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    Clinical Trial Results:
    Interventional, randomised, double-blind, parallel-group study of the efficacy and safety of initial administration of 17 mg vortioxetine intravenously with 10 mg/day vortioxetine orally in patients with Major Depressive Disorder

    Summary
    EudraCT number
    		 2015-005081-30
    Trial protocol
    		 EE   LT   FI   SK  
    Global end of trial date
    27 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 May 2018
    First version publication date
    12 May 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    16903A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02919501
    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 36 3013 11, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    Lundbeck Clinical Trials, H. Lundbeck A/S, +45 36 3013 11, 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
    27 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the early onset of efficacy of vortioxetine 17 mg IV and vortioxetine 10 mg/day oral dose regimen versus placebo IV and vortioxetine 10 mg/day oral dose regimen on depressive symptoms
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH Good Clinical Practice (1996).
    Background therapy
    		 The study consisted of a: • Screening Period – 2 to 14-day period from screening to randomisation • Treatment Period – 15-day double-blind treatment period with one initial IV administration of 17mg vortioxetine or placebo and daily oral treatment with vortioxetine 10mg. • Safety Follow-up Period – 4-week period after end of treatment or after withdrawal from the study
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Sep 2016
    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
    Estonia: 27
    Country: Number of subjects enrolled
    Finland: 28
    Worldwide total number of subjects
    55
    EEA total number of subjects
    55
    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)
    51
    From 65 to 84 years
    4
    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
    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
    		 Placebo IV + vortioxetine oral
    Arm description
    		 placebo to vortioxetine IV and oral vortioxetine
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Saline: isotonic sodium chloride, administered, over 2 hours as single dose

    Investigational medicinal product name
    Vortioxetine 10 mg/day
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Vortioxetine (tablet): 10 mg, tablets, oral administration once daily for 15 days (open labelled)

    Arm title
    		 Vortioxetine IV + vortioxetine oral
    Arm description
    		 vortioxetine IV and oral vortioxetine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioxetine IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Drug: vortioxetine (IV): 17 mg, solution for infusion, administered, over 2 hours as single dose

    Investigational medicinal product name
    Vortioxetine 10 mg/day
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Vortioxetine (tablet): 10 mg, tablets, oral administration once daily for 15 days (open labelled)

    Number of subjects in period 1
    		Placebo IV + vortioxetine oral Vortioxetine IV + vortioxetine oral
    Started
    28
    27
    Completed
    28
    26
    Not completed
    0
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 55 55
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 51 51
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 43 43
        Male
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    Placebo IV + vortioxetine oral
    Reporting group description
    		 placebo to vortioxetine IV and oral vortioxetine

    Reporting group title
    Vortioxetine IV + vortioxetine oral
    Reporting group description
    		 vortioxetine IV and oral vortioxetine

    Primary: Change from baseline to week 1 in MADRS total score

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    End point title
    		 Change from baseline to week 1 in MADRS total score
    End point description
    Change from baseline to week 1 in MADRS total score. 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. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
    End point type
    Primary
    End point timeframe
    From baseline to week 1 (Day 7)
    End point values
    		 Placebo IV + vortioxetine oral Vortioxetine IV + vortioxetine oral
    Number of subjects analysed
    28
    27
    Units: units on a scale
        least squares mean (standard error)
    -13.8 ( 1.8 )
    -14.0 ( 1.9 )
    Statistical analysis title
    		 Superiority
    Comparison groups
    Placebo IV + vortioxetine oral v Vortioxetine IV + vortioxetine oral
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9197
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 4.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.3

    Secondary: Change From baseline to Day 14 in MADRS Total Score

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    End point title
    		 Change From baseline to Day 14 in MADRS Total Score
    End point description
    Change From baseline to Day 14 in MADRS Total Score. 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. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
    End point type
    Secondary
    End point timeframe
    from baseline to Day 14
    End point values
    		 Placebo IV + vortioxetine oral Vortioxetine IV + vortioxetine oral
    Number of subjects analysed
    28
    27
    Units: units on a scale
        least squares mean (standard error)
    -18.2 ( 1.7 )
    -17.1 ( 1.8 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Day 3 in MADRS total score

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    End point title
    		 Change from baseline to Day 3 in MADRS total score
    End point description
    Change from baseline to Day 3 in MADRS total score. 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. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
    End point type
    Secondary
    End point timeframe
    from baseline to Day 3
    End point values
    		 Placebo IV + vortioxetine oral Vortioxetine IV + vortioxetine oral
    Number of subjects analysed
    28
    27
    Units: units on a scale
        least squares mean (standard error)
    -10.7 ( 1.6 )
    -12.3 ( 1.7 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Day 1 in MADRS total score

