Clinical Trials for Anorexia Nervosa
There are currently 5 ongoing clinical trials investigating new treatment approaches for anorexia nervosa. These studies are testing different medications including donepezil, oral lidocaine, estradiol, psilocybin, and examining the role of serotonin in brain circuits. The trials are taking place across Europe, including France, Italy, Norway, and Sweden, and are open to female participants aged 10-65 years depending on the specific study.
Clinical trial locations
- France
- Italy
- Norway
- Sweden
Study on the Effects of Donepezil in Patients with Anorexia Nervosa
This French study is testing whether donepezil, a medication commonly used for Alzheimer’s disease, can help improve symptoms in people with the restrictive type of the disorder. The trial focuses on adult women aged 18 to 65 years.
Who can participate: The study is looking for female participants who meet three DSM-V criteria for the condition, specifically the restrictive subtype where food intake is limited. Participants must have a Body Mass Index between 14 and 18.5 kg/m² and a resting heart rate of at least 40 beats per minute.
Who cannot participate: Men and individuals outside the specified age range are not eligible. People who are part of vulnerable populations are also excluded from participation.
What the study involves: The trial uses a double-blind design, meaning neither participants nor researchers will know who receives the actual medication or a placebo. Donepezil is taken orally as a 5 mg tablet daily for three months. Throughout the study, researchers will monitor changes in eating habits, body image perception, body mass index, and psychological well-being using tools like the Eating Disorder Examination Questionnaire.
Investigational drug: Donepezil works by increasing levels of acetylcholine, a chemical in the brain important for memory and learning. Researchers are exploring whether this effect can also help with the symptoms of the eating disorder.
Study of oral lidocaine (ORE-001) to reduce abdominal discomfort and early satiety in patients with anorexia nervosa
This Italian study examines whether oral lidocaine can help reduce stomach discomfort and feelings of early fullness that often make it difficult for patients to eat. The medication is being compared to placebo over a 28-day treatment period.
Who can participate: Female participants aged 18 to 45 years who are currently hospitalized and receiving psychological treatment for at least 3 months are eligible. Participants must have a Body Mass Index above 13, indicating moderate-to-severe condition according to diagnostic standards. Both the restricting type and binge-eating/purging type are included.
Who cannot participate: Men, pregnant or breastfeeding women, and those with a BMI above 17.5 are excluded. People with serious heart, liver, or kidney conditions, substance abuse issues, or severe psychiatric conditions other than the eating disorder cannot participate. Those currently taking medications for weight gain or appetite stimulation are also excluded.
What the study involves: Participants receive either ORE-001 or placebo tablets daily for 28 days. The medication can be adjusted up to 400 mg per day based on individual needs. Researchers monitor feelings of fullness using a Visual Analog Scale, track body weight and food intake at each meal, evaluate sleep patterns, and measure blood markers related to appetite and satiety.
Investigational drug: Oral lidocaine, traditionally used as a local anesthetic, works by blocking nerve signals that transmit sensations of fullness and discomfort. This novel oral application aims to help patients eat more comfortably by temporarily numbing certain nerve endings in the digestive system.
Study on Estradiol for Treating Anorexia Nervosa in Adolescent Girls
This Norwegian study is exploring whether Estrogen Replacement Therapy can improve both psychological and physical symptoms in adolescent girls. The treatment uses a transdermal patch called Estradot containing estradiol, a form of the hormone estrogen.
Who can participate: The study is open to girls aged 10 to 17 years who have been diagnosed with the condition. Participants who also experience anxiety or depression can join the study.
Who cannot participate: Males and individuals who belong to vulnerable populations that might be at higher risk of harm or exploitation are excluded.
What the study involves: This is an open-label trial, meaning both researchers and participants know what treatment is being given. Participants use the estradiol patch, which delivers medication continuously through the skin. Researchers monitor anxiety levels using the STAI-C assessment and specific symptoms using the EDE-Q questionnaire. Secondary assessments include monitoring hormone levels such as cortisol, ghrelin, T3, and T4, as well as weight gain, cognitive performance, and overall mental health scores.
