to participate 62, other reasons 4

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Subject
    Blinding implementation details
    No

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 VNF+sham
    Arm description
    		 venlafaxine + sham direct current stimulation (tDCS)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Venlafaxin Mylan 75 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    75 - 375 mg per day

    Arm title
    		 tDCS
    Arm description
    		 transcranial direct current stimulation + placebo capsules
    Arm type
    		 Experimental

    Investigational medicinal product name
    placebo capsules
    Investigational medicinal product code
    Other name
    placebo
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1-5 capsules a day

    Number of subjects in period 1
    		VNF+sham tDCS
    Started
    28
    29
    baseline
    28
    29
    Completed
    22
    23
    Not completed
    6
    6
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    -
    1
         Lack of efficacy
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VNF+sham
    Reporting group description
    		 venlafaxine + sham direct current stimulation (tDCS)

    Reporting group title
    tDCS
    Reporting group description
    		 transcranial direct current stimulation + placebo capsules

    Reporting group values
    		 VNF+sham tDCS Total
    Number of subjects
    		 28 29 57
    Age categorical
    No additional details
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 28 29 57
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.6 ± 11.7 46.6 ± 13.0 -
    Gender categorical
    Units: Subjects
        Female
    		 19 17 36
        Male
    		 9 12 21
    treatment resistance
    number of subjects who did not respond at least two prevous antidepressant trial
    Units: Subjects
        resistant
    		 11 11 22
        non-resistant
    		 17 18 35
    number of previous depressive epizodes
    number of previous depressive epizodes in subject´s life
    Units: number
        arithmetic mean (standard deviation)
    		 2.1 ± 1.8 1.6 ± 1.8 -
    illness duration (months)
    illness duration (months)
    Units: months
        arithmetic mean (standard deviation)
    		 98.3 ± 83.4 82.9 ± 90.9 -

    End points

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    End points reporting groups
    Reporting group title
    VNF+sham
    Reporting group description
    		 venlafaxine + sham direct current stimulation (tDCS)

    Reporting group title
    tDCS
    Reporting group description
    		 transcranial direct current stimulation + placebo capsules

    Subject analysis set title
    efficacy analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    all randomized patients who received at least one dose or stimulation of allocated treatment

    Primary: a change in the MADRS

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    End point title
    		 a change in the MADRS
    End point description
    End point type
    Primary
    End point timeframe
    4 weeks
    End point values
    		 VNF+sham tDCS
    Number of subjects analysed
    28
    29
    Units: point
        arithmetic mean (confidence interval 95%)
    9.64 (6.20 to 13.09)
    7.69 (5.09 to 10.29)
    Statistical analysis title
    		 efficacy analyses
    Comparison groups
    VNF+sham v tDCS
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 efficacy
    Comparison groups
    VNF+sham v tDCS
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.25
         upper limit
    		 6.16

    Secondary: remission rate

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    End point title
    		 remission rate
    End point description
    MADRS score lower or equal to 10 points at week 4
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 VNF+sham tDCS
    Number of subjects analysed
    28
    29
    Units: number
        number (not applicable)
    9
    5
    Statistical analysis title
    		 comparison of remission rates between groups
    Comparison groups
    VNF+sham v tDCS
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    overal trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    VNF+sham
    Reporting group description
    		 venlafaxine + sham direct current stimulation (tDCS)

    Reporting group title
    tDCS
    Reporting group description
    		 transcranial direct current stimulation + placebo capsules

    Serious adverse events
    		 VNF+sham tDCS
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    mania
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 VNF+sham tDCS
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 28 (60.71%)
    20 / 29 (68.97%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 28 (39.29%)
    10 / 29 (34.48%)
         occurrences all number
    50
    40
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    15 / 28 (53.57%)
    15 / 29 (51.72%)
         occurrences all number
    15
    15
    Insomnia
         subjects affected / exposed
    12 / 28 (42.86%)
    12 / 29 (41.38%)
         occurrences all number
    20
    20
    sleepiness
         subjects affected / exposed
    17 / 28 (60.71%)
    19 / 29 (65.52%)
         occurrences all number
    35
    40

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    no
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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