E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behaviours [F01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 24.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10004716 |
E.1.2 | Term | Binge eating |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Decrease of food craving in response to real food 3-5 days after treatment |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At Day -7 to Day 0 before randomisation and 3-5 days after treatment |
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E.5.2 | Secondary 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 |
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E.5.2.1 | Timepoint(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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |