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75 active trials for Anorexia Nervosa

Floatation-REST and Anorexia Nervosa

The study proposed in this protocol aims to document the effect of Floatation-REST (reduced environmental stimulation therapy) on symptoms of anorexia nervosa.

Start: March 2018

PROspective Longitudinal All-comer Inclusion Study in Eating Disorders

The PROLED study is a prospective and longitudinal study of patients with Eating Disorders. Annual interviews and collection of biological samples are done, as well as during changes in disease course e.g. during hospitalization. Included are qualitative interviews, psychometric tests, questionnaires which are used to collect data on psychopathology. There is also collection of blood, urine and faeces.

Start: January 2016

Evaluation of the Communities of Healing Mentorship/Support Group Program: Assessment of Preliminary Efficacy

The goal of the study is to evaluate two 6-month adjunct interventions (peer mentorship and social support mentorship) for individuals with eating disorders. Individuals will be randomized to peer-mentorship, social support mentorship, or a wait-list and eating disorder symptoms will be evaluated at baseline and post-treatment.

Start: October 2017

Relapse in Anorexia Nervosa. A Cohort Study

The hospitalization in patients with anorexia nervosa has often a short-term success, as weight is restored to a healthy level, but high percentage of patients relapse during the first year following the discharge. Starting from the observation that the relapse rate is lower in outpatient than in inpatient settings, the investigators hypothesized that the reason of this difference is the nature of inpatient treatment and post-inpatient therapy. For this reason, different procedures and strategies have been implemented during hospitalization to reduce the relapse after discharge. The aim of the study was to assess the time and the percentage of relapse after inpatient discharge and at follow-up.

Start: May 2020

Health Related Quality of Life for Patients With Anorexia Nervosa in Denmark.

Eating disorders (ED) comprise a multitude of symptoms involving a disturbed body image and a preoccupation with food or bodyweight. EDs are often difficult to treat, in part due to the lack of motivation for improvement. Anorexia nervosa (AN) has the highest mortality rate of any psychiatric disease, and less than half of patients will recover from the disease. Studies have found that patients suffering from AN have impaired health-related quality of life (HRQoL) compared to the general population. It has also been suggested that despite improvement in clinical parameters, patients report deterioration in HRQoL, which is in line with a study finding low agreement between patient perceived outcome and clinician assessed characteristics. To evaluate the patients' perception of their disease, it is important to develop reliable and valid assessment tools. Previously generic questionnaires have been used to assess HRQoL in Danish ED patients, as no disease-specific questionnaires have been developed. Translating and validating a disease-specific questionnaire would provide a useful tool in assessing current treatment and in developing new treatment options. This study aimed to develop a Danish version of an internationally disease-specific HRQoL questionnaire. Furthermore, HRQoL is assessed in patients who have gone through shorter or longer treatment.

Start: March 2017

Whole Gut Microbiome Sequencing in Patients With Anorexia Nervosa

Background. Anorexia nervosa (AN) still carries the highest fatality rate of any psychiatric disease, and less than half of the patients recover, completely refractory to any treatment. The etiology remains unknown and evidence for treatment is lacking. The intestinal microbiota and its microbiome provide humans with additional gene products which may be regarded as an organ, which contributes to multiple host metabolic pathways. Recent advances in microbial DNA sequencing technologies have resulted in metagenomic DNA analysis of whole ecosystems such as the human gut. Altered intestinal microbiota has been related to obesity and insulin resistance. Hypothetically, the intestinal microbiota could play a role in the generation and/or maintenance of the emaciation in AN. Aim. The aim of the present study is to investigate whether gut microbiota is altered in patients with AN. Subjects and methods. A cross sectional study of the gut microbiome profiles in 75 clinical, psychometric and biochemical well characterized treatment seeking females with AN. The microbiome profiles are compared with 75 age- matched healthy Danish control subjects. Perspectives. Clarifying whether the intestinal flora is implicated in the susceptibility to or maintenance of AN may provide the basis for development of new highly required treatments.

Start: September 2014

Re-nutrition in Severe Anorexia Nervosa

In anorexia nervosa (AN) it still remains to be clarified, which psychiatric symptoms are the direct consequence of malnutrition and adaptation to starvation and which are not. There is clinical consensus that depression/anxiety and cognitive impairments in AN mainly are sequelae to the malnutrition. However, this consensus is largely based on experimental starvation studies of healthy subjects back in 1940s and from famine- and food programs in the third world, whereas evidence from studies on AN is lacking. The main objective of the study is in the detail to elucidate the short-term changes in the psychopathological profile, depression, anxiety, and cognitive functions in relations to intensive nutritional rehabilitation with weight gain of 10-30% in a specialized medical stabilization unit. Secondarily, it is examined whether cortisol levels are associated with depression/anxiety symptomatology and cognitive impairments. The hypothesis is that an improvement in nutritional status over a short time leads to clinically significant improvements in psychopathology and cognitive functions, which remain 2-3 months after discharge, making the patients more accessible to psychotherapy.

Start: March 2016

Remission Factors in Anorexia Nervosa

Anorexia Nervosa (AN) is a complex and multifactorial psychiatric disease that affects mostly women and is characterized by a self-restriction of food intake leading to life-threatening consequences whose underlying mechanisms are largely unexplored. AN encompasses a constellation of risk factors including genetic, biological, neuro-psychological and social factors. Although AN has a prevalence of only 1-3% in the general population, it has the highest mortality rate amongst any psychiatric disorder. Recovery of normal feeding behaviour in patients often requires several months with a large between-patient variability and a high percentage of relapse, which can occur in 35 to 41% of the patients. There is a huge unmet need for optimal understanding of processes underlying relapse. Reward processing abnormalities represents an important hypothesis underlying AN development and perpetuation. We aim to investigate the mechanisms that contribute to the maintenance and chronicity of the disease after inpatient treatment with a longitudinal design across intensive standardized inpatient treatment. We will challenge our hypothesis through brain imaging, neuropsychological, metabolic and genetic approaches. One hundred twenty-five AN female patients admitted for intensive inpatient treatment will be recruited and evaluated: at admission, after weight recovery and at 6 months after discharge with neurocognitive tests (including the Delay Discounting Task), genetic/epigenetic examination, hormonal blood samples (at each visit and repeated sampling around a meal for a 10-patient subgroup) and brain imaging (including fMRI during a Delay Discounting Task for fifty patients). One hundred healthy controls will be also recruited and be subjected to the same study procedures.

Start: September 2020

The ITA Model of Integrated Treatment of Eating Disorders

This is a naturalistic study implementing a routine assessment to monitor the evolution of the patients with eating disorders being treated in various centers of "ITA salud mental" in Spain.

Start: November 2017

Inhibitory Control and Eating Disorders

Executive functions are part of the high-level cognitive processes essential to the proper functioning of human cognition. They consist mainly of flexibility, updating and inhibition. Some studies have shown a correlation between executive disorders (impaired executive function) and psychiatric disorders such as obsessive-compulsive disorder or phobias. These executive disorders are related to dysfunctions of the fronto-striatal loops. In addition, other studies have investigated the link that may exist between eating disorders such as anorexia or bulimia nervosa and executive functioning. Anorexia nervosa, bulimia nervosa and binge eating disorders are eating disorders characterized by a dysfunction in food intake with restriction of food or compulsions as well as strong concerns about the body schema. Concerning the executive functioning, these studies highlight a lack of cognitive flexibility for patients with anorexia nervosa and bulimia nervosa but also dysfunctions depending on the type of pathology (anorexia nervosa or bulimia nervosa). These studies also highlight the beneficial effects of cognitive remediation on people with eating disorders. However, the investigation of the inhibitory control has not yet been specifically studied. Moreover, since eating disorders are structurally different, a comparison between several pathologies would be interesting to consider. The aim of this study is to determine if a dysfunction of inhibitory control can be highlighted in people with eating disorders. This study would also allow further researches about cognitive remediation suitable for the specific difficulties encountered in these diseases.

Start: May 2019

Implementation of Evidence-Based Treatment of Restrictive Eating Disorder With Pronounced Starvation

In the Region Skåne in Sweden, the investigators have developed guidelines for providing intensive and evidence-based treatment during the first month in case of severe restrictive eating disorder with pronounced starvation. The project is aiming at implementing this treatment program in the general Child Psychiatric clinic, with its main focus on the implementation of evidence based family therapy. The study aims to evaluate the implementation of a standardized treatment model during the first month. The outcome will be compared with the patients and families who have been in treatment before the ROCKETLAUNCH project started.

Start: October 2020

Effects of Anorexia Nervosa on Peak Bone Mass

Teenage girls with anorexia nervosa (AN) are at risk for low bone density and low rates of bone accrual, raising concerns regarding acquisition of peak bone mass, an important determinant of future bone health and fracture risk. Important factors contributing to low bone density in AN include low levels of estrogen and insulin like growth factor-1 (IGF-1). While estrogen is important for preventing bone loss, IGF-1 is important for optimizing bone formation. We have shown in a previous study that replacement of estrogen is effective in increasing bone density in teenage girls with AN; however, this increase in bone density remains lower than that seen in normal-weight controls over the same duration, and residual deficits persist. Importantly, the impact of administering replacement doses of IGF-1 with estrogen replacement has not been studied in teenagers with AN. This study will examine the impact of administering recombinant human (rh) insulin like growth factor-1 (rhIGF-1) with estrogen (to mimic pubertal levels of these hormones) versus administration of estrogen alone on bone metabolism in adolescent girls with anorexia nervosa (AN). One aim of this proposal is to investigate whether co-administration of insulin like growth factor-1 (rhIGF-1) with physiologic estradiol replacement to adolescent girls with AN will increase BMD (bone mineral density) more than estrogen monotherapy, and whether bone mass will approach that seen in healthy adolescent girls. An additional aim is to determine whether co-administration of rhIGF-1 with estradiol to mimic the normal pubertal milieu stimulates bone formation through an IGF-1 mediated anabolic effect, increases bone density to a greater extent than estrogen monotherapy, and improves bone mass accrual to approach that in healthy controls. The impact of rhIGF-1 +estradiol versus estradiol alone on bone microarchitecture will also be assessed.

Start: February 2011

Parent Emotion Coaching for Anorexia Nervosa

Family based treatment (FBT) is the evidence based treatment for pediatric anorexia nervosa (AN), but 50% of adolescents do not respond and the consequences for non-response are dire (e.g., 11.5% mortality rate). Expressed emotion and parental warmth are significant mechanisms of treatment outcome in adolescents with AN, which are not explicitly targeted by FBT. The current proposal is a parent emotion coaching skills group designed to augment FBT in the treatment of pediatric AN by arming high expressed emotion families with the skills necessary to implement FBT and improve treatment outcomes (e.g., weight restoration).

Start: June 2020

Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years

The mechanism of bone loss in anorexia nervosa is complex. Marrow adipose tissue seems to play a role in the regulation of bone metabolism. Adipocytes secrete cytokines and adipokines that either stimulate or inhibit adjacent osteoblasts. This study consist to explore the relationship in anorexia nervosa patients with change in bone mineral density and adipokines like leptin, adiponectin and Préf-1 Bone mineral densities will be measure in 180 anorexia nervosa patients at inclusion and every two years during 6 years.It is assessed blood and urinary calcium and phosphate levels, bone remodelling markers and adipokines (leptin, adiponectin and Préf-1)

Start: July 2013

Neural Correlates of Reward and Symptom Expression in Anorexia Nervosa

The objective of this study is to identify the patterns of brain activity in reward circuitry that promote symptoms of anorexia nervosa. This project will compare weight-restored individuals with anorexia nervosa to a non-eating disorder control group on reward brain circuitry patterns in response to typically rewarding cues (i.e., entertaining videos) and disorder-specific restrictive eating cues (i.e., low-fat food choice) using fMRI. In addition, this study will examine which neurobiological reward responses among weight-restored individuals with anorexia nervosa predict objective restrictive eating (measured by laboratory meal intake) and longitudinal risk of relapse one year later.

Start: February 2018

Positive Affect Treatment (PAT) to Target Reward Mechanisms in Anorexia Nervosa

The goal of the proposed research is to determine the extent to which Positive Affect Treatment (PAT), a novel treatment targeting reward mechanisms, can effectively target the psychological reward deficits that maintain anorexia nervosa (AN), and thus improve clinical symptoms.

Start: May 2019

Comparing Real-time fMRI Neurofeedback Versus Sham for Altering Limbic and Eating Disturbances in Anorexia Nervosa

The goal of the purposed research is to extend prior work (STUDY00003758: Real-time fMRI Neurofeedback to Alter Limbic Disturbances in Anorexia Nervosa) on real-time fMRI (rt-fMRI) neurofeedback (focused on amygdala down-regulation) as an innovative neurocircuitry-targeted intervention for anorexia nervosa (AN). This project will include randomization to rt-fMRI or a sham controlled group to answer the following important unresolved question: Does a patient-led procedure aimed at altering brain activity impact limbic circuit function and key eating disorder and psychiatric symptoms in AN above the effect of a matched, but non-targeted sham condition?

Start: March 2020

Eating Disorders Genetics Initiative

The overarching intention of the Eating Disorder Genetics Initiative (EDGI) is to lay the foundation for all future genomic discovery in eating disorders--anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED)--by exploring both genetic and behavioral factors. To do this, information will be collected from 4000 people who have provided DNA samples for the Anorexia Nervosa Genetics Initiative (ANGI) and the same information and DNA will be collected from an additional 16,000 people. The goal is to better understand eating disorders and how they relate to each other so that better treatments can be developed.

Start: June 2020

Excessive Avoidance Behaviors in Anorexia Nervosa: the Role of Reward

This study investigates excessive avoidance behaviors in patients with a diagnosis of Anorexia Nervosa (AN) compared to a healthy control group. The study further examines the role of reward (relief) as a putative factor in maintaining excessive avoidance behaviors in AN.

Start: May 2019

Validation of BodPod in Pediatric Anorexia Nervosa

Anorexia nervosa is a severe cause of undernutrition. It leads to a dramatic decrease of weight with an important modification of the body composition. During the renutrition phase, disharmonious body composition recovery is a relapse factor. Dual X-ray absorptiometry (DXA) is the gold standard to study body composition in children with anorexia nervosa. But, due to technical limits, DXA analysis needs to take in account a potential failure to thrive with an adjustment on height. Moreover DXA needs an irradiation which does not allow close repeat measurements. Since several years, a simple, non-invasive, non-irradiant method for measure of body composition has been developed in pediatrics: the air displacement plethysmography (ADP). Actually, only one device is available for this measurement: the BodPod®. However, feasibility and accuracy of ADP compare to DXA have not been evaluated in pediatric anorexia nervosa. The aim of this study is to compare the accuracy of BodPod® compare to DXA in girls with anorexia nervosa.

Start: June 2020