Clinical Research Directory

Ketamine Effects on Learning In Eating Disorders

This is a single site, single dose clinical trial of intravenous (IV) ketamine for medically hospitalized adolescents and young adults with anorexia nervosa or atypical anorexia nervosa. Eating disorder symptoms will be measured pre- and post-ketamine infusion. Investigators hypothesize that ketamine will increase cognitive flexibility, making medical hospitalizations less distressing by improving the ability to learn new, positive associations with food.

Circuit-Guided Neuromodulation for Anorexia Nervosa

The goal of this clinical trial is to find out whether personalized, non-invasive brain stimulation can temporarily change communication within brain networks related to restrictive eating in adults with anorexia nervosa. The main questions this study aims to answer are: * Does personalized transcranial magnetic stimulation (TMS) change functional connectivity within a brain network related to restrictive eating compared with sham stimulation? * Do different types of TMS affect measures related to inhibitory control, body image, eating-disorder symptoms, mood, and anxiety, and are they safe and well tolerated? Participants will: * Attend four study visits, separated by at least one week. * Complete clinical and psychological assessments and undergo brain magnetic resonance imaging (MRI). * Receive three stimulation conditions in random order at separate visits: intermittent theta-burst stimulation (iTBS), continuous theta-burst stimulation (cTBS), and sham stimulation. * Complete brain MRI scans and research tasks so that the effects of the three stimulation conditions can be compared. Researchers will compare the effects of iTBS and cTBS with sham stimulation on brain connectivity and other study measures. This is an exploratory proof-of-concept study designed to test whether personalized brain stimulation can engage the targeted brain circuit. It is not designed to determine whether TMS is an effective treatment for anorexia nervosa, and direct clinical benefit to participants is not expected.

Incorporating Narrative Into the Treatment of Youth With Anorexia Nervosa (Virtual)

The goal of this clinical trial is to evaluate whether a narrative medicine (NM) curriculum can enhance self-expression, reflection, and resilience in adolescents and young adults with anorexia nervosa. The main questions it aims to answer are: * Does participation in an NM curriculum improve self-expression and reflection in individuals with anorexia nervosa? * Does engaging in creative writing and group discussion promote resilience and emotional processing in this population? Participants will be 16-25 years old, medically stable for outpatient eating disorder therapy, and actively engaged in treatment. Those with active suicidal ideation, recent non-suicidal self-injury, or a co-occurring personality disorder will not be eligible. Participants will: * Attend six weekly workshops focused on themes such as self-definition, kindness, resilience, and possibility * Engage in close reading of visual or written texts * Complete creative writing exercises in response to prompts * Participate in group discussions and sharing An optional capstone reading event will provide a supportive space for participants to share their work with peers, loved ones, and providers, fostering connection and community. This study aims to explore the role of narrative medicine in eating disorder treatment and assess its potential benefits for psychological well-being and self-expression.

Exposure Therapy Study In Adults With Eating Disorders

The current proposal will evaluate the feasibility, acceptability, and preliminary efficacy of Exposure Therapy for anorexia nervosa (AN) spectrum disorders (Exp-AN), an innovative treatment rooted in principles of inhibitory learning. Exp-AN will target anxiety about both eating and weight gain by combining in vivo (i.e., in real life) and imaginal (i.e., mental) exposure in novel ways (e.g., eating a feared food while listening to a recording describing fears about weight gain).

Open vs. Blind Weighing Study In Adolescents and Young Adult With Eating Disorders

Current treatments for adolescents and young adults (AYAs) with eating disorders (EDs) do not effectively address a central ED symptom - anxiety about weight gain - which contributes to poor outcomes. The proposed study evaluates the feasibility, acceptability, efficacy, and underlying mechanisms of an enhanced version of "open weighing," a cognitive-behavioral intervention designed to target anxiety about weight gain in AYAs with EDs. Understanding how to better treat AYAs with EDs, and identifying the mechanisms by which interventions lead to improvement, will aid in the development of more effective and personalized treatments, ultimately improving the lives of AYAs with EDs.

Reestablishing Normal Gut-brain Interaction in Anorexia Nervose With Normal Gut Microbiota

In this pilot study 36 patients with anorexia nervosa (AN) will be randomized to either treatment with psychotherapy as usual (TAU) or TAU plus fecal microbiota transplantation (FMT). The transplantation will be performed when refeeding has started. Patients randomized to TAU+FMT will choose either capsules or gastroscopy as source of FMT. One week after FMT gut microbiota will be collected and analyzed and compared with microbiota composition at baseline. The two groups are then followed during psychotherapy to assess whether it is feasible to give FMT during psychotherapy to study the effects on outcome. In addition, this pilot study is aiming at paving the way for performing larger studies to assess whether FMT improves outcome from psychotherapy when given in combination with psychotherapy in patients with AN.

