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    Clinical Trial Results:
    An interventional, randomised, double-blind, parallel-group, placebo-controlled study on the efficacy of vortioxetine on cognitive dysfunction in patients with partial or full remission of major depressive disorder

    Summary
    EudraCT number
    		 2014-000229-19
    Trial protocol
    		 EE   DE   FI   SK  
    Global end of trial date
    25 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2017
    First version publication date
    29 Mar 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    15905A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02279953
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark, 2500
    Public contact
    Lundbeck Clinical Trials, H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    Lundbeck Clinical Trials, 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
    25 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of vortioxetine (10 to 20 mg/day) as adjunctive treatment to stable selective serotonin reuptake inhibitor (SSRI) dose versus stable SSRI monotherapy on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning and attention) in patients who are in partial or full remission from their Major Depressive Episode (MDE).
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH Good Clinical Practice (1996)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Oct 2014
    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
    Slovakia: 9
    Country: Number of subjects enrolled
    Estonia: 31
    Country: Number of subjects enrolled
    Finland: 79
    Country: Number of subjects enrolled
    Germany: 23
    Country: Number of subjects enrolled
    Serbia: 9
    Worldwide total number of subjects
    151
    EEA total number of subjects
    142
    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)
    150
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 In- or out patients who: had achieved either partial or full remission of major depressive disorder (MDD) diagnosed according to DSM-IV-TR™ criteria, had a Hamilton Depression Rating Scale 17-items (HAM-D17) total score ≤10, had received SSRI monotherapy for the current MDD, had a Perceived Deficits Questionnaire – Depression (PDQ-D) total score>25

    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 10-20 mg + placebo
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    vortioxetine
    Investigational medicinal product code
    Other name
    Brintellix
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 or 20mg vortioxetine encapsulated table administered once daily orally. The initial treatment dose of vortioxetine was 10mg/day. Based on the investigator judgement there was a possibility to increase the dose with a 10mg increment to 20mg/day at Week 1.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Powder filled capsule orally once daily

    Arm title
    		 SSRI + placebo
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Escitalopram
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Escitalopram 5, 10, 15, or 20mg/day; encapsulated tablets, orally at current stable dose

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Powder filled capsule orally once daily

    Investigational medicinal product name
    Citalopram
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Citalopram – 10, 20, 30, or 40mg/day; encapsulated tablets, orally at current stable dose

    Investigational medicinal product name
    Sertraline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sertraline – 50, 100, 150, or 200mg/day; encapsulated tablets, orally at current stable dose

    Arm title
    		 Vortioxetine 10-20 mg + SSRI
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioxetine
    Investigational medicinal product code
    Other name
    Brintellix
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 or 20mg vortioxetine encapsulated table administered once daily orally. The initial treatment dose of vortioxetine was 10mg/day. Based on the investigator judgement there was a possibility to increase the dose with a 10mg increment to 20mg/day at Week 1.

    Investigational medicinal product name
    Escitalopram
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Escitalopram 5, 10, 15, or 20mg/day; encapsulated tablets, orally at current stable dose

    Investigational medicinal product name
    Citalopram
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Citalopram – 10, 20, 30, or 40mg/day; encapsulated tablets, orally at current stable dose

    Investigational medicinal product name
    Sertraline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sertraline – 50, 100, 150, or 200mg/day; encapsulated tablets, orally at current stable dose

    Number of subjects in period 1
    		Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Started
    50
    49
    52
    Completed
    47
    44
    47
    Not completed
    3
    5
    5
         Adverse event, non-fatal
    1
    2
    3
         Lost to follow-up
    1
    -
    -
         Administrative reason
    1
    1
    1
         Lack of efficacy
    -
    1
    -
         Protocol deviation
    -
    1
    -
         Non complicance
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Vortioxetine 10-20 mg + placebo
    Reporting group description
    		 -

    Reporting group title
    SSRI + placebo
    Reporting group description
    		 -

    Reporting group title
    Vortioxetine 10-20 mg + SSRI
    Reporting group description
    		 -

