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    Clinical Trial Results:
    Interventional, randomized, double-blind, placebo-controlled study of the efficacy and safety of initial administration of 25 mg vortioxetine intravenously with 10 mg/day vortioxetine orally in patients with Major Depressive Disorder

    Summary
    EudraCT number
    		 2018-000992-34
    Trial protocol
    		 LV   EE   BG  
    Global end of trial date
    28 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jul 2020
    First version publication date
    31 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    17915A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03766867
    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, +45 36301311, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    Lundbeck Clinical Trials, H. Lundbeck A/S, +45 36301311, 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
    28 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the efficacy and safety of vortioxetine given as a single intravenous dose of 25 mg at initiation of an oral vortioxetine regimen of 10 mg/day for 7 days
    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
    01 Nov 2018
    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
    Bulgaria: 44
    Country: Number of subjects enrolled
    Estonia: 25
    Country: Number of subjects enrolled
    Latvia: 12
    Worldwide total number of subjects
    81
    EEA total number of subjects
    81
    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)
    79
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    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
    Placebo Lead-in
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Arm title
    		 Placebo
    Arm description
    		 one day single-blind treatment with placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    film-coated tablet, oral administration. one day single-blind treatment with placebo

    Investigational medicinal product name
    Placebo infusion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    concentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose

    Number of subjects in period 1
    		Placebo
    Started
    81
    Completed
    81
    Period 2
    Period 2 title
    Double-blind Period (DBT)
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Vortioxetine
    Arm description
    		 Double-blind Treatment (DBT) Period with vortioxetine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioxetine infusion 25 mg
    Investigational medicinal product code
    Lu AA21004
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vortioxetine – 25mg, IV infusion of 25mL 1mg/mL concentrate for solution for infusion on Day 0

    Investigational medicinal product name
    Vortioxetine tablets 10 mg/day
    Investigational medicinal product code
    Lu AA21004
    Other name
    Brintellix ®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg, tablets, oral administration once daily. 7 tablets for a duration of 7 days

    Arm title
    		 Placebo
    Arm description
    		 Double-blind Treatment (DBT) Period with placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    film-coated tablets, oral administration once daily. 7 tablets for a duration of 7 days

    Investigational medicinal product name
    Placebo infusion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    concentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 1 is the lead-in period of the study
    Number of subjects in period 2 [2] [3]
    		Vortioxetine Placebo
    Started
    39
    41
    Completed
    38
    40
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    1
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: It is correct that not all the patients that enrolled the study started the double bind treatment period which explains that the numbers are not the same.
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: It is correct that the number of subjects starting the DBT period is not consistent with the number completing the preceding lead-in period: not all the patients that enrolled the study started the double bind treatment period which explains that the numbers are not the same.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Vortioxetine
    Reporting group description
    		 Double-blind Treatment (DBT) Period with vortioxetine

    Reporting group title
    Placebo
    Reporting group description
    		 Double-blind Treatment (DBT) Period with placebo

    Reporting group values
    		 Vortioxetine Placebo Total
    Number of subjects
    		 39 41 80
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.26 ( 11.03 ) 46.85 ( 13.65 ) -
    Gender categorical
    Units: Subjects
        Female
    		 28 30 58
        Male
    		 11 11 22
    MADRS-6 subscale score
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 23.41 ( 2.31 ) 22.85 ( 2.20 ) -
    MADRS Total score
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 35.59 ( 3.43 ) 34.66 ( 2.73 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 one day single-blind treatment with placebo
    Reporting group title
    Vortioxetine
    Reporting group description
    		 Double-blind Treatment (DBT) Period with vortioxetine

    Reporting group title
    Placebo
    Reporting group description
    		 Double-blind Treatment (DBT) Period with placebo

    Primary: Change from Baseline (Day 0) to Day 1 (24hours post-infusion) in Montgomery and Åsberg Depression Rating Scale (MADRS)-6 subscale score

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    End point title
    		 Change from Baseline (Day 0) to Day 1 (24hours post-infusion) in Montgomery and Åsberg Depression Rating Scale (MADRS)-6 subscale score
    End point description
    The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.
    End point type
    Primary
    End point timeframe
    From baseline (Day 0) to Day 1 (24 h post-infusion)
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    39
    41
    Units: units on a scale
        least squares mean (standard error)
    -3.55 ( 0.58 )
    -2.76 ( 0.60 )
    Statistical analysis title
    		 Ratio vortioxetine vs placebo
    Statistical analysis description
    The primary efficacy analysis was a mixed model for repeated measures (MMRM) of the change from Baseline to Day 1 in MADRS-6 subscore scale. The model included the following fixed effects: site, Day (1,3, and 7), and treatment; the Baseline MADRS-6 subscale score as a continuous covariate; and the treatmentby-Day interaction; and the Baseline score-by-day interaction. The analysis was based on the missed at random (MAR) assumption including all available observations (observed cases [OC] )
    Comparison groups
    Vortioxetine v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2675
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.19
         upper limit
    		 0.61

