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    Clinical Trial Results:
    An interventional, randomised, double-blind, parallel-group, placebo-controlled, active-referenced (paroxetine), fixed-dose study on the efficacy of vortioxetine on cognitive dysfunction in working patients with major depressive disorder

    Summary
    EudraCT number
    		 2014-000230-34
    Trial protocol
    		 EE   FI   LT   DE   SK  
    Global end of trial date
    05 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2017
    First version publication date
    19 Feb 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    15906A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02279966
    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
    05 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of acute treatment with 10mg/day vortioxetine versus placebo on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning, and attention) in working patients with major depressive disorder (MDD)
    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
    Finland: 57
    Country: Number of subjects enrolled
    Germany: 34
    Country: Number of subjects enrolled
    Estonia: 29
    Country: Number of subjects enrolled
    Lithuania: 32
    Worldwide total number of subjects
    152
    EEA total number of subjects
    152
    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)
    152
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Working outpatients with a primary diagnosis of recurrent MDD according to DSM-IV-TR™ (classification 296.3x), as confirmed using the Mini International Neuropsychiatric Interview (MINI), who had a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening Visit and at the Baseline Visit

    Period 1
    Period 1 title
    Period 1 (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
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Experimental

    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 capsules, orally. 8 weeks of double-blind treatment

    Arm title
    		 Vortioxetine 10 mg/day
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    vortioxetine 10 mg/day
    Investigational medicinal product code
    Other name
    Brintellix, Trintellix
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg/day; encapsulated tablets, orally. 8 weeks of double-blind treatment

    Arm title
    		 Paroxetine 20 mg/day
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paroxetine 20 mg/day
    Investigational medicinal product code
    Other name
    Seroxat®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg/day; encapsulated tablets, orally. 8 weeks of double-blind treatment

    Number of subjects in period 1
    		Placebo Vortioxetine 10 mg/day Paroxetine 20 mg/day
    Started
    49
    48
    55
    Completed
    46
    41
    47
    Not completed
    3
    7
    8
         Adverse event, non-fatal
    1
    3
    3
         Other
    -
    2
    3
         Lack of efficacy
    1
    2
    1
         Not treated
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Vortioxetine 10 mg/day
    Reporting group description
    		 -

    Reporting group title
    Paroxetine 20 mg/day
    Reporting group description
    		 -

    Reporting group values
    		 Placebo Vortioxetine 10 mg/day Paroxetine 20 mg/day Total
    Number of subjects
    		 49 48 55 152
    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 48 55 152
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.2 ± 12.6 47.3 ± 12 46 ± 11.6 -
    Gender categorical
    Units: Subjects
        Female
    		 30 35 37 102
        Male
    		 19 13 18 50
    Race
    Units: Subjects
        White
    		 48 48 54 150
        Black or African American
    		 1 0 0 1
        Other
    		 0 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Vortioxetine 10 mg/day
    Reporting group description
    		 -

    Reporting group title
    Paroxetine 20 mg/day
    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
    		 Placebo Vortioxetine 10 mg/day Paroxetine 20 mg/day
    Number of subjects analysed
    47
    46
    48
    Units: Score
        least squares mean (standard error)
    7.37 ± 1.06
    7.59 ± 1.08
    6.61 ± 1.05
    Statistical analysis title
    		 Vortioxetine vs placebo
    Comparison groups
    Vortioxetine 10 mg/day v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8845
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.76
         upper limit
    		 3.2

    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, dialing 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
    		 Placebo Vortioxetine 10 mg/day Paroxetine 20 mg/day
    Number of subjects analysed
    47
    46
    50
    Units: Score
        least squares mean (standard error)
    5.33 ± 1.11
    5.75 ± 1.13
    5.95 ± 1.08
    Statistical analysis title
    		 Vortioxetine 10 mg vs placebo
    Comparison groups
    Vortioxetine 10 mg/day v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7894
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.69
         upper limit
    		 3.54
    Variability estimate
    Standard error of the mean

    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
    		 Placebo Vortioxetine 10 mg/day Paroxetine 20 mg/day
    Number of subjects analysed
    47
    46
    49
    Units: Score
        least squares mean (standard error)
    -5.02 ± 1.24
    -5.73 ± 1.27
    -7.32 ± 1.22
    Statistical analysis title
    		 Vortioxetine 10 mg vs placebo
    Comparison groups
    Vortioxetine 10 mg/day v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6886
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.23
         upper limit
    		 2.8

    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
    		 Placebo Vortioxetine 10 mg/day Paroxetine 20 mg/day
    Number of subjects analysed
    44
    44
    45
    Units: Score
        least squares mean (standard error)
    -13.98 ± 3.7
    -16.2 ± 3.74
    -13.88 ± 3.64
    Statistical analysis title
    		 Vortioxetine 10 mg vs placebo
    Comparison groups
    Vortioxetine 10 mg/day v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6734
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.65
         upper limit
    		 8.2

    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
    		 Placebo Vortioxetine 10 mg/day Paroxetine 20 mg/day
    Number of subjects analysed
    45
    45
    47
    Units: Scores
        least squares mean (standard error)
    -0.018 ± 0.015
    -0.073 ± 0.015
    -0.024 ± 0.014
    Statistical analysis title
    		 Vortioxetine 10 mg vs placebo
    Comparison groups
    Vortioxetine 10 mg/day v Placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0107
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.055
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.097
         upper limit
    		 -0.013

