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Anorexia Nervosa clinical trials

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NCT ID: NCT05682417 Not yet recruiting - Anorexia Nervosa Clinical Trials

Impact of Body Schema Distortion on Remission and Weight Regain in Anorexia Nervosa

SCAM
Start date: September 2023
Phase: N/A
Study type: Interventional

Anorexia nervosa is a predominantly female eating disorder that most often appears in adolescence. The latter leads to strict and voluntary food deprivation for several months or even years. The lifetime prevalence of anorexia is 1.4% in women and 0.2% in men. Ultimately, only half of people treated for anorexia nervosa in adolescence recover, 30% simply improve, 21% suffer from chronic disorders and 5 to 6% die. At the same time, between a quarter and half of patients abandon their current treatment, including during hospitalization. Relapses occur during the evolution of anorexia nervosa. Even more worrying, mortality is highest the year following the patient's discharge from hospital. This appears to be due to somatic complications in more than half of cases (most often cardiac arrest), to suicide in 27% of cases. Researchers are still trying to clarify the mechanisms involved in the emergence and persistence of this disorder. The objective is to obtain more verified and faster cures. However, the obstacles to successful treatment are mainly due to the denial of disorders and thinness. From a neurocognitive perspective, the representation one has of one's body is underpinned by two types of representations, i.e. body image and body schema. It has long been shown that body image is altered in anorexia nervosa. More recently, authors have shown that the distortion of the body representation was however more extensive and also affected the body schema. Patients find themselves too fat despite obvious thinness and move through space as if this were really the case. Worryingly, these distortions in bodyschema seem to persist after therapeutic management. Despite the potential role of body-scheme distortions in maintaining the disorder, as well as the risk of relapse, the difficulties in assessing body-scheme are significant. Indeed, recovery in these pathologies is often determined according to the Body Mass Index, self-declaration and questionnaires evaluating body image, again limiting the verification of the resorption of distortions in the body schema. Investigators have therefore developed the systematic, ergonomic and simplified evaluation of the body schema in patients suffering from anorexia nervosa at the time of diagnosis in an expert center, but also during follow-up evaluations thanks to the use of an evaluation platform of the body schema, i.e. the body in brain platform, developed by the LIP/PC2S laboratory and the SATT Linksium which allows the evaluation of the body schema.

NCT ID: NCT05632497 Not yet recruiting - Anorexia Nervosa Clinical Trials

Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa

INT-METAVOSA
Start date: September 2023
Phase:
Study type: Observational

The purpose of this study will be to study the association between the level of psychic symptomatic of anorexia nervosa (AN) (intensity of food restriction, symptoms of anxiety and depression) and alteration of host environment symbiosis and the mechanism (dysbiosis of intestinal microbiota, increase of intestinal permeability, immunity alteration and low-grade inflammation).

NCT ID: NCT05477537 Not yet recruiting - Anorexia Nervosa Clinical Trials

Adapted Physical Activity in the Treatment of Anorexia: a Randomised Control Trial

EfAPA
Start date: January 2023
Phase: N/A
Study type: Interventional

People with anorexia nervosa are known to engage in significant physical activity or sports. This practice is problematic because of the state of malnutrition, its interference with re-nutrition and the somatic and nutritional complications that the effect of physical activity can cause in these people. This significant physical activity is also called hyperactivity in the literature, it is in fact a problematic use of physical activity, it is a symptom commonly observed in people suffering from anorexia nervosa (in 31 to 80% cases). In this context, Ms. Kern lecturer in Sciences and Techniques of Physical and Sports Activities (STAPS) at the University of Paris Nanterre has developed in collaboration with the clinical team (Pre Godart) an adapted physical activity program (APA) , for patients suffering from anorexia nervosa. The APA program includes 8 sessions of 1h30 including an important part of psychoeducation. The effectiveness of this program will be evaluated in terms of both restoration of body mass index and improvement in overall health. The project's hypothesis is that adding a standardized 8-week Adapted Physical Activity program to the usual care, including psychoeducation on both problematic physical activity and the consequences in terms of good practice of physical activity leads to a better outcome of overall care in people with anorexia nervosa.

NCT ID: NCT05290285 Not yet recruiting - Anorexia Nervosa Clinical Trials

Amino Acids in Patients With Anorexia Nervosa: Double-blind Randomized Study Versus Placebo

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Amino acids (AAs) are crucial for protein synthesis, in influencing nutritional status, as sources of vital elements (e.g., nucleotides, neurotransmitters) and as signal molecules for the modulation of gene expression and epigenetic mechanisms. Data on the role of amino acids in underweight patients with anorexia nervosa (AN) are unknown. This study aims to evaluate whether a blend of essential amino acids (EAA) could influence the change in lean body mass (LBM) in patients with AN during weight restoration, treated with intensive inpatient enhanced cognitive behavior therapy (CBT-E). A total of 92 patients will be randomized to EAA supplementation or placebo supplementation upon admission to inpatient treatment. LBM, but also body weight, specific and general psychopathology, impairment assessment will be assessed at baseline and after 13 weeks of treatment.

NCT ID: NCT04846517 Not yet recruiting - Anorexia Nervosa Clinical Trials

rTMS for Aneroxia Nervosa in Youth

MULTI-REX
Start date: November 30, 2024
Phase: N/A
Study type: Interventional

This study will examine the feasibility of off-label multilocus repetitive transcranial magnetic stimulation (rTMS) for symptoms of Anorexia Nervosa in participants between the ages of 14-24. rTMS is a non-invasive, brain-based intervention that uses magnets to deliver energy to the brain. The investigators will also see if patients receiving multilocus rTMS show any improvements in their eating disorder, mood, anxiety, and obsessions and compulsions (if present). Participants will receive daily intervention with off-label multilocus rTMS for 20 total treatments. Participants will also be asked to complete mental health and well-being surveys, physical measurements, and 2 brain imagining scans (MRIs) at baseline, and at study end. The investigators will also ask participants to complete surveys are 1-month and 3-months after the final rTMS session. The target enrollment for this study is 45 participants.

