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    Clinical Trial Results:
    The effect of antidepressant therapy on quality of life, physical and menthal health and cortisole metabolism in PCOS.

    Summary
    EudraCT number
    		 2010-022319-20
    Trial protocol
    		 DK  
    Global end of trial date
    30 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Nov 2020
    First version publication date
    30 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    24638418
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    kløvervænget 6, Odense, Denmark, 5000
    Public contact
    Department of Endocrinology, Odense University Hospital, department of Endocrinology, +45 65412502,
    Scientific contact
    Marianne Andersen, Odense University Hospital, department of Endocrinology, +45 65412502, msa@rsyd.dk
    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
    29 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1)To investigate if treatment with cipralex will diminish the adrenal activity in PCOS patients versus placebo. 2)To investigate if quality of life, physical and menthal health improves, in PCOS patient on cipralex treatment versus placebo.
    Protection of trial subjects
    National authorities in Denmark
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 42
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    42
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 42 overweight premenopausal women with PCOS and no clinical depression

    Pre-assignment
    Screening details
    		 Invited from PCOS clinic

    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, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    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
    1 tablet/day

    Arm title
    		 SSRI
    Arm description
    		 escitalopram
    Arm type
    		 Active comparator

    Investigational medicinal product name
    escitalopram
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    escitalopram 20 mg/day

    Number of subjects in period 1
    		Placebo SSRI
    Started
    21
    21
    Completed
    19
    20
    Not completed
    2
    1
         Consent withdrawn by subject
    2
    -
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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

    Reporting group title
    SSRI
    Reporting group description
    		 escitalopram

    Reporting group values
    		 Placebo SSRI Total
    Number of subjects
    		 21 21 42
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    age
    Units: years
        geometric mean (standard deviation)
    		 31 ( 6 ) 33 ( 7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 21 21 42
        Male
    		 0 0 0

    End points

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

    Reporting group title
    SSRI
    Reporting group description
    		 escitalopram

    Primary: BMI

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    End point title
    		 BMI
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Placebo SSRI
    Number of subjects analysed
    19
    20
    Units: kg/m2
        geometric mean (standard deviation)
    35.7 ( 6.1 )
    35.9 ( 6.6 )
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Placebo v SSRI
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    3 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 -

    Reporting group title
    SSRÍ
    Reporting group description
    		 -

    Serious adverse events
    		 placebo SSRÍ
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 21 (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 SSRÍ
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    Gastrointestinal disorders
    nausea
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29472241
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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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