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    The EU Clinical Trials Register currently displays   38003   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2010-021044-17
    Sponsor's Protocol Code Number:CLOCK_depression
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-08-02
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2010-021044-17
    A.3Full title of the trial
    The effect of agomelatine on CLOCK gene expression in patients with major depressive disorder and healthy controls: an exploratory study.
    A.4.1Sponsor's protocol code numberCLOCK_depression
    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 SponsorMedizinische Universität Wien
    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 Valdoxan
    D. of the Marketing Authorisation holderServier Laboratories Limited
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.1Product nameagomelatin
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNAGOMELATINE
    D.3.9.1CAS number 138112762
    D.3.9.2Current sponsor codeValdoxan-H-C-915-IA-03
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major depressive disorder (MDD), Seasonal affective disorder (subtype of MDD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10012378
    E.1.2Term Depression
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    Patients with MDD will be post hoc stratified, based on the DSM-IV seasonal pattern specifier (gene expression profiles before and after agomelatine treatment will be compared between MDD and SAD)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects:
    • Female or male
    • Caucasian
    • Age 18-65 years
    • Blood pressure <160/100 (measured after 5 minutes in supine position)
    • Healthy defined as absence of relevant disease or laboratory findings as defined by the investigator
    • Signed informed consent
    • Ability to comprehend the full nature and purpose of the study
    • Negative pregnancy test at screening in women with childbearing potential
    • No jet lag, shift work, sleep disorders according to ICD 10 or other events interfering with the chronobiological routine within 2 weeks preceding the first study day.
    • No participation in drug trials within 1 month before the first study day.
    • No high risk of suicide or a previous suicide attempt within 6 months before the first study day (score >2 on HDRS item 3).

    Study group 1 (healthy volunteers)
    • No intake of psychotropic drugs within the preceding month
    • Global seasonality score (GSS) lower than 6
    • No personal or family history (parents and siblings) of affective disorders or relevant diseases, as defined by the investigator (according to MINI (Sheehan et al., 1998)

    Study group 2 (Patients with MDD including SAD)
    • Fulfilled criteria for a moderate or severe episode of recurrent major depressive disorder (296.32, 296.33) assessed with Structured Clinical Interview for the DSM-IV (SCID) (First et al., 1996). Furthermore patients with SAD must fulfill the criteria for the seasonal pattern specifier according to the DSM-IV-TR
    • Healthy defined as absence of relevant laboratory findings or disease other than MDD (including SAD) as defined by the investigator.
    • total Hamilton Depression Rating score (HDRS) of >12
    Structured Interview Guide for the Hamilton Depression Rating Scale,
    (HDRS, 21 items, Hamilton, 1960)
    • No axis-I co morbidity (according to MINI) (Sheehan et al., 1998)
    • No intake of psychotropic drugs during the following timeframes before the first study day:
    - 1 week for most antidepressants (including herbal medication), zolpidem and zopiclone, systemic corticosteroids, ACTH, central alpha-adrenergic agonists, reserpine, methyldopa, exogenous melatonin, and opioides;
    - 2 weeks for nonselective MAO inhibitors, benzodiazepines, and buspirone;
    - 3 weeks for fluoxetine (if the duration of treatment had been longer than 7 days);
    - 4 weeks for lithium, antiepileptics, barbiturates, and antipsychotics;
    - 6 months for long-acting depot neuroleptics.
    E.4Principal exclusion criteria
    2.5.3 Exclusion criteria
    • History of relevant diseases as defined by the investogator
    • Known affective disorder (healthy subjects only)
    • HIV or Hepatitis B/C positive virology
    • Any drug intake 1 week prior to the first study day (excluding hormonal contraceptives)
    • No stable intake of concomitant medication (other than psychotropic drugs) during 4 weeks prior to study day 1.
    • Presence of relevant illness within the last 3 weeks
    • Suspected non-compliance with study instructions and life-style requirements
    • Alcohol or drug abuse
    • Blood/Plasma donation within 4 weeks prior to the study day
    • Healthy subjects with a subsyndromal SAD or a “out of range” result in the
    Neuropsychological test
    • High risk of suicide or a previous suicide attempt within 6 months before the first study day (score >2 on HDRS item 3).
    • Pregnant or lactating women
    E.5 End points
    E.5.1Primary end point(s)
    Differences in leucocyte gene expression between healthy subjects and patients before and after agomelatine treatment over 14 days including:
    • Rhythmic 24hour mRNA expression of CLOCK genes
    • Differences in transcript levels of specific CLOCK genes
    • Differences in the genome-wide gene expression
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    evaluator blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    drug given to healthy volunteers
    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 No
    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
    defined as last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    Patients with MDD or SAD will be scheduled to review their treatment (e.g. dose adjusting, switch to another medication or treatment) according to their needs together with a psychiatrist.
    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 Decision2010-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-11-04
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