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Anorexia Nervosa clinical trials

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NCT ID: NCT04583774 Active, not recruiting - Anorexia Nervosa Clinical Trials

Developing an EEG Paradigm to Study Prediction Error in Anorexia Nervosa

Start date: February 9, 2021
Phase: N/A
Study type: Interventional

Adolescent anorexia nervosa (AN) is an eating disorder associated with intense fear of weight gain, food refusal, and severe weight loss. AN is the third most common chronic illness among adolescent females with a mortality rate 12 times higher than expected for females 15-24 years old. Little is known about biomarkers in adolescent AN. Neuroimaging studies have repeatedly suggested altered reward processing in AN including in studies using the dopamine associated prediction error (PE) model. The brain PE response is elicited during unexpected receipt or omission of reward stimuli and thought to reflect the functionality of brain dopamine circuits. This is an important research direction as the dopamine system can be manipulated pharmacologically. In ill and recovered adult AN, unexpected or randomly applied sucrose taste stimuli evoked higher insular and striatal responses and unexpected omission or receipt of monetary or taste reward was associated with a similar response pattern in adolescent AN. PE was also inversely related to weight gain in treatment. Thus, PE brain response promises to be an important biological marker for adolescent AN with predictive value for treatment outcome. However, functional brain imaging is costly, prohibitive for instance for individuals with braces or other metal in their body and only available at certain centers. In order to study PE in AN in larger scale studies, a more practical approach and method need to be developed. In this application, we will use the exploratory/developmental R21 mechanism to develop a study protocol using electroencephalography (EEG) to study PE signals in adolescent AN. Recent studies in healthy individuals support that this is a valid approach. Our primary goal for this study is to test the feasibility of the use of EEG for prediction error and reversal learning studies in AN with the longer term goal of replacing fMRI that is costly and associated with frequent participant rule out. In Aim 1. we test the feasibility of adapting a computational taste PE reinforcement learning paradigm from fMRI to EEG in adolescents with AN and healthy controls. We expect that we will find internal consistency of taste PE brain response across fMRI and EEG in adolescents with AN as well as age-matched healthy controls, within each group. We further expect that we will find preliminary evidence that the EEG paradigm will be able to discriminate the AN group from the HC adolescents based on feedback related negativity and higher event-related potential amplitudes, which will correlate with fMRI PE brain response. In Aim 2., we test whether a monetary PE paradigm will show similar EEG brain response as taste PE in Aim 1. to establish the generalizability of EEG taste and non-taste paradigms. The development of an EEG based reward PE study paradigm will enable us in the future to conduct large-scale studies that will be less costly and independent from brain imaging centers that are only available to a small subset of adolescents with AN.

NCT ID: NCT04560517 Recruiting - Anorexia Nervosa Clinical Trials

Remission Factors in Anorexia Nervosa

REMANO
Start date: April 6, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT04505189 Completed - Anorexia Nervosa Clinical Trials

Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

Start date: May 28, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT04481165 Completed - Clinical trials for Adolescents Cared for Anorexia Nervosa at Maison de Solenn

Experience of Adolescents With Anorexia Nervosa Towards Antidepressants

E3A
Start date: July 31, 2020
Phase:
Study type: Observational

The purpose of this study is to explore the experience of adolescents suffering from anorexia nervosa confronted with the prescription of antidepressants

NCT ID: NCT04479683 Recruiting - Clinical trials for Early Onset Anorexia Nervosa

COmparison Between Continued Inpatient Treatment Versus Day Patient Treatment in Early Onset Anorexia Nervosa

COTIDEA
Start date: May 10, 2021
Phase: N/A
Study type: Interventional

"In so-called ""early onset"" anorexia nervosa (AN), a rare and severe form affecting 8-13 year olds, experts recommend that, as soon as possible, treatment should take place on an outpatient basis, at an age when separation from the usual environment would be particularly unpleasant and deleterious. However, in severe AN, full-time hospitalisation (FTH) is still indicated when somatic and psychiatric instability criteria are met. Thus, the severity and rapidity of undernutrition in children aged 8-13 years suffering from AN (linked on the one hand to the frequency of total aphagia with refusal to drink and on the other hand to the lack of early detection of the disorder, frequently requires emergency FTH, contrary to expert recommendations. This FTH, which lasts on average 3 months in our specialized unit, has certain disadvantages: poor acceptability by the patient and/or his family, increased anxiety symptoms on entry and exit, school dropout, social isolation, coercive experience. In addition, the rate of premature FTH exits - before weight targets are reached - and the frequency of relapses after FTH remain high, making FTH unsatisfactory in terms of cost-effectiveness. Some families refuse FTH, which is classically long, exposing themselves to the risk of complications that can occur if the disorder is inadequately treated: somatic, acute and chronic complications; risk of progression to another eating disorder. In recent years, day hospitalization (DH) care has been developed for adolescents aged 11 to 18 years and adults (Madden, 2015). The few studies available are in favour of comparable efficacy, better acceptability and lower cost in the management of moderate AN compared to prolonged FTH, but also better social adaptation.In children aged 8 to 13 years with AN, whose somatic condition requires continuous monitoring in a hospital setting (the usual indication for FTH), a DH cannot reasonably be proposed immediately given the severity of the situation. Our hypothesis is that it would however be possible, in these children, to shorten the duration of FTH and to continue DH treatment once the critical period has passed at the somatic level, with comparable efficacy, best acceptability, best progress in terms of school and social integration, and lower cost.

