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75 active trials for Anorexia Nervosa

Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy

The primary aim of this study is to assess the safety and tolerability of one 25 mg dose of psilocybin in participants with anorexia nervosa based on adverse events (AEs), changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests. The secondary objectives are to explore the efficacy of a single 25 mg dose of psilocybin on eating disorder symptoms and behaviors, body image, anxiety, food related obsessions and rituals, and body weight.

Start: May 2021

New Treatment Perspectives in Eating Disorders: the Efficacy of Non-invasive Brain-directed Treatment

The present study grounds on the possible role of hemispheric lateralization in Eating disorders (ED): specifically, hyperactivity of the right frontal regions in Anorexia Nervosa (AN), and hypoactivity of the right frontal regions in Binge Eating Disorder (BED) and food craving behaviors. Therefore, the investigators hypothesized that active excitatory tDCS over left prefrontal cortex (PFC) (Anode left/cathode right) may aid in altering/resetting inter-hemispheric balance in AN patients, re-establish control over eating behaviors. On the contrary, active excitatory tDCS over right PFC (Anode right/cathode left) may aid in altering/resetting inter-hemispheric balance in BED patients and people with frequent food cravings, decreasing cravings/appetite binge eating behaviors.

Start: July 2014

PRE-GAiN Bone Health Pilot Study

This study will assess the affects of an estradiol hemihydrate transdermal system on bone health in 24 adolescent females aged 12-19 years old with anorexia nervosa. Participants in this study will be randomized 1:1 into 2 groups. One group will receive treatment with a transdermal estrogen patch and the other group will not.

Start: January 2020

Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa

This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to investigate the effect of romosozumab on BMD in women with anorexia nervosa. The investigators will also investigate the safety of romosozumab in women with anorexia nervosa. The investigators hypothesize that 12 months of romosozumab administration will result in an increase in bone mineral density, increase in markers of bone formation and decrease in markers of bone resorption, and improvement in bone microarchitecture in osteopenic women with anorexia nervosa compared with placebo. The extension study will offer subjects 12-month administration of open-label alendronate (an oral bisphosphonate) 70 mg once weekly after the initial 12 month administration of romosozumab or placebo. The investigators hypothesize that 12 months of romosozumab followed by 12 months of open-label alendronate will result in a greater increase in BMD compared to 12 months of placebo followed by 12 months of open-label alendronate. Within the group of women who receive sequential therapy with 12 months of romosozumab followed by 12 months of alendronate, the investigators hypothesize that BMD will be maintained between 12 and 24 months while on alendronate.

Start: August 2021

Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study

This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to investigate the effect of denosumab on BMD in women with anorexia nervosa. The investigators hypothesize that 12 months of denosumab administration will result in an increase in bone mineral density, decrease in markers of bone resorption and improvement in bone microarchitecture in osteopenic women with anorexia nervosa compared with placebo. An optional extension study will offer subjects 12-month administration of open-label alendronate (an oral bisphosphonate) after the initial 12 month administration of denosumab or placebo. We hypothesize that 12 months of denosumab followed by 12 months of open-label alendronate will result in a greater increase in BMD compared to 12 months of placebo followed by 12 months of open-label alendronate. Within the group of women who receive sequential therapy with 12 months of denosumab followed by 12 months of alendronate, we hypothesize that BMD will be maintained between 12 and 24 months while on alendronate.

Start: October 2017

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

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.

Start: September 2021

Impact of an Olfactory Sensory Therapeutic Group for Adolescent Patients With Restrictive Anorexia Nervosa , Pilot Study

Anorexia nervosa is a severe eating disorder of multifactorial origin and for which there is, to date, no specific, standardized and protocolized management for anorexic patients or data on the superiority of anorexia. type of psychotherapy. The literature reports altered olfactory capacities in anorexia nervosa and the effectiveness of sensory-mediated therapies in several mental disorders. This prospective, single-center, randomized and controlled study proposes the evaluation of the therapeutic impact of an olfactory sensory group carried out during the specialized care of patients aged 12 to 20 years, with anorexia. The main objective is to compare the clinical course of eating disorder, using the Eating Attitudes Test-40 (EAT-40) scale score performed at study inclusion and at 9 months at 9 months, of patients participating in an olfactory sensory therapeutic group compared to a body approach therapeutic group. The secondary objectives of this study are to compare between a treatment associated with an olfactory sensory therapeutic group and a body approach therapeutic group, the evolution of the Body Mass Index at 9 months, overall functioning, evolution of cognitive and sensory capacities, and evolution of the therapeutic alliance at 9 months

Start: July 2021

Transdermal Estrogen in Women With Anorexia Nervosa

Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.

Start: August 2020

Relapse Prevention and Changing Habits in Anorexia Nervosa

This study aims to optimize a treatment package for the relapse prevention treatment of AN. In the first phase, we will assess the feasibility and acceptability of a behavioral treatment for patients after acute hospitalization. We will carefully evaluate clinician and patient perspectives on feasibility and acceptability.

Start: July 2021

Online Relapse Prevention Study

The purpose of this study is to collect preliminary data on the feasibility and acceptability of the randomization of two relapse-prevention treatment conditions after discharge from intensive eating disorder (ED) treatment: an imaginal exposure therapy and a writing and thinking intervention. The second aim to test for (a) differences between the two treatments for the prevention of relapse and (b) preliminary change on clinical ED outcomes (e.g., ED symptoms, fears). The investigators further aim to examine the two treatments target fear extinction and if fear extinction is associated with ED outcomes. The investigators also plan to test if baseline differences in fear conditioning relate to change in ED outcomes across treatment.

Start: June 2021

Outcomes of a Skill-Based Program for Eating Disorders

This study aims to measure the effect of a neurobiologically-guided intensive family based treatment for adults with anorexia nervosa.

Start: February 2015

Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

This Open-Label Pilot Study Aims to Determine Whether a Two-Part Sequenced Out Patient Procedure Utilizing a Modified Ketogenic Diet Followed by a Series of Titrated Ketamine Infusions Results in Improvement or Remission of Chronic Anorexia Nervosa in Adults with Symptoms of Anorexia for at Least 3 Years Despite Treatment Involving at Least 2 Different Modalities. The Hypothesis is That the Diet Addresses Core Metabolic Deficits in the "Anorexic Brain" and Primes the Response to Ketamine.

Start: April 2021

Imaginal Exposure II Study: In-Vivo

The purpose of this study is to test if imaginal exposure therapy can decrease symptoms of eating disorders and anxiety.

Start: May 2017

Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa

Approximately 20% of anorexia nervosa cases do not respond to conventional management strategies: cognitive behavioral therapy, weight gain contract, drug treatments, etc ... - whether they are applied outpatients or during very long hospitalizations. These situations of chronic evolution are characterized by a high rate of mortality. Brain stimulation could be an alternative therapy for these patients. tDCS (transcranial direct current stimulation) is a non-invasive stimulation technique that has demonstrated beneficial effects in other psychiatric conditions such as major depression or schizophrenia. The objectives of the study will be to evaluate the efficacy of tDCS in anorexia nervosa resistant to conventional treatments on weight gain, eating behavior, psychological and nutritional behavioral scales, cognition, connectivity and brain activity.

Start: October 2020

Cognitive Training for Patients With Eating Disorders

Eating disorders are severe mental illnesses, mainly affecting adolescent- and young adult women. The prognoses for eating disorders are relatively poor, and a large part of patients with these illnesses do not benefit from available conventional therapies. After decades of research into the causes of eating disorders, there is now compelling evidence for specific neuropsychological difficulties in patients affected by eating disorders. These neuropsychological difficulties are characterized by cognitive and behavioral rigidity (poor set-shifting abilities), as well as difficulties related to central coherence, planning and impulse control. Surprisingly, few therapies specifically target these difficulties, and they are rarely incorporated into treatment. Cognitive Remediation Therapy has shown promising results as an adjunctive therapeutic intervention for patients with anorexia Nervosa. The primary aim of this randomized controlled trial is thus to investigate the effect of Cognitive Remediation Therapy on neuropsychological function, symptoms of eating disorders and general mental health, quality of life and motor activity in women with both eating disorders (transdiagnostic) and these specific cognitive difficulties.

Start: March 2019

Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

The primary aim of this study is to assess the acceptability and efficacy of treating anorexia nervosa with psilocybin. The secondary aim of this study is to use Magnetic Resonance Imaging (MRI) and Electroencephalography (EEG) to examine the neuronal underpinnings of treatment with psilocybin in this patient group.

Start: May 2021

rTMS for Aneroxia Nervosa in Youth

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.

Start: April 2021

Reward Systems and Food Avoidance in Eating Disorders

The researchers plan to explore brain networks involved in emotion processing and learning using a brain scan and test meals. One core feature of Anorexia Nervosa (AN) is eating a small number of high-calorie or high-fat foods. By studying why individuals with AN are disgusted by food or other eating situations, the researchers will be able to understand more about the neurobiological pathways that lead to restricting food intake and food avoidance. This study also aims to find whether one of two short-term interventions (Interoceptive Exposure (IE); Family-Based Therapy (FBT)) affects connections in the brain and if the treatments affect food avoidance. IE is an intervention that helps reduce anxiety about eating. FBT is an intervention that motivates patients to eat through working with family to increase the value of eating and decrease the value of avoiding foods.

Start: November 2016

Study of the Difference Between Anorexia Nervosa With a History of Psychological Trauma and Classical Anorexia Nervosa on the Neurocognitive and Neurophysiological Factors

Recent studies suggest that patients with an history of trauma may represent a specific subtype of anorexia nervosa (AM) underlined by specific neurobiological and psychopathological mechanisms. Thus, AM-T subjects would manifest cognitive (specific difficulties in executive functions), emotional (emotional disruption, impulsivity, etc.) and neurobiological (secretion of kynurenine and neurokinins in the face of stress) caracteristics different from those of AM subjects.

Start: April 2021

Meal-Based Exposure and Response Prevention in Anorexia Nervosa

Patients with anorexia nervosa (AN), a serious psychiatric disorder, exhibit restricted dietary intake and endorse fear of consuming calorie-dense foods, which in turn drives weight loss. Premorbid anxious personality traits and comorbid anxiety disorders are common in patients with AN. Although intensive behavioral treatment programs can achieve weight restoration in a majority of adults with AN, relapse rates are high. Predictors of relapse include elevated state anxiety and low dietary variety, including lower intake of fat, after discharge, which suggests that relapse following weight restoration may be related to inadequate fear extinction to high energy density (ED) foods during treatment and consequent resumption of restrictive eating patterns. Despite evidence of anxiety's role in the onset and maintenance of restricted eating behavior, utilizing exposure and response prevention (EX-RP) and meal-based interventions to reduce food-related fears is understudied. EX-RP is the gold standard of treatment for Obsessive Compulsive Disorder (OCD). This proposal aims to test the efficacy of an adjunct meal-based EX-RP intervention to reduce food-related fears during intensive behavioral weight restoration in hospitalized patients with AN in comparison to a control treatment, Motivational Interviewing. The investigators will assess changes in a) self-reported anxiety regarding consumption of high-ED foods, b) physiological (skin conductance and heart rate variability) responses to imagined consumption of food items elicited utilizing a visual food cue task, and c) caloric intake of a challenging test meal pre- and post-treatment. A secondary aim is to assess the relationship of early treatment response to EX-RP, operationalized as a reduction in self-reported anxiety within the first three weeks of treatment, and end-of-treatment as well as six-month post-discharge outcomes. Helping patients tolerate food-related anxiety and increase dietary variety across meal contexts may augment treatment effectiveness in adult patients during intensive treatment for AN and has potential to decrease relapse rates.

Start: November 2018