    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
    		 Placebo Vortioxetine 10 mg/day Paroxetine 20 mg/day
    Number of subjects analysed
    45
    46
    47
    Units: Score
        least squares mean (standard error)
    -0.023 ± 0.011
    -0.038 ± 0.011
    -0.02 ± 0.011
    Statistical analysis title
    		 Vortioxetine 10 mg vs placebo
    Comparison groups
    Placebo v Vortioxetine 10 mg/day
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3193
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.015
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.045
         upper limit
    		 0.015

    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
    		 Placebo Vortioxetine 10 mg/day Paroxetine 20 mg/day
    Number of subjects analysed
    47
    46
    49
    Units: Score
        least squares mean (standard error)
    -6.49 ± 1.13
    -8.74 ± 1.14
    -9.11 ± 1.09
    Statistical analysis title
    		 Vortioxetine 10 mg vs placebo
    Comparison groups
    Vortioxetine 10 mg/day v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1634
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.42
         upper limit
    		 0.93

    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
    		 Placebo Vortioxetine 10 mg/day Paroxetine 20 mg/day
    Number of subjects analysed
    47
    46
    49
    Units: Score
        least squares mean (standard error)
    -11.59 ± 2.14
    -12.44 ± 2.19
    -14.3 ± 2.09
    Statistical analysis title
    		 Vortioxetine 10 mg vs placebo
    Comparison groups
    Placebo v Vortioxetine 10 mg/day
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7814
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.9
         upper limit
    		 5.2

    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
    		 Placebo Vortioxetine 10 mg/day Paroxetine 20 mg/day
    Number of subjects analysed
    47
    45
    49
    Units: Score
        least squares mean (standard error)
    -8.36 ± 1.88
    -15.17 ± 1.91
    -15.26 ± 1.83
    Statistical analysis title
    		 Vortioxetine 10 mg vs placebo
    Comparison groups
    Vortioxetine 10 mg/day v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0122
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.12
         upper limit
    		 -1.51

    Secondary: Change from baseline to Week 8 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score

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    End point title
    		 Change from baseline to Week 8 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
    End point description
    The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. Total score from 0 to 60. The higher the score, the more severe
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    End point values
    		 Placebo Vortioxetine 10 mg/day Paroxetine 20 mg/day
    Number of subjects analysed
    46
    42
    46
    Units: Score
        least squares mean (standard error)
    -8 ± 1.21
    -15.15 ± 1.27
    -15.96 ± 1.19
    Statistical analysis title
    		 Vortioxetine 10 mg vs placebo
    Comparison groups
    Placebo v Vortioxetine 10 mg/day
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.65
         upper limit
    		 -3.65

    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
    		 Placebo Vortioxetine 10 mg/day Paroxetine 20 mg/day
    Number of subjects analysed
    46
    42
    46
    Units: Score
        least squares mean (standard error)
    -0.78 ± 0.17
    -1.69 ± 0.18
    -1.76 ± 0.17
    Statistical analysis title
    		 Vortioxetine 10 mg vs placebo
    Comparison groups
    Vortioxetine 10 mg/day v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 -0.41

    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
    		 Placebo Vortioxetine 10 mg/day Paroxetine 20 mg/day
    Number of subjects analysed
    46
    42
    46
    Units: Score
        least squares mean (standard error)
    3 ± 0.14
    2.13 ± 0.15
    2.04 ± 0.14
    Statistical analysis title
    		 Vortioxetine 10 mg vs placebo
    Comparison groups
    Vortioxetine 10 mg/day v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.27
         upper limit
    		 -0.47

    Secondary: Change from baseline to Week 8 in Functioning Assessment Short Test (FAST) total score

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    End point title
    		 Change from baseline to Week 8 in Functioning Assessment Short Test (FAST) total score
    End point description
    The FAST is a clinician-rating scale designed to assess difficulty in functioning. The FAST assesses 6 specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, leisure time. The total score of the 24 items ranges from 0 to 72 with higher scores reflecting more serious difficulties
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    End point values
    		 Placebo Vortioxetine 10 mg/day Paroxetine 20 mg/day
    Number of subjects analysed
    47
    46
    49
    Units: Score
        least squares mean (standard error)
    -8.26 ± 1.49
    -12.97 ± 1.51
    -10.97 ± 1.46
    Statistical analysis title
    		 Vortioxetine 10 mg vs placebo
    Comparison groups
    Vortioxetine 10 mg/day v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0278
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.9
         upper limit
    		 -0.52

    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
    PLACEBO
    Reporting group description
    		 PLACEBO

    Reporting group title
    Paroxetine 20 MG
    Reporting group description
    		 Paroxetine 20 MG

    Reporting group title
    Vortioxetine 10 MG
    Reporting group description
    		 Vortioxetine 10 MG

    Serious adverse events
    		 PLACEBO Paroxetine 20 MG Vortioxetine 10 MG
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 54 (3.70%)
    0 / 48 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Brain contusion
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 54 (1.85%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 54 (1.85%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pyelonephritis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PLACEBO Paroxetine 20 MG Vortioxetine 10 MG
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 48 (20.83%)
    15 / 54 (27.78%)
    21 / 48 (43.75%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    0 / 48 (0.00%)
    4 / 54 (7.41%)
    0 / 48 (0.00%)
         occurrences all number
    0
    4
    0
    Headache
         subjects affected / exposed
    2 / 48 (4.17%)
    3 / 54 (5.56%)
    7 / 48 (14.58%)
         occurrences all number
    2
    3
    7
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 48 (2.08%)
    9 / 54 (16.67%)
    18 / 48 (37.50%)
         occurrences all number
    1
    10
    19
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed [1]
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 48 (8.33%)
    0 / 54 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    4
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 54 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    3
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 48 (0.00%)
    3 / 54 (5.56%)
    0 / 48 (0.00%)
         occurrences all number
    0
    3
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: gender specific

    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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