Overview
Sponsor-declared trial summary
Binge Eating Disorder
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).
Key facts
- Sponsor
- Universitaetsmedizin Goettingen
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 20 Mar 2023 → 4 Mar 2026
- Decision date (initial)
- 2024-07-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515475-35-00
- EudraCT number
- 2021-000133-13
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
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).
Secondary objectives 1
- 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.
Conditions and MedDRA coding
Binge Eating Disorder
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.0 | PT | 10004716 | Binge eating | 100000004873 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Trial phase Randomisation into experimental treatment or control treatment.
|
Randomised Controlled | Double | [{"id":69847,"code":2,"name":"Investigator"},{"id":69848,"code":1,"name":"Subject"}] | Experimental Treatment: ERP plus 20 mg Hydrocortison, 3 sessions (approx. 40 min each) on 3 separate days within 7 days (± 3 days), outpatient setting Control treatment: ERP plus placebo, 3 sessions (approx. 40 min each) on 3 separate days within 7 days (± 3 days), outpatient setting |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 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 12
- systemic (i.v. or oral) glucocorticoid treatment within the last 3 months
- 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
- known pheochromocytoma
- Simultaneous participation in another interventional trial
- Pregnant or breastfeeding females
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- decrease of food craving in response to real food 3-7 days after treatment
Secondary endpoints 7
- 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 3-7 days after treatment and 1 month after treatment
- decrease in number of days and episodes of binge eating and overeating 1 month after treatment
- continuous decrease in food craving
- fear of loss of control over eating and arousal/distress during intervention sessions
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Hydrocortison 10 mg JENAPHARM® Tabletten
PRD937240 · Product
- Active substance
- Hydrocortisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB09 — HYDROCORTISONE
- Marketing authorisation
- 3000401.00.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsmedizin Goettingen
- Sponsor organisation
- Universitaetsmedizin Goettingen
- Address
- Robert-Koch-Strasse 40, Weende Weende
- City
- Goettingen
- Postcode
- 37075
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsmedizin Goettingen
- Contact name
- Florian Walker
Public contact point
- Organisation
- Universitaetsmedizin Goettingen
- Contact name
- Florian Walker
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2023-03-20 | 2026-03-04 | 2024-03-03 | 2025-10-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-575475-35-00_forpub | 5.0 |
| Recruitment arrangements (for publication) | GEAR_Document not applicable acc to EMA Guideline on CTIS transition | 1 |
| Subject information and informed consent form (for publication) | L1_GEAR_SIS and ICF_for pub | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_Fachinfo_Hydrocortison_10_Jenapharm | 1 |
| Synopsis of the protocol (for publication) | GEAR_Document not applicable acc to EMA Guideline on CTIS transition | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-02 | Germany | Acceptable 2024-07-18
|
2024-07-23 |