Binge-Eating-Disorder MedDRA version: 24.0 Level: PT Classification code 10004716 Term: Binge eating System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Hydrocortison 10 mg JENAPHARM®
Pharmaceutical Form: Tablet
INN or Proposed INN: HYDROCORTISONE
Current Sponsor code: 3000401.00.00
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Universitätsmedizin Göttingen
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): Decrease of food craving in response to real food 3-5 days after treatment;Timepoint(s) of evaluation of this end point: At Day -7 to Day 0 before randomisation and 3-5 days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;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 | — |
Countries
Germany
Contacts
Public ContactGEAR-Projektmanagement
Universitätsmedizin Göttingen
Outcome results
None listed