    Reporting group values
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI Total
    Number of subjects
    		 50 49 52 151
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 49 49 52 150
        From 65-84 years
    		 1 0 0 1
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.6 ± 10 47.9 ± 11.5 45.9 ± 12.7 -
    Gender categorical
    Units: Subjects
        Female
    		 34 34 41 109
        Male
    		 16 15 11 42
    Race
    Units: Subjects
        White
    		 50 49 52 151

    End points

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    End points reporting groups
    Reporting group title
    Vortioxetine 10-20 mg + placebo
    Reporting group description
    		 -

    Reporting group title
    SSRI + placebo
    Reporting group description
    		 -

    Reporting group title
    Vortioxetine 10-20 mg + SSRI
    Reporting group description
    		 -

    Primary: Change from baseline to Week 8 in Digit Symbol Substitution Test (DSST)

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    End point title
    		 Change from baseline to Week 8 in Digit Symbol Substitution Test (DSST)
    End point description
    Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning)
    End point type
    Primary
    End point timeframe
    Baseline to Week 8
    End point values
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Number of subjects analysed
    48
    47
    48
    Units: Score
        least squares mean (standard error)
    8.1 ± 1.16
    7.94 ± 1.15
    7.9 ± 1.14
    Statistical analysis title
    		 Vortioxetine + SSRI vs SSRI + placebo
    Comparison groups
    SSRI + placebo v Vortioxetine 10-20 mg + SSRI
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9769
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.17
         upper limit
    		 3.08
    Statistical analysis title
    		 Vortioxetine + placebo vs SSRI + placebo
    Comparison groups
    SSRI + placebo v Vortioxetine 10-20 mg + placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9191
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.98
         upper limit
    		 3.3
    Statistical analysis title
    		 Vortioxetine + placebo vs vortioxetine + SSRI
    Comparison groups
    Vortioxetine 10-20 mg + placebo v Vortioxetine 10-20 mg + SSRI
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8954
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.91
         upper limit
    		 3.32

    Secondary: Change from baseline to Week 8 in University of San Diego Performance-based Skills Assessment – Brief (UPSA-B) total score

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    End point title
    		 Change from baseline to Week 8 in University of San Diego Performance-based Skills Assessment – Brief (UPSA-B) total score
    End point description
    The UPSA-B is a role-play based performance test designed to assess functional skills in patients with mental illness. The UPSA-B consists of two subscales: managing finances (for example, counting correct change, writing a check to pay a bill) and communication with others (for example, dialling an emergency telephone number, rescheduling a medical appointment). Raw scores of the two subscales are converted to scaled scores from 0 to 100, where higher scores indicate better functional capacity.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    End point values
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Number of subjects analysed
    48
    47
    48
    Units: Score
        least squares mean (standard error)
    5.99 ± 1.06
    4.28 ± 1.02
    5.24 ± 1.03
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 8 in Rey Auditory Visual Learning Test (RAVLT) scores: Acquisition

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    End point title
    		 Change from baseline to Week 8 in Rey Auditory Visual Learning Test (RAVLT) scores: Acquisition
    End point description
    Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and encoding versus retrieval. The RAVLT consists of a number of tasks where the RAVLT acquisition (learning) is the total number of correctly recalled words from three lists of words with a possible score between 0 and 45. The higher score the better performance
    End point type
    Secondary
    End point timeframe
    Baseline to week 8
    End point values
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Number of subjects analysed
    48
    47
    48
    Units: Score
        least squares mean (standard error)
    4.29 ± 0.66
    3.45 ± 0.66
    2.75 ± 0.66
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 8 in Rey Auditory Visual Learning Test (RAVLT) scores: Delayed call

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    End point title
    		 Change from baseline to Week 8 in Rey Auditory Visual Learning Test (RAVLT) scores: Delayed call
    End point description
    Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and encoding versus retrieval. The RAVLT consists of a number of tasks where RAVLT delayed recall (memory) is the number of correctly recalled words at the end of the test battery from one list of words with a possible score between 0 and 15. The higher score the better performance.
    End point type
    Secondary
    End point timeframe
    Baseline to week 8.
    End point values
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Number of subjects analysed
    48
    47
    48
    Units: Score
        least squares mean (standard error)
    1.43 ± 0.37
    1.46 ± 0.36
    0.82 ± 0.36
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 8 in Trail Making Test A (TMT-A) score