    Secondary: Change from Baseline (Day 0) to Day 3 in MADRS-6 subscale

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    End point title
    		 Change from Baseline (Day 0) to Day 3 in MADRS-6 subscale
    End point description
    The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.
    End point type
    Secondary
    End point timeframe
    From baseline (Day 0) to Day 3
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    39
    41
    Units: Units on a scale
        least squares mean (standard error)
    -5.29 ( 0.79 )
    -5.23 ( 0.79 )
    Statistical analysis title
    		 Ratio vortioxetine vs placebo (Day 3)
    Statistical analysis description
    The key secondary efficacy analysis of the continuous variables (change from Baseline in MADRS-6 subscale score), was performed using the same methodology (FAS, MMRM) as for the primary efficacy variable.
    Comparison groups
    Placebo v Vortioxetine
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.08
         upper limit
    		 1.97

    Secondary: Change from Baseline (Day 0) to Day 7 in MADRS-6 subscale score

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    End point title
    		 Change from Baseline (Day 0) to Day 7 in MADRS-6 subscale score
    End point description
    The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.
    End point type
    Secondary
    End point timeframe
    From baseline to day 7
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    38
    41
    Units: units on a scale
        least squares mean (standard error)
    -6.51 ( 0.93 )
    -7.27 ( 0.93 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in MADRS total score at Day 1

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    End point title
    		 Change from Baseline in MADRS total score at Day 1
    End point description
    The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS total score.
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 1
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    39
    41
    Units: units on a scale
        least squares mean (standard error)
    -4.81 ( 0.77 )
    -4.20 ( 0.80 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in MADRS total score at Day 3

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    End point title
    		 Change from Baseline in MADRS total score at Day 3
    End point description
    The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS total score.
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 3
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    39
    41
    Units: units on a scale
        least squares mean (standard error)
    -7.47 ( 1.01 )
    -7.81 ( 1.03 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in MADRS total score at Day 7

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    End point title
    		 Change from Baseline in MADRS total score at Day 7
    End point description
    The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS total score.
    End point type
    Secondary
    End point timeframe
    Change from Baseline in MADRS total score at Day 7
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    38
    41
    Units: units on a scale
        least squares mean (standard error)
    -9.38 ( 1.26 )
    -10.63 ( 1.26 )
    No statistical analyses for this end point

    Secondary: Response (defined as a >= 50% decrease in MADRS total score from Baseline) on Day 1

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    End point title
    		 Response (defined as a >= 50% decrease in MADRS total score from Baseline) on Day 1
    End point description
    The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS total score.
    End point type
    Secondary
    End point timeframe
    From baseline to Day 1
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    39
    41
    Units: patients
    1
    0
    No statistical analyses for this end point

    Secondary: Response (defined as a >= 50% decrease in MADRS total score from Baseline) on Day 3

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    End point title
    		 Response (defined as a >= 50% decrease in MADRS total score from Baseline) on Day 3
    End point description
    The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS total score.
    End point type
    Secondary
    End point timeframe
    From baseline to Day 3
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    39
    41
    Units: patients
    3
    3
    No statistical analyses for this end point

    Secondary: Clinical Global Impression-Global Improvement (CGI-I) score relative to Baseline at Day 1

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    End point title
    		 Clinical Global Impression-Global Improvement (CGI-I) score relative to Baseline at Day 1
    End point description
    The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.
    End point type
    Secondary
    End point timeframe
    From baseline to Day 1
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    39
    41
    Units: units on a scale
        least squares mean (standard error)
    3.34 ( 0.13 )
    3.39 ( 0.14 )
    No statistical analyses for this end point

    Secondary: Clinical Global Impression-Global Improvement (CGI-I) score relative to Baseline at Day 3

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    End point title
    		 Clinical Global Impression-Global Improvement (CGI-I) score relative to Baseline at Day 3
    End point description
    The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.
    End point type
    Secondary
    End point timeframe
    From baseline to Day 3
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    39
    41
    Units: units on a scale
        least squares mean (standard error)
    3.08 ( 0.14 )
    3.12 ( 0.14 )
    No statistical analyses for this end point

    Secondary: Clinical Global Impression-Global Improvement (CGI-I) score relative to Baseline at Day 7

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    End point title
    		 Clinical Global Impression-Global Improvement (CGI-I) score relative to Baseline at Day 7
    End point description
    The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.
    End point type
    Secondary
    End point timeframe
    From baseline to Day 7
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    38
    41
    Units: units on a scale
        least squares mean (standard error)
    2.84 ( 0.16 )
    2.90 ( 0.16 )
    No statistical analyses for this end point

    Secondary: CGI-I response (defined as CGI-I score <= 2) on Day 1

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    End point title
    		 CGI-I response (defined as CGI-I score <= 2) on Day 1
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to Day 1
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    39
    41
    Units: patients
    3
    5
    No statistical analyses for this end point

