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    Summary
    EudraCT Number:2017-003331-10
    Sponsor's Protocol Code Number:HC03
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-19
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-003331-10
    A.3Full title of the trial
    Acute effects of 40 mg cortisol on emotion and cognition.
    Acute effecten van 40 mg cortisol op emotie en cognitive.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cortisol, Emotion and Cognition
    Cortisol, Emotie en Cognitie
    A.4.1Sponsor's protocol code numberHC03
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLeiden University
    B.1.3.4CountryNetherlands
    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 supportLeiden University, Institute of Psychology
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University
    B.5.2Functional name of contact pointInstitute of Psychology
    B.5.3 Address:
    B.5.3.1Street AddressWassenaarseweg 52
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333AK
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310715274818
    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 No
    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 namehydrocortison
    D.3.2Product code hydrocortison
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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
    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
    None.
    E.1.1.1Medical condition in easily understood language
    None (healthy participants).
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    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 investigate whether single administration of hydrocortisone will prevent the negative effects of stress on cognition and automatic attentional threat processing; participants in the hydrocortisone group will show reduced objectively assessed interference by negative information and self-reported cognitive interference during performance, and better cognitive performance.
    E.2.2Secondary objectives of the trial
    It is expected that frontal EEG theta/beta ratio will predict attentional function in the placebo group and moderate the effects of hydrocortisone on cognition; the group differences for placebo versus cortisol on cognitive performance and automatic attentional threat processing will be most pronounced among participants with higher baseline TBR (low cognitive control).

    Moreover, it is expected that effects of cortisol and moderation thereof by theta/beta ratio will also depend on trait anxiety and self-reported trait attentional control (e.g, Putman et al 2007; Schoorl et al., 2014).

    Finally we expect to replicate the negative relationship between frontal EEG theta/beta ratio and self-reported attentional control (see, Putman et al., 2010, 2014; Angelidis et al., 2016).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) relatively high scores on a self-reported trait cognitive test anxiety scale and trait social anxiety. We will aim at testing participants who score above the population’s median score for this scale, as this should increase the baseline effects of stress on cognition and therefor optimize the study’s design for observing effects of cortisol. For practical reasons and reasons of external validity, we set no strict cut off score for inclusion, but rather pragmatically aim to test the higher scoring of respondents.
    2) females
    3) Age 18-25 years.
    4) Right-handed.
    5) Normal, or corrected to normal vision.
    6) stable (> 3 months) use of monophase orall anti-conceptives (between the 3rd and the 20th day of their menstrual cycle.
    7) 18 < BMI < 26
    8) fluent in Dutch
    E.4Principal exclusion criteria
    1) Treatment for psychiatric, endocrine or neurological (CNS) medical problems in the past or present.
    2) Use of any medication other than occasional use of OTC medications
    3) Use of corticosteroid medication (oral, nasal, injected) in the 6 months prior to enrollment or dermal corticosteroid medication in the week prior to enrollment.
    4) Regular smoking (more than 10 cigarettes per week) or any in the 12 hours prior to testing.
    5) Use of more than three alcoholic units per day.
    6) Frequent or recent use of cannabis (on average once a week or more frequent in the three months prior to enrollment or single use or more in the week prior to enrollment).
    7) Any use of recreational drugs other than cannabis in the three months prior to enrollment.
    8) Use of more than 3 units of alcohol in the last 24 hours, use of alcohol during the last 12 hours, or consumption of any other recreational drug in the last 24 hours prior to testing.
    9) Intensive physical cardiovascular sports training for more than 1 hour, at least 5 days a week.
    10) pregnancy
    11) lactation
    12) Raynaud syndrome
    E.5 End points
    E.5.1Primary end point(s)
    objective and subjective emotional interference, executive cognitive performance,
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 hour after intervention
    E.5.2Secondary end point(s)
    EEG theta/beta ratio, trait cognitive test anxiety, trait attentional control
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 hour before intervention
    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 No
    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.7.1.3.1Other 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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    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.8.2.4Number of treatment arms in the trial2
    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.8.5The 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 No
    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
    LVLS
    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 months7
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Participants with high scores on a trait cognitive test anxiety scale and trait social anxiety
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    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)
    None
    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 Decision2017-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-16
    P. End of Trial
    P.End of Trial StatusCompleted
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