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    End point title
    		 Change from baseline to Week 8 in Trail Making Test A (TMT-A) score
    End point description
    Trail Making Test (TMT) is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B. Part A assesses cognitive processing speed. The lower the score the faster the processing speed.
    End point type
    Secondary
    End point timeframe
    Baseline to week 8
    End point values
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Number of subjects analysed
    48
    47
    48
    Units: Score
        least squares mean (standard error)
    -5.4 ± 1.42
    -1.86 ± 1.4
    -3.55 ± 1.39
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 8 in Trail Making Test B (TMT-B) score

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    End point title
    		 Change from baseline to Week 8 in Trail Making Test B (TMT-B) score
    End point description
    TMT is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B. Part B examines executive functioning and ability to shift cognitive set. The lower the score the faster the ability to shift cognitive set.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8.
    End point values
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Number of subjects analysed
    48
    47
    48
    Units: Score
        least squares mean (standard error)
    -12.33 ± 2.54
    -9.55 ± 2.52
    -10.91 ± 2.5
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 8 in Simple Reaction Time (SRT)

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    End point title
    		 Change from baseline to Week 8 in Simple Reaction Time (SRT)
    End point description
    Simple Reaction Time (SRT) is designed to assess psychomotor speed. The patient presses a "yes" button, whenever an onscreen playing card is turned over. The lower score the better performance.
    End point type
    Secondary
    End point timeframe
    Baseline to week 8
    End point values
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Number of subjects analysed
    47
    47
    46
    Units: Score
        least squares mean (standard error)
    -0.031 ± 0.013
    -0.01 ± 0.013
    -0.019 ± 0.013
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 8 in Choice Reaction Time (CRT)

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    End point title
    		 Change from baseline to Week 8 in Choice Reaction Time (CRT)
    End point description
    Choice Reaction Time (CRT) is designed to assess visual attention. The patient presses a "yes" button whenever an onscreen playing card is turned over and is red, or a "no" button if the card is not red. The lower score the better performance.
    End point type
    Secondary
    End point timeframe
    Baseline to week 8
    End point values
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Number of subjects analysed
    47
    47
    46
    Units: Score
        least squares mean (standard error)
    -0.016 ± 0.011
    -0.014 ± 0.011
    -0.01 ± 0.011
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 8 in Stroop Colour Naming Test (STROOP) score: Congruent

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    End point title
    		 Change from baseline to Week 8 in Stroop Colour Naming Test (STROOP) score: Congruent
    End point description
    Stroop Colour Naming Test (STROOP) is a cognitive test designed to assess the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. The STROOP comprises two sheets with 50 words on each, and each word is the name of a colour. In the Congruent STROOP Sheet, the word and ink colour match. The lower the score the faster the processing speed.
    End point type
    Secondary
    End point timeframe
    Baseline to week 8
    End point values
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Number of subjects analysed
    48
    47
    48
    Units: Score
        least squares mean (standard error)
    -6.58 ± 1.24
    -4.52 ± 1.22
    -7.04 ± 1.22
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 8 in Stroop Colour Naming Test (STROOP) score : Incongruent

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    End point title
    		 Change from baseline to Week 8 in Stroop Colour Naming Test (STROOP) score : Incongruent
    End point description
    Stroop Colour Naming Test (STROOP) is a cognitive test designed to assess the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. The STROOP comprises two sheets with 50 words on each, and each word is the name of a colour. In the Incongruent STROOP Sheet, the word and ink colour do not match. The lower the score the greater the cognitive flexibility.
    End point type
    Secondary
    End point timeframe
    Baseline to week 8.
    End point values
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Number of subjects analysed
    48
    47
    48
    Units: Score
        least squares mean (standard error)
    -8.86 ± 1.83
    -8.69 ± 1.81
    -9.13 ± 1.8
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 8 in Perceived Deficits Questionnaire –Depression (PDQ-D) total score

