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    Clinical Trial Results:
    Cytokines and Inflammatory Marker during Therapy in Major Depression with Celecoxib

    Summary
    EudraCT number
    		 2009-011990-34
    Trial protocol
    		 DE   AT  
    Global end of trial date
    18 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2021
    First version publication date
    19 Feb 2021
    Other versions
    Summary report(s)
    		 study and results summary for authority use only

    Trial information

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    Trial identification
    Sponsor protocol code
    AFX02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Clinic for Psychiatry and Psychotherapy of the Ludwig Maximilian University, AöR
    Sponsor organisation address
    Nussbaumstrasse, Munich, Germany,
    Public contact
    Studienzentrum Psychiatrie, Clinic for Psychiatry and Psychotherapy of the Ludwig Maximilian University, 0049 89440052769,
    Scientific contact
    Studienzentrum Psychiatrie, Clinic for Psychiatry and Psychotherapy of the Ludwig Maximilian University, 0049 89440052769,
    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
    06 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To prove or disapprove the hypothesis that an initially raised monocyte COX-2 (PGE-2) expression, the RNA monocyte signature expression, and the serum tryptophan/kynurenine ratio identify a subgroup of patients clinically responding better to add-on COX-2 inhibitor treatment in terms of improvement of the HamD-17 score.
    Protection of trial subjects
    Before first Treatment with study medication patients undergo consultation by a cardiologist. In case of urgent safety issues throughout the trial, the sponsor can make changes to the protocol without approval.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 May 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
    Germany: 57
    Worldwide total number of subjects
    57
    EEA total number of subjects
    57
    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)
    57
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients enter a 3-day wash-out period prior to the start of study medication. 65 patients were assessed for eligibility.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 sertraline plus placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    sertraline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50-100mg daily

    Arm title
    		 sertraline plus celecoxib
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Celecoxib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    200mg twice daily

    Number of subjects in period 1 [1]
    		sertraline plus placebo sertraline plus celecoxib
    Started
    24
    27
    Completed
    23
    20
    Not completed
    1
    7
         Adverse event, non-fatal
    -
    1
         misdiagnosed
    -
    1
         Lost to follow-up
    -
    2
         Protocol deviation
    1
    1
         Lack of efficacy
    -
    2
    Notes
    [1] - 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: 57 patients were enrolled in the study. However, 1 Patient developed an exclusion criteria before randomization and 5 patients withdrew the informed consent before randomization. Therefore, 51 patients entered the treatment phase and study assessments.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    sertraline plus placebo
    Reporting group description
    		 -

    Reporting group title
    sertraline plus celecoxib
    Reporting group description
    		 -

    Reporting group values
    		 sertraline plus placebo sertraline plus celecoxib Total
    Number of subjects
    		 24 27 51
    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
    Units: years
        arithmetic mean (standard deviation)
    		 39.29 ( 10.77 ) 41.41 ( 11.96 ) -
    Gender categorical
    Units: Subjects
        Female
    		 12 13 25
        Male
    		 12 14 26

    End points

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    End points reporting groups
    Reporting group title
    sertraline plus placebo
    Reporting group description
    		 -

    Reporting group title
    sertraline plus celecoxib
    Reporting group description
    		 -

    Primary: MADRS score decrease

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    End point title
    		 MADRS score decrease
    End point description
    End point type
    Primary
    End point timeframe
    week 6
    End point values
    		 sertraline plus placebo sertraline plus celecoxib
    Number of subjects analysed
    23
    19
    Units: number of subjects
        responder
    16
    11
        non-responder
    7
    8
    Statistical analysis title
    		 Difference of response rates
    Comparison groups
    sertraline plus placebo v sertraline plus celecoxib
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were assessed at each study visit: baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 10.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 GCP
    Dictionary version
    2
    Reporting groups
    Reporting group title
    sertraline plus placebo
    Reporting group description
    		 -

    Reporting group title
    sertraline plus celecoxib
    Reporting group description
    		 -

    Serious adverse events
    		 sertraline plus placebo sertraline plus celecoxib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (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
    		 sertraline plus placebo sertraline plus celecoxib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 23 (95.65%)
    11 / 27 (40.74%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 23 (13.04%)
    2 / 27 (7.41%)
         occurrences all number
    3
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 23 (21.74%)
    3 / 27 (11.11%)
         occurrences all number
    5
    3
    Nausea
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 27 (3.70%)
         occurrences all number
    2
    1
    Nausea + dizziness
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 27 (3.70%)
         occurrences all number
    2
    1
    Reproductive system and breast disorders
    Ejaculation disorder
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    3 / 23 (13.04%)
    1 / 27 (3.70%)
         occurrences all number
    3
    1
    Endocrine disorders
    increased sweating
         subjects affected / exposed
    3 / 23 (13.04%)
    3 / 27 (11.11%)
         occurrences all number
    3
    3
    Infections and infestations
    influenzal infection
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0

    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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