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    The EU Clinical Trials Register currently displays   37527   clinical trials with a EudraCT protocol, of which   6154   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2009-011990-34
    Sponsor's Protocol Code Number:AFX02
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-16
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2009-011990-34
    A.3Full title of the trial
    Cytokines and Inflammatory Marker during Therapy in Major Depression with Celecoxib
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberAFX02
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKlinik für Psychiatrie und Psychotherapie der Ludwig Maximilian Universität München
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D. name Celebrex
    D. of the Marketing Authorisation holderPharmacia Limited
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCelecoxib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major Depression
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    1) Changes from baseline to endpoint (week 6) in HamD-17 score.
    2) Changes from baseline to endpoint (week 6) in Montgomery Asberg Depression Rating Scale (MADRS) score.
    3) To prove or disapprove the hypothesis that a rapid decline of initially raised RNA monocyte signature or the serum tryptophan/kynurenine ratio during COX-2 inhibitor treatment identifies a subgroup of patients clinically responding better to add-on COX-2 inhibitor treatment in terms of improvement of the HamD-17 score.
    4) In an exploratory design, serum levels of CRP, IL-1, IL-1Ra, IL-6, IL-17, TNF-α, TNF-R1, TNF-R2, MIF, TGF-ß, and neuroactive kynurenine metabolites will be followed up during therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Major depression diagnosed by psychiatrist
    2) DSM IV TR: 296.2x single depressive episode or 296.3x recurrent depressive episode
    3) HamD-17 score ≥ 22
    4) Informed consent
    5) Age between 18 and 60 years
    E.4Principal exclusion criteria
    1) Psychotic depression or bipolar disorder, drug or alcohol addiction, schizoaffective disorders, schizophrenia. Other disorders (e.g. obsessive compulsive disorder, anxiety disorder, personality disorder) in case the symptoms predominate the clinical picture.
    2) Unsuccessful treatment with more than 2 antidepressant medications (at therapeutically adequate doses and duration) during current episode.
    3) Concomitant use of psychotropic drugs, including mood stabilizers, besides defined co-medication.
    4) Immediate risk for suicidal behavior (3 on HamD-17 rating scale or 5 on MAD Rating Scale).
    5) Women who are pregnant, breast feeding or planning to become pregnant during the course of study.
    6) Women who are not post-menopausal (no natural menopause established in retrospect after 12 consecutive months of amenorrhea without hormone replacement therapy during the last 5 months), surgically sterilized or using a highly effective method of contraception (an implanted or injected hormonal contraceptive, some intrauterine contraceptive devices (IUDs) containing hormones, sexual abstinence, or have a vasectomized partner). Females using combined oral contraceptives should use a different or additional highly effective method of contraception as listed above.
    7) Any history of cardiovascular disease (e.g. angina, heart attack, stroke, congestive heart failure), uncontrolled high blood pressure, documented peripheral arterial insufficiency and symptomatic, clinically significant claudication, a history of peripheral arterial embolism or cerebrovascular disease.
    8) Patients at risk of QT/QTc interval prolongation (QTc> 450 ms, family history of long QT syndrome or use of medication prolonging QT/QTc interval).
    9) History of coronary heart disease (CHD) or any other heart disease.
    10) Serum NTproBNP ≥ 125 pg/mL indicating (sub-) clinical heart failure.
    11) History of upper or lower gastrointestinal (GI) ulceration, perforation and/or obstruction.
    12) History of upper or lower GI bleeding within the previous year.
    13) History of inflammatory bowel disease.
    14) Undergoing cancer chemotherapy.
    15) Known HIV infection or clinically manifest Acquired Immune Deficiency Syndrome (AIDS), diabetes, asthma, COPD, Parkinson’s or Alzheimer’s disease, or any other serious condition likely to interfere with the conduct of the trial.
    16) Clinically relevant hepatic or renal impairment (serum albumin < 25 g/L or Child-Pugh > 10 or renal GFR < 30 mL/min), or other clinically significant physical findings or clinically significant laboratory results at screening or baseline, as determined by the investigator.
    17) History of allergy to sertraline, celecoxib, sulfonamides or closely related compounds, or excipients.
    18) History of hypersensitivity or intolerance to pain medications.
    19) Use of pain medication, such as a COX-2 inhibitor, NSAID (non-steroidal anti-inflammatory drug, including aspirin) or acetaminophen (syn. paracetamol) within 72 hours prior to study entry (24 hours for short-acting drugs such as aspirin or acetaminophen).
    20) Patients currently taking warfarin.
    21) Participation in a study of an investigational drug or device concomitantly or within 30 days prior to this study.
    22) Patients thought to be unreliable or incapable of complying with the requirements of the protocol.
    23) Treatment with monoamino oxidase inhibitors during the last 14 days or treatment with fluoxetine during the last 6 weeks.
    E.5 End points
    E.5.1Primary end point(s)
    Peripheral monocyte COX-2 (PGE-2) expression, the RNA monocyte signature and the serum ratio of tryptophan/kynurenine will be measured.
    The HamD-17 rating scale score and the Montgomery Asperg Depression Rating Scale score will be determined by investigators who will be trained in the use of these rating scales.
    The safety assessments include standard parameters (adverse events, clinical laboratory tests and vital signs) as well as additional cardiovascular safety assessment (at screening) in view of the known class effects of COX-2 inhibitors. Patients with coronary heart disease (CHD) or any other heart disease will be excluded from the study.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Correlation of monocyte COX-2 (PGE-2) expression with clinical response
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    add-on to standart therapy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Follow-up visit of last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 128
    F.4.2.2In the whole clinical trial 128
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Even if the study medication was identified as beneficial in the study, it can not be provided to the patients since
    further studies investigating the efficacy of the medication in major depression are necessary. There is no studyspecific
    provision of further treatment and additional medical care of the patients once their participation in
    the trial has ended. Afterwards the patient will be treated with the antidepressant prescribed by his/her general
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-31
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