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    End point title
    		 Change from baseline to Week 8 in Perceived Deficits Questionnaire –Depression (PDQ-D) total score
    End point description
    Patient-reported cognitive function outcome including attention concentration, retrospective memory, prospective memory, and, planning organization. The total score of the 20 items ranges from 0 to 80 with higher scores reflecting greater subjective cognitive dysfunction as perceived by the patient.
    End point type
    Secondary
    End point timeframe
    Baseline to week 8.
    End point values
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Number of subjects analysed
    48
    47
    48
    Units: Score
        least squares mean (standard error)
    -15.71 ± 1.63
    -13.11 ± 1.62
    -15.58 ± 1.61
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 8 in Hamilton Depression Rating Scale 17 items (HAM-D17) total score

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    End point title
    		 Change from baseline to Week 8 in Hamilton Depression Rating Scale 17 items (HAM-D17) total score
    End point description
    The Hamilton Depression Rating Scale (HAM-D17) is a 17-item rating scale designed to measure the severity of depressive symptoms in patients with primary depressive illness. It includes psychological and somatic depressive symptoms. The rating is based on specific statements, content of the answers, tone, facial expression and gestures of the patient during a clinical interview. Total score from 0-52. The higher the score, the more severe.
    End point type
    Secondary
    End point timeframe
    Baseline to week 8.
    End point values
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Number of subjects analysed
    47
    44
    47
    Units: Score
        least squares mean (standard error)
    -1.18 ± 0.48
    -0.97 ± 0.48
    -1.8 ± 0.47
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 8 in Clinical Global Impression – Severity of Illness (CGI-S) score

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    End point title
    		 Change from baseline to Week 8 in Clinical Global Impression – Severity of Illness (CGI-S) score
    End point description
    The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
    End point type
    Secondary
    End point timeframe
    Baseline to week 8.
    End point values
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Number of subjects analysed
    47
    44
    47
    Units: Score
        least squares mean (standard error)
    -0.22 ± 0.1
    -0.13 ± 0.1
    -0.25 ± 0.1
    No statistical analyses for this end point

    Secondary: Clinical Global Impression – Global Improvement (CGI-I) score at Week 8

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    End point title
    		 Clinical Global Impression – Global Improvement (CGI-I) score at Week 8
    End point description
    The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse).
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Number of subjects analysed
    47
    44
    47
    Units: Score
        least squares mean (standard error)
    2.98 ± 0.17
    3.35 ± 0.17
    3.14 ± 0.17
    No statistical analyses for this end point

    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
    18.1
    Reporting groups
    Reporting group title
    Vortioxetine 10-20 mg + placebo
    Reporting group description
    		 Vortioxetine 10-20 mg + placebo

    Reporting group title
    SSRI + placebo
    Reporting group description
    		 SSRI + placebo

    Reporting group title
    Vortioxetine 10-20 mg + SSRI
    Reporting group description
    		 Vortioxetine10-20 mg + SSRI

    Serious adverse events
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Vortioxetine 10-20 mg + placebo SSRI + placebo Vortioxetine 10-20 mg + SSRI
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 50 (48.00%)
    11 / 49 (22.45%)
    29 / 52 (55.77%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 50 (12.00%)
    0 / 49 (0.00%)
    2 / 52 (3.85%)
         occurrences all number
    7
    0
    2
    Headache
         subjects affected / exposed
    3 / 50 (6.00%)
    5 / 49 (10.20%)
    9 / 52 (17.31%)
         occurrences all number
    3
    5
    10
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 49 (2.04%)
    3 / 52 (5.77%)
         occurrences all number
    1
    1
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 50 (8.00%)
    0 / 49 (0.00%)
    4 / 52 (7.69%)
         occurrences all number
    6
    0
    4
    Nausea
         subjects affected / exposed
    11 / 50 (22.00%)
    1 / 49 (2.04%)
    16 / 52 (30.77%)
         occurrences all number
    12
    1
    16
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    3
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 49 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    2
    0
    3
    Restlessness
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    0
    0
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 50 (6.00%)
    4 / 49 (8.16%)
    3 / 52 (5.77%)
         occurrences all number
    3
    4
    3
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 50 (6.00%)
    3 / 49 (6.12%)
    1 / 52 (1.92%)
         occurrences all number
    3
    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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