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    Clinical Trial Results:
    Effects of Vortioxetine in Mild Cognitive Impairment measured by Functional Magnetic Resonance Imaging

    Summary
    EudraCT number
    		 2019-001836-69
    Trial protocol
    		 AT  
    Global end of trial date
    04 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jan 2026
    First version publication date
    30 Jan 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Vort-MCI_001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria, 1090
    Public contact
    Department of Psychiatry, Medical University of Vienna, +43 14040035470,
    Scientific contact
    Department of Psychiatry, Medical University of Vienna, +43 14040035470,
    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
    04 Dec 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Dec 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To measure the effect of vortioxetine 10mg or 20mg on brain functional connectivity (FC) assessed by functional magnetic resonance imaging (fMRI) and neuropsychological parameters.
    Protection of trial subjects
    Vivienne Matev 13.01.2026 10:59 • Primary Objective: To measure the effect of vortioxetine (10mg or 20mg) versus placebo on brain functional connectivity (FC) assessed by functional magnetic resonance imaging (fMRI). Secondary Objective: To measure the effect of the study drug on neuropsychological parameters.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2021
    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
    Austria: 47
    Worldwide total number of subjects
    47
    EEA total number of subjects
    47
    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)
    5
    From 65 to 84 years
    42
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Vivienne Matev 13.01.2026 11:01 • Subjects were recruited at the memory clinic of the Department of Psychiatry and Psychotherapy at the Medical University of Vienna, as well as through advertisements in local newspapers.

    Pre-assignment
    Screening details
    		 Study subjects were 54 to 80 years of age (mean age 70 ± 6.86, 31 male, 16 female) and met criteria for MCI following the criteria stipulated by the National Institute on Aging – Alzheimer’s Association (NIA-AA) workgroups on diagnostic guidelines for Alzheimer’s disease (Albert et al, 2011).

    Period 1
    Period 1 title
    Medication (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Tablets will have to be taken orally once a day (q. d.) in the morning for a total duration of 12 weeks.
    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
    Tablets will have to be taken orally once a day (q. d.) in the morning for a total duration of 12 weeks.

    Arm title
    		 Vortioxetin 10mg
    Arm description
    		 . Vortioxetine will be started at a daily dose of 5mg for 3 days. Tablets will have to be taken orally once a day (q. d.) in the morning for a total duration of 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioexetin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Ocular use
    Dosage and administration details
    Vortioxetine will be started at a daily dose of 5mg for 3 days. 10mg tablets will have to be taken orally once a day (q. d.) in the morning for a total duration of 12 weeks.

    Arm title
    		 Vortioxetin 20mg
    Arm description
    		 20 mg tablets of vortioxetine will have to be taken orally once a day (q. d.) in the morning for a total duration of 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioexetin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Ocular use
    Dosage and administration details
    Vortioxetine will be started at a daily dose of 5mg for 3 days. Patients in the vortioxetine 20mg group will receive 10mg for further 3 days before dose increase to 20mg. 20mg tablets will have to be taken orally once a day (q. d.) in the morning for a total duration of 12 weeks.

    Number of subjects in period 1
    		Placebo Vortioxetin 10mg Vortioxetin 20mg
    Started
    15
    16
    16
    Completed
    15
    16
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Tablets will have to be taken orally once a day (q. d.) in the morning for a total duration of 12 weeks.

    Reporting group title
    Vortioxetin 10mg
    Reporting group description
    		 . Vortioxetine will be started at a daily dose of 5mg for 3 days. Tablets will have to be taken orally once a day (q. d.) in the morning for a total duration of 12 weeks

    Reporting group title
    Vortioxetin 20mg
    Reporting group description
    		 20 mg tablets of vortioxetine will have to be taken orally once a day (q. d.) in the morning for a total duration of 12 weeks.

    Reporting group values
    		 Placebo Vortioxetin 10mg Vortioxetin 20mg Total
    Number of subjects
    		 15 16 16 47
    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)
    		 1 3 1 5
        From 65-84 years
    		 14 13 15 42
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 4 5 7 16
        Male
    		 11 11 9 31

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Tablets will have to be taken orally once a day (q. d.) in the morning for a total duration of 12 weeks.

    Reporting group title
    Vortioxetin 10mg
    Reporting group description
    		 . Vortioxetine will be started at a daily dose of 5mg for 3 days. Tablets will have to be taken orally once a day (q. d.) in the morning for a total duration of 12 weeks

    Reporting group title
    Vortioxetin 20mg
    Reporting group description
    		 20 mg tablets of vortioxetine will have to be taken orally once a day (q. d.) in the morning for a total duration of 12 weeks.

    Subject analysis set title
    Score change from baseline o
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Statistical analysis of neuropsychological data was performed using the R Project for Statistical Computing (https://www.r-project.org/). Changes in cognitive performance, measured by total test scores, were analyzed using linear mixed models (LMM), with time as a within-subjects factor and treatment group (vortioxetine 10mg, 20mg, or placebo) as a between-subjects factor, with the significance level set at α = 0.05. Post-hoc Tukey tests were computed to account for multiple comparisons.

    Primary: Score change from baseline on the verbal learning test (VLMT)

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    End point title
    		 Score change from baseline on the verbal learning test (VLMT)
    End point description
    End point type
    Primary
    End point timeframe
    baseline, week 4, week 8, week 12
    End point values
    		 Placebo Vortioxetin 10mg Vortioxetin 20mg
    Number of subjects analysed
    15
    16
    16
    Units: test score
        arithmetic mean (standard deviation)
    3.4 ( 6.06 )
    5.31 ( 7.12 )
    5.44 ( 6.29 )
    Statistical analysis title
    		 Score change
    Statistical analysis description
    Statistical analysis of neuropsychological data was performed using the R Project for Statistical Computing (https://www.r-project.org/). Changes in cognitive performance, measured by total test scores, were analyzed using linear mixed models (LMM), with time as a within-subjects factor and treatment group (vortioxetine 10mg, 20mg, or placebo) as a between-subjects factor, with the significance level set at α = 0.05. Post-hoc Tukey tests were computed to account for multiple comparisons.
    Comparison groups
    Placebo v Vortioxetin 10mg v Vortioxetin 20mg
    Number of subjects included in analysis
    47
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    at Week 1,2,4,8,12
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Tablets will have to be taken orally once a day (q. d.) in the morning for a total duration of 12 weeks.

    Reporting group title
    Vortioxetin 10mg
    Reporting group description
    		 . Vortioxetine will be started at a daily dose of 5mg for 3 days. Tablets will have to be taken orally once a day (q. d.) in the morning for a total duration of 12 weeks

    Reporting group title
    Vortioxetin 20mg
    Reporting group description
    		 20 mg tablets of vortioxetine will have to be taken orally once a day (q. d.) in the morning for a total duration of 12 weeks.

    Serious adverse events
    		 Placebo Vortioxetin 10mg Vortioxetin 20mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Vortioxetin 10mg Vortioxetin 20mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    4 / 16 (25.00%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    4 / 16 (25.00%)
         occurrences all number
    0
    1
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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