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    Summary
    EudraCT Number:2021-000133-13
    Sponsor's Protocol Code Number:2020-01131
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-06
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2021-000133-13
    A.3Full title of the trial
    Glucocorticoid enhancement of food exposure therapy in Binge Eating Disorder
    Glukokortikoid-gestützte Nahrungsmittelexposition bei Binge Eating Störung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Glucocorticoid enhancement of food exposure therapy in Binge Eating Disorder
    Glukokortikoid-gestützte Nahrungsmittelexposition bei Binge Eating Störung
    A.3.2Name or abbreviated title of the trial where available
    GEAR
    A.4.1Sponsor's protocol code number2020-01131
    A.5.4Other Identifiers
    Name:DRKSNumber:DRKS00024066
    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 SponsorUniversitätsmedizin Göttingen
    B.1.3.4CountryGermany
    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 supportDeutsche Forschungsgemeinschaft
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsmedizin Göttingen
    B.5.2Functional name of contact pointGEAR-Projektmanagement
    B.5.3 Address:
    B.5.3.1Street AddressVon-Bar-Straße 2/4
    B.5.3.2Town/ cityGöttingen
    B.5.3.4CountryGermany
    B.5.4Telephone number+4905513960825
    B.5.5Fax number+4905513960846
    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.2.1.1.1Trade name Hydrocortison 10 mg JENAPHARM®
    D.2.1.1.2Name of the Marketing Authorisation holdermibe GmbH Arzneimittel
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNHYDROCORTISONE
    D.3.9.2Current sponsor code3000401.00.00
    D.3.9.4EV Substance CodeSUB08065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboTablet
    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
    Binge-Eating-Disorder
    E.1.1.1Medical condition in easily understood language
    Binge-Eating-Disorder
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level PT
    E.1.2Classification code 10004716
    E.1.2Term Binge eating
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The central research question of this project is whether a combination of (food) exposure with response prevention (ERP) and cortisol is superior to ERP under placebo in terms of the reduction of craving for food in Binge Eating Disorder (BED). We expect this hypothesised effect because of favourable effects of cortisol on crucial learning processes (inhibition of memory retrieval and enhancement of new memory consolidation). Secondary research
    questions encompass whether ERP and cortisol is superior to ERP and placebo in terms of the reduction of fear of loss of control over eating, food-
    induced distress, food intake, and episodes of binge eating.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 - 40 years of age
    2. Patients must meet DSM-5 (APA, 2013) criteria of BED
    3. Willingness and ability to give written informed consent
    4. Female subjects of childbearing potential must agree to use acceptable method(s) of contraception for the full study duration and beyond until the next menstruation. Male subjects must agree to use a condom during sexual contact with females of childbearing potential while participating in this study.
    E.4Principal exclusion criteria
    1. systemic (i.v. or oral) glucocorticoid treatment within the last 3 months
    2. current diagnosis of a psychotic, bipolar, or substance use disorder
    3. severe somatic illness (e.g. cancer, cardiovascular disease, instable diabetes mellitus; blood pressure ≥ 160/100 mmHg at rest and/or current treatment of hypertensive crisis within last 6 months)
    4. current or planned use of psychotropic medication (during the period of the study)
    5. current or planned psychotherapy (during the period of the study)
    6. known hypersensitivity to hydrocortisone
    7. known hereditary galactose intolerance
    8. known lactase deficiency
    9. known glucose-galactose malabsorption
    10. known pheochromocytoma
    11. Simultaneous participation in another interventional trial
    12. Pregnant or breastfeeding females
    E.5 End points
    E.5.1Primary end point(s)
    Decrease of food craving in response to real food 3-5 days after treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Day -7 to Day 0 before randomisation and 3-5 days after treatment
    E.5.2Secondary end point(s)
    decrease in fear of loss of control over eating and arousal/distress in response to real food, food craving in response to visual food cues, amount
    of food intake, trait level food craving 3-5 days after treatment and 1 month after treatment, decrease in number of days and episodes of binge eating and overeating 1 month after treatment, 3-5 days after treatment and 1 month after treatment, and continuous decrease in food craving, fear of loss of control over eating and arousal/distress during intervention sessions
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Day -7 to Day 0 before randomisation and 1-6 days, 3-8 days, 5-10 days and 1 month after treatment
    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 Yes
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 50
    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 state50
    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 Decision2022-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-05
    P. End of Trial
    P.End of Trial StatusOngoing
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