    Secondary: CGI-I response (defined as CGI-I score <= 2) on Day 3

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    End point title
    		 CGI-I response (defined as CGI-I score <= 2) on Day 3
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to Day 3
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    39
    41
    Units: patients
    6
    9
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Global Impression-Severity of Illness (CGI-S) score at Day 1

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    End point title
    		 Change from Baseline in Clinical Global Impression-Severity of Illness (CGI-S) score at Day 1
    End point description
    The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
    End point type
    Secondary
    End point timeframe
    From baseline to Day 1
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    39
    41
    Units: units on a scale
        least squares mean (standard error)
    -0.28 ( 0.09 )
    -0.33 ( 0.09 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Global Impression-Severity of Illness (CGI-S) score at Day 3

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    End point title
    		 Change from Baseline in Clinical Global Impression-Severity of Illness (CGI-S) score at Day 3
    End point description
    The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
    End point type
    Secondary
    End point timeframe
    From baseline to Day 3
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    39
    41
    Units: units on a scale
        least squares mean (standard error)
    -0.66 ( 0.12 )
    -0.67 ( 0.12 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Global Impression-Severity of Illness (CGI-S) score at Day 7

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    End point title
    		 Change from Baseline in Clinical Global Impression-Severity of Illness (CGI-S) score at Day 7
    End point description
    The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
    End point type
    Secondary
    End point timeframe
    From baseline to Day 7
    End point values
    		 Vortioxetine Placebo
    Number of subjects analysed
    38
    41
    Units: units on a scale
        least squares mean (standard error)
    -0.90 ( 0.15 )
    -1.01 ( 0.15 )
    No statistical analyses for this end point

    Secondary: Cav Day 0 (bed time)

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    End point title
    		 Cav Day 0 (bed time) [1]
    End point description
    average plasma concentration during a steady-state day
    End point type
    Secondary
    End point timeframe
    Day 0
    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: No data available
    End point values
    		 Vortioxetine
    Number of subjects analysed
    39
    Units: ng/mL
        arithmetic mean (standard deviation)
    9.51 ( 2.83 )
    No statistical analyses for this end point

    Secondary: Cav Day 0 (2hrs post-IV)

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    End point title
    		 Cav Day 0 (2hrs post-IV) [2]
    End point description
    Average plasma concentration during a steady-state day
    End point type
    Secondary
    End point timeframe
    Day 0
    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: No data available
    End point values
    		 Vortioxetine
    Number of subjects analysed
    38
    Units: ng/mL
        arithmetic mean (standard deviation)
    13.91 ( 13.43 )
    No statistical analyses for this end point

    Secondary: Cav Day 1

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    End point title
    		 Cav Day 1 [3]
    End point description
    average plasma concentration during a steady-state day
    End point type
    Secondary
    End point timeframe
    Day 1
    Notes
    [3] - 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: No data available
    End point values
    		 Vortioxetine
    Number of subjects analysed
    38
    Units: ng/mL
        arithmetic mean (standard deviation)
    9.93 ( 2.78 )
    No statistical analyses for this end point

    Secondary: Cav Day 7

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    End point title
    		 Cav Day 7 [4]
    End point description
    average plasma concentration during a steady-state day
    End point type
    Secondary
    End point timeframe
    Day 7
    Notes
    [4] - 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: No data available
    End point values
    		 Vortioxetine
    Number of subjects analysed
    38
    Units: ng/mL
        arithmetic mean (standard deviation)
    11.93 ( 5.95 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    35 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    DBT: Vortioxetine IV 25 mg + Vortioxetine Oral 10 mg
    Reporting group description
    		 -

    Reporting group title
    DBT: Placebo IV + Placebo Oral
    Reporting group description
    		 -

    Serious adverse events
    		 DBT: Vortioxetine IV 25 mg + Vortioxetine Oral 10 mg DBT: Placebo IV + Placebo Oral
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Major depression
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DBT: Vortioxetine IV 25 mg + Vortioxetine Oral 10 mg DBT: Placebo IV + Placebo Oral
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 39 (53.85%)
    15 / 41 (36.59%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 41 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 39 (10.26%)
    3 / 41 (7.32%)
         occurrences all number
    5
    3
    Headache
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 41 (2.44%)
         occurrences all number
    2
    1
    Sedation
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 41 (7.32%)
         occurrences all number
    1
    4
    Somnolence
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 41 (9.76%)
         occurrences all number
    1
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 41 (2.44%)
         occurrences all number
    2
    1
    Nausea
         subjects affected / exposed
    5 / 39 (12.82%)
    7 / 41 (17.07%)
         occurrences all number
    7
    7
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    4 / 39 (10.26%)
    0 / 41 (0.00%)
         occurrences all number
    4
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 41 (0.00%)
         occurrences all number
    2
    0
    Insomnia
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 41 (2.44%)
         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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    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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