Ongoing Clinical Trials for Binge Eating Disorder
Currently, there are 2 ongoing clinical trials investigating new treatment approaches for binge eating disorder. These studies are taking place in Germany, France, and Spain, testing different therapeutic strategies including medication combined with behavioral therapy and novel pharmaceutical compounds. The trials focus on reducing the frequency of binge eating episodes and improving control over eating behaviors in adults with moderate to severe symptoms.
Clinical trial locations
- France
- Germany
- Spain
Study on Hydrocortisone and Food Exposure Therapy for Patients with Binge Eating Disorder
This trial, conducted in Germany, explores a combination treatment approach that pairs food exposure therapy with hydrocortisone medication. The study aims to determine whether this combination is more effective than food exposure therapy alone in reducing food cravings and improving control over eating behaviors.
Who can participate: The trial is open to both men and women between 18 and 40 years of age who have been diagnosed with binge eating disorder. Participants must be able to understand the study procedures and provide written informed consent. The upper age limit is set to avoid potential effects from hormonal changes related to menopause.
Who cannot participate: Individuals without a confirmed diagnosis of binge eating disorder are not eligible. Additionally, people considered vulnerable, such as those unable to give informed consent, cannot take part.
What the study involves: Participants receive either hydrocortisone tablets (10 mg taken orally) or a placebo with no active medication. During treatment sessions, participants are exposed to real food while their response is monitored. The study tracks changes in food cravings, feelings of losing control over eating, and emotional responses to food. Follow-up assessments occur 3-7 days after treatment and continue for up to one month to evaluate long-term effects.
Investigational treatment: The trial uses hydrocortisone, a type of glucocorticoid hormone that influences the body’s stress response. Combined with food exposure therapy with response prevention, this approach aims to alter how the brain processes cravings and stress-related eating behaviors. The therapy component involves exposing individuals to food in a controlled setting while preventing their usual response of binge eating.
Study on BP1.4979 for Treating Binge Eating Disorder in Women with Moderate to Severe Symptoms
This trial, taking place in France and Spain, tests a new medication called BP1.4979 specifically in women with moderate to severe binge eating disorder. The study evaluates both the effectiveness and safety of this medication over an eight-week treatment period.
Who can participate: The trial is limited to women between 18 and 65 years of age with a confirmed diagnosis of binge eating disorder according to DSM-5 criteria. Participants must experience at least two days of binge eating per week, with at least 8 episodes recorded in the two weeks before starting the study medication. The Body Mass Index must be less than 50 kg/m². Participants need to be able to keep a diary, attend scheduled visits, take medication as instructed, and have adequate support to follow all study requirements.
Who cannot participate: Men are excluded from this study, as it specifically focuses on female patients. Individuals without a confirmed diagnosis of binge eating disorder or those outside the specified age range cannot participate. People considered part of vulnerable populations may also be ineligible.
What the study involves: The trial uses a double-blind design, meaning neither participants nor researchers know who receives the actual medication versus a placebo. After a 2-week baseline period where binge eating episodes are documented in a diary, participants begin taking BP1.4979 at a dosage of 15 mg twice daily for 8 weeks. Throughout the treatment period, participants continue recording binge eating episodes. The study includes various assessments such as continuous glucose monitoring to track dietary patterns, the Yale Food Addiction Scale to evaluate food addiction symptoms, and the Clinical Global Impression scale to assess overall clinical status.
Investigational treatment: BP1.4979 is an oral medication taken as a tablet twice daily. It is classified as a central nervous system agent and is believed to work by modulating neurotransmitter activity in the brain, which may help reduce the frequency and intensity of binge eating episodes. This trial represents the first study of this compound for treating binge eating disorder.
Summary
These two ongoing clinical trials represent different approaches to treating binge eating disorder. The German study combines behavioral therapy with hormonal medication accessible to both men and women aged 18-40, while the French and Spanish trial tests a novel pharmaceutical compound exclusively in women aged 18-65. Both studies share the common goal of reducing binge eating episodes and improving control over eating behaviors, but they differ in their therapeutic strategies and target populations.
The geographic distribution shows research activity concentrated in Western Europe, with one trial in Germany and another spanning France and Spain. One notable difference is that the hydrocortisone study includes both genders, whereas the BP1.4979 trial focuses specifically on women with moderate to severe symptoms. Both trials require confirmed diagnosis of binge eating disorder and exclude vulnerable populations unable to provide informed consent.
These studies offer opportunities for individuals struggling with binge eating disorder to access potentially innovative treatments while contributing to medical knowledge about this condition. Interested individuals should consult with their healthcare providers to determine if they meet the specific eligibility criteria for either trial.
