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    Clinical Trial Results:
    Interventional, randomised, double-blind, parallel-group, placebo-controlled, exploratory study investigating the effects of vortioxetine on cognition and blood oxygen level dependent (BOLD) fMRI signals in subjects remitted from depression and controls

    Summary
    EudraCT number
    		 2011-001839-23
    Trial protocol
    		 GB  
    Global end of trial date
    23 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jul 2016
    First version publication date
    05 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    14137A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01607125
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark, 2500
    Public contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com
    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
    23 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether vortioxetine compared to placebo in subjects remitted from depression modulates the blood oxygen level dependent (BOLD) signal in functional magnetic resonance imaging (fMRI) of the brain areas associated with executive function (working memory) during performance of the N-back task. The regions of interest are within the prefrontal cortex and anterior cingulate. To determine whether vortioxetine compared to placebo in subjects remitted from depression modulates the blood oxygen level dependent (BOLD) signal in functional magnetic resonance imaging (fMRI) of the brain areas associated with spatial memory during performance of the Arena task. The region of interest is hippocampus. To evaluate the effects of vortioxetine compared to placebo in subjects remitted from depression on the BOLD signal in fMRI in other brain regions involved in the regulation of cognitive processes during working memory and planning performance (N-back and Arena task).
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2008) and ICH Good Clinical Practice (1996)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jul 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 101
    Worldwide total number of subjects
    101
    EEA total number of subjects
    101
    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)
    101
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited by 4 investigators at 3 centres in the United Kingdom

    Pre-assignment
    Screening details
    		 Subjects who met each of the inclusion and none of the exclusion criteria were eligible to participate in the study

    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
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Vortioxetine 20 mg qd (controls)
    Arm description
    		 Subjects in the control group had no history of major depressive episodes (MDEs) and no history of MDEs in a biological parent or other first degree relative (as reported by the subject). Subjects had not reported subjective cognitive dysfunction and had never been treated with antidepressants or psychotherapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioxetine
    Investigational medicinal product code
    Other name
    Lu AA21004
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    encapsulated 20 mg tablets, orally, once daily for 13 to 14 days

    Arm title
    		 Placebo (controls)
    Arm description
    		 Subjects in the control group had no history of MDEs and no history of MDEs in a biological parent or other first degree relative (as reported by the subject). Subjects had not reported subjective cognitive dysfunction and had never been treated with antidepressants or psychotherapy
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    capsules, orally, once daily for 13 to 14 days

    Arm title
    		 Vortioxetine 20 mg qd (subjects remitted from depression)
    Arm description
    		 Subjects remitted from depression had been in remission from recurrent depression, had suffered from at least two previous major depressive episodes (MDEs), and had received prescribed treatment with an antidepressant or a recognised psychotherapy for depression for a previous MDE. The subjects reported present subjective cognitive dysfunction. They had not been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to the screening visit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioxetine
    Investigational medicinal product code
    Other name
    Lu AA21004
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    encapsulated 20 mg tablets, orally, once daily for 13 to 14 days

    Arm title
    		 Placebo (subjects remitted from depression)
    Arm description
    		 Subjects remitted from depression had been in remission from recurrent depression, had suffered from at least two previous major depressive episodes (MDEs), and had received prescribed treatment with an antidepressant or a recognised psychotherapy for depression for a previous MDE. The subjects reported present subjective cognitive dysfunction. They had not been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to the screening visit.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    capsules, orally, once daily for 13 to 14 days

    Number of subjects in period 1
    		Vortioxetine 20 mg qd (controls) Placebo (controls) Vortioxetine 20 mg qd (subjects remitted from depression) Placebo (subjects remitted from depression)
    Started
    25
    25
    26
    25
    Completed
    24
    24
    24
    24
    Not completed
    1
    1
    2
    1
         Physician decision
    1
    1
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Vortioxetine 20 mg qd (controls)
    Reporting group description
    		 Subjects in the control group had no history of major depressive episodes (MDEs) and no history of MDEs in a biological parent or other first degree relative (as reported by the subject). Subjects had not reported subjective cognitive dysfunction and had never been treated with antidepressants or psychotherapy

    Reporting group title
    Placebo (controls)
    Reporting group description
    		 Subjects in the control group had no history of MDEs and no history of MDEs in a biological parent or other first degree relative (as reported by the subject). Subjects had not reported subjective cognitive dysfunction and had never been treated with antidepressants or psychotherapy

    Reporting group title
    Vortioxetine 20 mg qd (subjects remitted from depression)
    Reporting group description
    		 Subjects remitted from depression had been in remission from recurrent depression, had suffered from at least two previous major depressive episodes (MDEs), and had received prescribed treatment with an antidepressant or a recognised psychotherapy for depression for a previous MDE. The subjects reported present subjective cognitive dysfunction. They had not been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to the screening visit.

    Reporting group title
    Placebo (subjects remitted from depression)
    Reporting group description
    		 Subjects remitted from depression had been in remission from recurrent depression, had suffered from at least two previous major depressive episodes (MDEs), and had received prescribed treatment with an antidepressant or a recognised psychotherapy for depression for a previous MDE. The subjects reported present subjective cognitive dysfunction. They had not been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to the screening visit.

    Reporting group values
    		 Vortioxetine 20 mg qd (controls) Placebo (controls) Vortioxetine 20 mg qd (subjects remitted from depression) Placebo (subjects remitted from depression) Total
    Number of subjects
    		 25 25 26 25 101
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 25 25 26 25 101
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34 ( 8.9 ) 35 ( 9.6 ) 34 ( 9.1 ) 39 ( 8.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 16 12 18 11 57
        Male
    		 9 13 8 14 44
    Race
    Units: Subjects
        Asian
    		 1 3 2 3 9
        Black or African American
    		 0 0 1 0 1
        White
    		 23 20 23 21 87
        Other
    		 1 2 0 1 4

    End points

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    End points reporting groups
    Reporting group title
    Vortioxetine 20 mg qd (controls)
    Reporting group description
    		 Subjects in the control group had no history of major depressive episodes (MDEs) and no history of MDEs in a biological parent or other first degree relative (as reported by the subject). Subjects had not reported subjective cognitive dysfunction and had never been treated with antidepressants or psychotherapy

    Reporting group title
    Placebo (controls)
    Reporting group description
    		 Subjects in the control group had no history of MDEs and no history of MDEs in a biological parent or other first degree relative (as reported by the subject). Subjects had not reported subjective cognitive dysfunction and had never been treated with antidepressants or psychotherapy

    Reporting group title
    Vortioxetine 20 mg qd (subjects remitted from depression)
    Reporting group description
    		 Subjects remitted from depression had been in remission from recurrent depression, had suffered from at least two previous major depressive episodes (MDEs), and had received prescribed treatment with an antidepressant or a recognised psychotherapy for depression for a previous MDE. The subjects reported present subjective cognitive dysfunction. They had not been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to the screening visit.

    Reporting group title
    Placebo (subjects remitted from depression)
    Reporting group description
    		 Subjects remitted from depression had been in remission from recurrent depression, had suffered from at least two previous major depressive episodes (MDEs), and had received prescribed treatment with an antidepressant or a recognised psychotherapy for depression for a previous MDE. The subjects reported present subjective cognitive dysfunction. They had not been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to the screening visit.

    Primary: N-Back Task: BOLD fMRI activity during the 0 (control), 1, 2 and 3 back conditions of the task

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    End point title
    		 N-Back Task: BOLD fMRI activity during the 0 (control), 1, 2 and 3 back conditions of the task [1]
    End point description
    Of the pre-defined Regions of interest (ROIs), analyses showed a statistically significant effect in the hippocampus only. Thus, in remitted subjects, vortioxetine statistically significantly reduced the blood oxygen level dependent (BOLD) signal in the left hippocampus compared to placebo during the N-back task.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 13
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Main objectives of the study were to study effects of vortioxetine compared to placebo in subjects remitted from depression.
    End point values
    		 Vortioxetine 20 mg qd (subjects remitted from depression) Placebo (subjects remitted from depression)
    Number of subjects analysed
    24
    24
    Units: Activity
        number (not applicable)
    0.2
    0
    Statistical analysis title
    		 Effect of treatment in remitted subjects
    Statistical analysis description
    The effect of treatment was tested using an ANCOVA model with the ‘change from baseline’ as the dependent variable. Only the contrast was available from the analysis in the statistical software program SPM, and therefore the treatment contrast is presented in the vortioxetine group, while the placebo group effect has been set to zero.
    Comparison groups
    Placebo (subjects remitted from depression) v Vortioxetine 20 mg qd (subjects remitted from depression)
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.01
    Method
    		 ANCOVA
    Confidence interval

    Primary: Arena Task: BOLD fMRI activity while performing the encoding and retrieval trials

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    End point title
    		 Arena Task: BOLD fMRI activity while performing the encoding and retrieval trials [2]
    End point description
    Vortioxetine did not influence BOLD activity or the performance measures of spatial memory. Only the p-value for left hippocampus is given since all p-values for regions of interest were non-significant.
    End point type
    Primary
    End point timeframe
    Day 1 to 13
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Main objectives of the study were to study effects of vortioxetine compared to placebo in subjects remitted from depression.
    End point values
    		 Vortioxetine 20 mg qd (subjects remitted from depression) Placebo (subjects remitted from depression)
    Number of subjects analysed
    24
    24
    Units: Activity
        number (not applicable)
    0.06
    0
    Statistical analysis title
    		 Effect of treatment in remitted subjects
    Statistical analysis description
    The effect of treatment was tested using an ANCOVA model with the ‘change from baseline’ as the dependent variable. Only the contrast was available from the analysis in the statistical software program SPM, and therefore the treatment contrast is presented in the vortioxetine group, while the placebo group effect has been set to zero.
    Comparison groups
    Vortioxetine 20 mg qd (subjects remitted from depression) v Placebo (subjects remitted from depression)
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.57
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose to follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Vortioxetine 20 mg qd
    Reporting group description
    		 20 mg vortioxetine once daily for 13 to 14 days

    Reporting group title
    Placebo qd
    Reporting group description
    		 Placebo qd

    Serious adverse events
    		 Vortioxetine 20 mg qd Placebo qd
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Vortioxetine 20 mg qd Placebo qd
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 48 (54.17%)
    22 / 48 (45.83%)
    Nervous system disorders
    Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 48 (12.50%)
    2 / 48 (4.17%)
         occurrences all number
    6
    2
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    14 / 48 (29.17%)
    14 / 48 (29.17%)
         occurrences all number
    17
    17
    General disorders and administration site conditions
    Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 48 (10.42%)
    1 / 48 (2.08%)
         occurrences all number
    5
    1
    Irritability
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 48 (0.00%)
    3 / 48 (6.25%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 48 (6.25%)
    4 / 48 (8.33%)
         occurrences all number
    4
    4
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    10 / 48 (20.83%)
    4 / 48 (8.33%)
         occurrences all number
    12
    4
    Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 48 (0.00%)
         occurrences all number
    5
    0
    Skin and subcutaneous tissue disorders
    Pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 48 (0.00%)
         occurrences all number
    3
    0
    Psychiatric disorders
    Initial insomnia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 48 (0.00%)
         occurrences all number
    3
    0
    Middle insomnia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 48 (6.25%)
    1 / 48 (2.08%)
         occurrences all number
    3
    1

    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.
    None reported
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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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