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: NCT04428580 Active, not recruiting - Clinical trials for Online Training for Therapists

Implementing FBT for Adolescent AN for Providers in Private Practice

Start date: November 20, 2020
Phase: N/A
Study type: Interventional

There is a critical need to disseminate efficacious psychosocial treatments for mental disorders as there is a significant gap between evidenced-based approaches and common clinical practice. One example of the need to improve dissemination and implementation of psychosocial treatments is for adolescent Anorexia Nervosa (AN), a serious mental disorder with an incidence rate of about 1% that can become life-threatening. Based on outcomes from a series of randomized clinical trials (RCTs), the first-line treatment for adolescent AN is Family-based Treatment (FBT); however, very few therapists are trained to use FBT for AN. Further, while approximately 45-50% of US mental health outpatient providers are in private practice, little attention has been paid to how best to train this group. Care for adolescent AN, in particular, is provided in private practice at high rates, because specialist programs in non-private settings are few and not readily accessible. Motivations, incentives, and rationale for learning evidence-based treatments (EBTs) differ in this group compared to therapists embedded in an organization or health care system. In this application, we propose to use an online training strategy to study the adoption of FBT to better understand factors that limit or enhance uptake and implementation of this treatment in private practice. We developed and piloted a self-directed enhanced online training (ET-FBT) aimed at improving therapist skills and knowledge related to key components of FBT for AN that predict patient outcome in a group of therapists of which 64% were in private practice. We propose to build on these findings to examine the feasibility of new methods to retain therapists during supervision, assess fidelity, and collect patient outcomes from clinicians in private practice. Thus, our specific aims are: Aim 1: The overall aim of the study is to assess the feasibility of conducting a randomized clinical trial comparing two implementation strategies (online training vs webinar training) for training clinicians in private practice in FBT for AN. We predict that those randomized to online training will be retained, receive supervision, and provide patient data at higher rates than those who receive webinar training. Aim 2: Patient outcomes (reflecting therapist effectiveness) will be assessed by comparing patient weight gain from session 1 to 4 of FBT before and after training (target for training effect) and compared between randomized groups. We predict a moderate efficacy signal difference favoring those who are received the online training. because of increased training in key components in the online training program. Aim 3: Validate training effect by examining the association between therapist fidelity to FBT and patient outcomes. We predict that fidelity will be correlated (target validation) with patient outcome. The effects of therapeutic alliance, participation in supervision, and self-efficacy on both fidelity and patient outcome will be explored. Aim 4: Explore BL factors associated with implementation processes (e.g. prior training, experience, family work).The primary significance of this study is its potential to increase the availability of FBT--the most effective treatment for adolescent AN. Increased availability of FBT will decrease cost, hospitalization, morbidity, mortality, and chronicity of the disorder.

NCT ID: NCT04421989 Completed - Anorexia Nervosa Clinical Trials

Parent Emotion Coaching for Anorexia Nervosa

Start date: June 24, 2020
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT04409704 Completed - Anorexia Nervosa Clinical Trials

Repetitive Transcranial Magnetic Stimulation of the DMPFC for Anorexia and Bulimia: an Open-Label Case Series

Start date: December 11, 2011
Phase: Phase 1
Study type: Interventional

This project proposes to perform a pilot study of fMRI targeted Dorsomedial Prefrontal Cortex repetitive transcranial magnetic stimulation (DMPFC-rTMS) on individuals diagnosed with Bulimia Nervosa (BN) and Anorexia Nervosa (AN). The DMFPC is a novel target for rTMS, is heavily implicated in the regulation of mood and affect, and has been suggested to be involved in AN, BN, major depression, OCD, and PTSD. Improved function in this area might lead to reduced AN and BN symptoms, such as bingeing, purging, and over-activity, perhaps by improved regulation of mood and affect. Improvements in important areas of comorbidity might allow for better response to intensive treatment for AN and BN, and reduce relapse rates after such treatment. The DMPFC may be a more appropriate target for compared to the Dorsolateral Prefrontal Cortex (DLPFC), which has typically been the focus of stimulation in the past. Our initial preliminary pilot work has noted unexpected and significant improvements in some core ED symptoms (bingeing and purging) and in important areas of comorbidity (OCD and PTSD), along with expected improvements in mood. These changes have allowed some treatment resistant patients to either complete intensive treatment or be successful in maintaining their progress post intensive treatment. Subjects will receive up to 30 sessions of bilateral DMPFC-rTMS. Response will be evaluated clinically, via psychometric measures, and pre and post fMRI.

NCT ID: NCT04405440 Recruiting - Anxiety Clinical Trials

Excessive Avoidance Behaviors in Anorexia Nervosa: the Role of Reward

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

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.