NCT ID: NCT04817436 Not yet recruiting - Anorexia Nervosa Clinical Trials

Effects of Adapated Physical Activity Program on Kynurenin Metabolism During Refeeding in Anorexia Nervosa : APANOR Study

APANOR
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Physical hyperactivity is often associated to anorexia nervosa (AN). Data suggest common central pathways between hyperactivity and anorexia. Maintaining adapted physical activity (APA) during refeeding in AN is controversial. Many studies suggest beneficits of APA in AN on body composition (increase fat free mass and better distribution of fat mass), mood regulation, bone metabolism. We recently reported benefits of maintaining physical activity during refeeding in a mice model of anorexia (activity-based anorexia model). These benefits involved the tryptophan-kynurenin pathway. Thus, we aim in the APANOR study to assess effects of APA during refeeding in AN on kynurenin metabolism.

NCT ID: NCT04804800 Not yet recruiting - Anorexia Nervosa Clinical Trials

Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa

PROSANOR
Start date: September 2022
Phase: N/A
Study type: Interventional

Body distortions are responsible for anorexic behavior reinforcing loops. It is necessary to target this behavior and develop appropriate therapies taking into account the perceptual (implicit) and conceptual (explicit) phenomenon of body representations. The main originality of the proposed program consists on combining virtual visual impulses and multisensory recalibration (touch, proprioception, vestibular sensations) in order to compare the body distortions evolution in anorexic patients with or without a multimodal care program including Virtual Reality from its own body scan, coupled or not to a multisensory remediation.

NCT ID: NCT04454684 Not yet recruiting - Clinical trials for Binge-Eating Disorder

A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders

MED1
Start date: February 2026
Phase: Phase 2
Study type: Interventional

This Phase 2, open-label, multi-site study will explore the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy and adjunctive caregiver involvement in the treatment of 18 participants with eating disorders. The study will enroll 12 participants with anorexia nervosa restricting-type (AN-R) and six participants with binge eating disorder (BED). A supportive caregiver, such as a parent or partner, for each participant will also be recruited to participate in the study and receive non-drug psychotherapy support. The study will consist of Preparatory Sessions, Experimental Sessions of MDMA-assisted psychotherapy, as well as Individual and Dyadic Integrative Sessions. A flexible dose of MDMA will be given during Experimental Sessions, ranging from 80 to 120 mg with a supplemental half-dose of 40 or 60 mg 1.5 to 2 hours later, respectively, unless contraindicated. The primary outcome measure is the change in Eating Disorder Examination (EDE) results from Baseline to Visit 16 (Study Termination).

NCT ID: NCT04095741 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Characteristics of Autism Spectrum Disorder in Minors With Anorexia Nervosa in Remission

Start date: October 1, 2019
Phase:
Study type: Observational

With this investigation, researchers wil look for a link between the appearance of anorexia nervosa and autism spectrum disorders in minors. Previous studies made clear already that patients with anorexia nervosa show elevated characteristics of autism spectrum disorder, when being meassured in adults and in patients in the acute fase of their anorexia nervosa. The purpose of this invenstigation is to see if their is also an elevated incidence of characteristics of autism spectrum disorder in minors with anorexia nervosa in remission.

NCT ID: NCT03600610 Not yet recruiting - Anorexia Nervosa Clinical Trials

Evaluation of CARdiac Abnormalities by Echocardiography and MRI in Malnourished Patients Suffering From Anorexia Nervosa

CARERA
Start date: September 2018
Phase: N/A
Study type: Interventional

Anorexia nervosa is an eating disorder occurring in adolescent females, characterized by voluntary dietary restriction, intense fear of gaining weight, and disturbed body image perception. Anorexia nervosa is characterized by the potential severity of its prognosis. While complete remission occurs in about 50% of cases, up to 20% of patients will develop a chronic relapsing form that leads to social disintegration. Moreover, anorexia nervosa has the highest mortality rate among psychiatric diseases with a risk of death of up to 10%. 30% of deaths in anorexia nervosa are attributed to cardiac complications remaining insufficiently described, and their screening at a preclinical stage is still poorly codified. Echocardiography findings show reduced left ventricular mass, pericardial effusion or mitral valve prolapse ; in addition, systolic function appears to be preserved whereas a global diastolic dysfunction, estimated with trans-mitral flow and global longitudinal strain. While the interest of cardiac echography has been well established, only one study used MRI as a means of cardiac evaluation in anorexia nervosa: interestingly, local myocardial fibrosis is pointed and could potentially contribute to cardiac rhythm disorders. No study has yet used T1-Mapping MRI to evaluate if diffuse myocardial fibrosis is prevalent in this population group. The investigators conduct a transversal, observational, monocentric study whereby malnourished patients with anorexia nervosa and age- and sex- matched, normal weight, healthy volunteers will undergo a gadolinium-enhanced cardiac MRI. The primary objective of this study is to evaluate and compare the frequency of cardiac fibrosis in those populations. Other cardiac MRI parameters will be described and compared as secondary objectives. Moreover, non-cardiac parameters evaluated by MRI such as adipose tissue distribution in anorexia nervosa patients compared with controls. In addition, patients with anorexia nervosa, a clinical, morphological and biological evaluation, including anthropometric parameters, biphotonic absorptiometry, resting electrocardiogram, cardiac echography and classical biological markers of malnutrition, will be done.