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    End point title
    		 Change from baseline to Day 1 in MADRS total score
    End point description
    Change from baseline to Day 1 in MADRS total score. 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. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
    End point type
    Secondary
    End point timeframe
    from baseline to Day 1
    End point values
    		 Placebo IV + vortioxetine oral Vortioxetine IV + vortioxetine oral
    Number of subjects analysed
    28
    27
    Units: unita on a scale
        least squares mean (standard error)
    -5.9 ( 1.2 )
    -7.2 ( 1.3 )
    No statistical analyses for this end point

    Secondary: Response at Day 7

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    End point title
    		 Response at Day 7
    End point description
    Response (defined as a ≥50% decrease in MADRS total score from baseline) at Day 7. 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. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
    End point type
    Secondary
    End point timeframe
    At Day 7
    End point values
    		 Placebo IV + vortioxetine oral Vortioxetine IV + vortioxetine oral
    Number of subjects analysed
    28
    27
    Units: patients
    8
    11
    No statistical analyses for this end point

    Secondary: Remission at Day 7

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    End point title
    		 Remission at Day 7
    End point description
    Remission (defined as a MADRS total score ≤10) at Day 7. 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. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
    End point type
    Secondary
    End point timeframe
    At Day 7
    End point values
    		 Placebo IV + vortioxetine oral Vortioxetine IV + vortioxetine oral
    Number of subjects analysed
    28
    27
    Units: patients
    3
    4
    No statistical analyses for this end point

    Secondary: Change from baseline to Day 7 in HADS depression subscale score

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    End point title
    		 Change from baseline to Day 7 in HADS depression subscale score
    End point description
    Change from baseline to Day 7 in Hospital Anxiety and Depression subscale Score. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
    End point type
    Secondary
    End point timeframe
    from baseline to Day 7
    End point values
    		 Placebo IV + vortioxetine oral Vortioxetine IV + vortioxetine oral
    Number of subjects analysed
    28
    27
    Units: units on a scale
        least squares mean (standard deviation)
    -3.3 ( 0.8 )
    -3.4 ( 0.8 )
    No statistical analyses for this end point

    Secondary: CGI-I score at Day 7

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    End point title
    		 CGI-I score at Day 7
    End point description
    The Clinical Global Impression (CGI-I) at Day 7 - global improvement 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).
    End point type
    Secondary
    End point timeframe
    at Day 7
    End point values
    		 Placebo IV + vortioxetine oral Vortioxetine IV + vortioxetine oral
    Number of subjects analysed
    28
    26
    Units: units on a scale
        least squares mean (standard error)
    2.6 ( 0.2 )
    2.5 ( 0.2 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Day 7 in CGI-S score

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    End point title
    		 Change from baseline to Day 7 in CGI-S score
    End point description
    Change from baseline to Day 7 in Clinical Global Impression severity of illness (CGI-S) score. This scale 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
    		 Placebo IV + vortioxetine oral Vortioxetine IV + vortioxetine oral
    Number of subjects analysed
    28
    27
    Units: units on a scale
        least squares mean (standard error)
    -1.4 ( 0.3 )
    -1.4 ( 0.3 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Day 7 in HADS anxiety subscale score

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    End point title
    		 Change from baseline to Day 7 in HADS anxiety subscale score
    End point description
    Change from baseline to Day 7 in Hospital Anxiety and Depression subscale Score. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
    End point type
    Secondary
    End point timeframe
    From baseline to Day 7
    End point values
    		 Placebo IV + vortioxetine oral Vortioxetine IV + vortioxetine oral
    Number of subjects analysed
    28
    27
    Units: units on a scale
        least squares mean (standard error)
    -3.9 ( 0.8 )
    -4.7 ( 0.9 )
    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
    19.0
    Reporting groups
    Reporting group title
    Placebo IV + vortioxetine oral
    Reporting group description
    		 Placebo IV and vortioxetine oral

    Reporting group title
    Vortioxetine IV + vortioxetine oral
    Reporting group description
    		 Vortioxetine IV and vortioxetine oral

    Serious adverse events
    		 Placebo IV + vortioxetine oral Vortioxetine IV + vortioxetine oral
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo IV + vortioxetine oral Vortioxetine IV + vortioxetine oral
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 28 (60.71%)
    20 / 27 (74.07%)
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 28 (14.29%)
    4 / 27 (14.81%)
         occurrences all number
    5
    4
    Somnolence
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 28 (14.29%)
    2 / 27 (7.41%)
         occurrences all number
    4
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 27 (11.11%)
         occurrences all number
    1
    3
    Nausea
         subjects affected / exposed
    9 / 28 (32.14%)
    13 / 27 (48.15%)
         occurrences all number
    9
    14
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed [1]
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 27 (11.11%)
         occurrences all number
    1
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 28 (14.29%)
    1 / 27 (3.70%)
         occurrences all number
    4
    1
    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: This Non Serious Adverse Event is only applicable for male subjects.

    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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