Glucocorticoid enhancement of food exposure therapy in Binge Eating Disorder

Phase 2

Recruiting

• Conditions: Binge Eating Disorder

• Registration Number: 2024-515475-35-00
• Lead Sponsor: Universitaetsmedizin Goettingen

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Patients with BED according to DSM-5

Male or female patients aged between 18 and 40 (the upper age limit was chosen to minimise potential confounding effects by hormonal changes related to menopause)

Written informed consent obtained according to international guidelines and local laws

Ability to understand the nature of the trial and the trial related procedures and to comply with them.

Exclusion Criteria

systemic (i.v. or oral) glucocorticoid treatment within the last 3 months

known pheochromocytoma

Simultaneous participation in another interventional trial

Pregnant or breastfeeding females

current diagnosis of a psychotic, bipolar, or substance use disorder

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)

current or planned use of psychotropic medication (during the period of the study)

current or planned psychotherapy (during the period of the study)

known hypersensitivity to hydrocortisone

known hereditary galactose intolerance

known lactase deficiency

known glucose-galactose malabsorption

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
decrease of food craving in response to real food 3-7 days after treatment		decrease of food craving in response to real food 3-7 days after treatment

Secondary Outcome Measures

Name	Time	Method
food craving in response to visual food cues		food craving in response to visual food cues
amount of food intake		amount of food intake
decrease in fear of loss of control over eating and arousal/distress in response to real food		decrease in fear of loss of control over eating and arousal/distress in response to real food
trait level food craving 3-7 days after treatment and 1 month after treatment		trait level food craving 3-7 days after treatment and 1 month after treatment
decrease in number of days and episodes of binge eating and overeating 1 month after treatment		decrease in number of days and episodes of binge eating and overeating 1 month after treatment
continuous decrease in food craving		continuous decrease in food craving
fear of loss of control over eating and arousal/distress during intervention sessions		fear of loss of control over eating and arousal/distress during intervention sessions

Trial Locations

Locations (1)

Universitaetsmedizin Goettingen; 🇩🇪 Goettingen, Germany

Universitaetsmedizin Goettingen

🇩🇪Goettingen, Germany

Christoph Herrmann-Lingen

Site contact

+495513964900

cherrma@gwdg.de