Investigational drug: Estradiol is a hormone that plays an important role in the development and regulation of the female reproductive system. Researchers are investigating whether supplementing estrogen levels can help regulate mood and physical health in girls with this eating disorder.
Study on the Effects of Psilocybin for Young Adults with Anorexia Nervosa
This Swedish study is testing whether psilocybin, a substance found in certain mushrooms, can safely help young adults when combined with psychological support. The treatment is given as capsules containing dry extract from Psilocybe cubensis mushrooms.
Who can participate: Young adults aged 16 to 35 years with a DSM-5 diagnosis are eligible. Participants must have ongoing stable contact with an outpatient psychiatric unit and a BMI greater than 16. Importantly, participants must have experienced at least one period of recovery with a minimum BMI of 17, followed by a return of symptoms.
Who cannot participate: Individuals outside the 16-35 age range and those who are part of vulnerable populations cannot participate.
What the study involves: Participants receive two doses of 25 mg psilocybin, given one month apart, accompanied by psychological support. The treatment is compared to standard care. Researchers monitor for any unwanted effects and assess changes in anxiety, life satisfaction, weight, and symptom severity. A six-month follow-up period tracks whether participants can achieve and maintain weight restoration and psychological well-being.
Investigational drug: Psilocybin affects serotonin receptors in the brain, which can alter mood and perception. Researchers are interested in whether these effects can help change people’s relationship with food and their body image, potentially offering a new approach to treatment.
Study on the Role of Serotonin and Sodium Chloride in Brain Circuits for Food Avoidance in Patients with Anorexia Nervosa
This French study uses advanced brain imaging to understand how serotonin influences brain circuits involved in food avoidance. The goal is to better understand the underlying brain mechanisms of the disorder, which could lead to improved treatments in the future.
Who can participate: Women aged 18 to 35 years with a BMI less than 17.5 kg/m², fear of weight gain, excessive concern about appearance, and absence of menstruation are eligible. The study has two subgroups based on anxiety levels measured by the STAI Y2 test. Participants must have no food compulsions or purging behaviors. They must sign a consent form and be affiliated with a social security scheme.
Who cannot participate: People with other serious medical conditions, those taking medications affecting the brain’s serotonin system, individuals with a history of substance abuse, pregnant or breastfeeding women, those with psychiatric disorders other than the eating disorder, people with neurological disorders, those with significant brain structure abnormalities, and anyone who participated in another clinical trial within the last 30 days are excluded.
What the study involves: This is primarily a research study rather than a treatment trial. Participants undergo various brain imaging procedures including PET scans to measure serotonin activity and MRI scans to assess brain connectivity and structure. Eye-tracking technology monitors gaze patterns during food choice tasks. Participants complete questionnaires about eating behaviors and anxiety levels. The study also measures hormonal and nutritional parameters.
Study purpose: This research aims to identify differences in serotonin transmission in brain networks that control food intake between individuals with and without the disorder. Participants receive an injection of sodium chloride solution as part of the study procedures. The findings will help scientists understand how serotonin affects appetite regulation and food avoidance behaviors.
Summary
These five clinical trials represent diverse approaches to understanding and treating the condition, ranging from repurposing existing medications like donepezil and lidocaine to exploring hormone therapy with estradiol and investigating novel compounds like psilocybin. Two trials are taking place in France, with one each in Italy, Norway, and Sweden, showing a concentration of European research efforts.
The studies target different age groups and aspects of the disorder. Two trials focus specifically on younger populations: the Norwegian estradiol study includes girls as young as 10 years old, while the Swedish psilocybin trial targets young adults aged 16 to 35. The Italian lidocaine study focuses on reducing the physical discomfort that makes eating difficult, while the French donepezil trial examines whether a medication typically used for cognitive function can help with eating disorder symptoms.
All trials are limited to female participants, reflecting the higher prevalence of the condition in women. The studies employ various monitoring approaches, from advanced brain imaging in the French serotonin study to practical measures like weight tracking and psychological assessments in the other trials. These research efforts may provide new insights into treatment options and the underlying mechanisms of this serious eating disorder.
