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    Clinical Trial Results:
    The effect of agomelatine on CLOCK gene expression in patients with major depressive disorder and healthy controls: an exploratory study.

    Summary
    EudraCT number
    		 2010-021044-17
    Trial protocol
    		 AT  
    Global end of trial date
    04 Nov 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLOCK_depression
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Department of Clinical Pharmacology, Department of Clinical Pharmacology, 0043 14040029810,
    Scientific contact
    Department of Clinical Pharmacology, Department of Clinical Pharmacology, 0043 14040029810,
    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 Dec 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Nov 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2011
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Rhythmic 24hour mRNA expression of CLOCK genes, differences in transcript levels of CLOCK genes, differences in the genome-wide gene expression, assessed in mRNA from peripheral blood leucocytes.
    Protection of trial subjects
    Subjects were during the trial under the supervision of a physician or an experienced nurse.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Sep 2010
    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: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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)
    9
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited by use of the data base of the Dep. of Clinical Pharmacology, Medical University of Vienna.

    Pre-assignment
    Screening details
    		 Check of the in- and exclusion criteria, physical examination, vital signs, laboratory assessment and ECG recording

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Study group A healthy subjects
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Agomelatine (VALDOXAN 25 mg – Filmtabletten)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Intake of VALDOXAN 25 mg coated tablets, once a day at 11:00 PM ± 1 hour for 14 consecutive days. is foreseen

    Arm title
    		 Study group B Patients with MDD
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Agomelatine (VALDOXAN 25 mg – Filmtabletten)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Intake of VALDOXAN 25 mg coated tablets, once a day at 11:00 PM ± 1 hour for 14 consecutive days. is foreseen

    Number of subjects in period 1
    		Study group A healthy subjects Study group B Patients with MDD
    Started
    5
    4
    Completed
    4
    4
    Not completed
    1
    0
         Physician decision
    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
    		 9 9
    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)
    		 9 9
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    Study group A healthy subjects
    Reporting group description
    		 -

    Reporting group title
    Study group B Patients with MDD
    Reporting group description
    		 -

    Primary: Differences in leucocyte CLOCK gene expression in depressed patients before and after agomelatine treatment

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    End point title
    		 Differences in leucocyte CLOCK gene expression in depressed patients before and after agomelatine treatment
    End point description
    End point type
    Primary
    End point timeframe
    14 days
    End point values
    		 Study group A healthy subjects Study group B Patients with MDD
    Number of subjects analysed
    4
    4
    Units: other
    4
    4
    Statistical analysis title
    		 Statistics to end point
    Comparison groups
    Study group B Patients with MDD v Study group A healthy subjects
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Differences in leucocyte CLOCK gene expression in healthy subjects before and after agomelatine treatment

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    End point title
    		 Differences in leucocyte CLOCK gene expression in healthy subjects before and after agomelatine treatment
    End point description
    End point type
    Primary
    End point timeframe
    14 days
    End point values
    		 Study group A healthy subjects Study group B Patients with MDD
    Number of subjects analysed
    4
    4
    Units: other
    4
    4
    Statistical analysis title
    		 Statistics to end point
    Comparison groups
    Study group A healthy subjects v Study group B Patients with MDD
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Comparision between lecocyte CLOCK gene expression between healthy subjects and patients at baseline and after agomelatine treatment

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    End point title
    		 Comparision between lecocyte CLOCK gene expression between healthy subjects and patients at baseline and after agomelatine treatment
    End point description
    End point type
    Primary
    End point timeframe
    14 days
    End point values
    		 Study group A healthy subjects Study group B Patients with MDD
    Number of subjects analysed
    4
    4
    Units: other
    4
    4
    Statistical analysis title
    		 End point statistic
    Comparison groups
    Study group A healthy subjects v Study group B Patients with MDD
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    20.10.2010-04.11.2011
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Adverse events overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse events overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adverse events overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 9 (77.78%)
    Vascular disorders
    Angina
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Migraine
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Fatigue during exercise
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    5
    Tiredness
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Pain (lower abdomen)
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Menstrual disorder
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Gastrointestinal disorders
    sore throat
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Psychiatric disorders
    Dysphoria
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    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? Yes
    Date
    Interruption
    Restart date
    04 Nov 2011
    Unsuccessful recruitment
    -

    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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