Impact of Fatty Stimuli on Cerebral Activity in Anorexia Nervosa: a Multi-sensory Approach

Lipid restriction is significant in anorexia nervosa and limits therapeutic management. The multisensory perception of fat is altered, creating an aversion to lipids. The investigators aim to characterize the impact of sensory stimulation (smells or images) associated with specific tastes using neuropsychological assessments and functional MRI. Some volatile aromas can enhance the perception of the associated taste. The investigators hypothesize that such associations are altered in anorexia nervosa for fatty foods but may be preserved for sweet tastes, and that this alteration contributes to the maintenance of the disease. The interdependence of different sensory perceptions of lipids could play a major role in the therapeutic approach, aiding in the deconditioning of this aversion and the restoration of positive food sensory associations.

Impairment of Central Coherence in Restrictive Anorexia Nervosa (CoCA)

The current etiological pathological model of anorexia nervosa is poly-factorial involving individual genetic and psychological factors, in close interaction with environmental, family and socio-cultural factors. Among these factors, this study focuses on the central coherence process (cognitive ability to integrate complex information into a comprehensive meaning), in the active phase of the disease. Therefore, patients followed in the addiction service of the Nantes University Hospital will perform neuropsychological tests assessing executive functions involved in the process of central coherence. Impairment of central coherence process could act as a maintenance factor of the disease, particularly in connection with body dysmorphic disorder. The therapeutic perspectives acting on the central coherence process like cognitive remediation deserve to deepen knowledge on the cognitive profile of patients with anorexia nervosa.

Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders

This project includes a 4-week randomized trial comparing pre-meal vagal nerve stimulation (taVNS) to pre-meal sham stimulation. The aims will assess if taVNS results in greater satisfaction, greater calorie consumption, less self-reported fullness, decrease in eating disorder symptoms, and less anxiety than sham stimulation.

Neural Correlates of Autistic Individuals With Anorexia Nervosa

Masking is a behaviour or strategy used by many Autistic people to appear non-Autistic and blend in with a neurotypical society. The goal of this observational study is to understand the relationship between masking, anorexia nervosa symptoms and brain structure in Autistic people. The main questions this study aims to answer are: * Do Autistic individuals with anorexia nervosa show differences in structure or function of the brain relation to Autistic individuals without anorexia nervosa? * Do Autistic individuals with anorexia nervosa display higher levels of masking than Autistic individuals without anorexia nervosa? * Are there indeed relationships between levels of masking, anorexia nervosa symptoms and brain structure in Autistic people? Researchers will compare Autistic people without anorexia nervosa to Autistic people with anorexia nervosa to see if there are differences between groups. Participants will: * Complete a series of questionnaires focused on eating disorder symptoms, autistic traits, autistic masking and psychological well-being * Undergo an MRI scan at the Aberdeen Royal Infirmary

Facing Eating Disorder Fears for Anorexia Nervosa

FED-F is a modular treatment that enhances exposure therapy with psychoeducation and cognitive skills teaching how to face fears of (a) food, (b) weight gain, (c) interoception/body, and (d) social situations. The study goals are to (1) refine and test the acceptability and feasibility of FED-F treatment (Phase I), (2) test if this treatment outperforms treatment as usual (TAU) delivered post-acute treatment as adjunctive to stepdown specialty care (Phase II), and (3) to examine if treatment targets the hypothesized mechanism of action: approach behaviors (Phase II). These goals will lead to a highly deployable and accessible virtual treatment targeted at core AN mechanisms that predict relapse. Specific aims are to (1) refine FED-F into a fully virtual format with input from patients and stakeholders and collect preliminary data (N=10) on its feasibility and acceptability (Phase I), (2) conduct a small pilot RCT (randomized controlled trial) of FED-F (n=30) as compared to TAU (n=30; Phase II), and (3) examine if FED-F targets approach/avoidance behaviors and test if this mechanism is associated with clinical outcomes (Phase II).

Frequency of Hypermobility-Related Problems in Patients With Anorexia Nervosa

The purpose of this study is to examine the frequense of generalized hypermobility and pain in patients with Anorexia Nervosa. The study further explores two main questions: (1) whether generalized hypermobility may be an explanatory factor for pain in some patients with Anorexia Nervosa, and (2) whether temporomandibular joint problems (such as instability, pain, difficulties opening the mouth, locking, or clicking) contribute to eating difficulties in certain individuals with Anorexia Nervosa.

Online FBT-DBT Caregiver Intervention for Caregivers of Individuals With Anorexia Nervosa

Anorexia nervosa (AN) is a severe psychiatric disorder characterized by a chronic and relapsing course. Caregivers of individuals with AN often experience substantial caregiving burden, emotional distress, and impairment in family functioning due to their ongoing responsibilities in meal supervision, treatment support, and symptom management. Despite the critical role of caregivers in treatment and recovery, evidence-based interventions specifically targeting caregiver burden remain limited in China. This study aims to develop and evaluate an online intervention integrating Family-Based Treatment (FBT) and Dialectical Behavior Therapy (DBT) for caregivers of individuals with AN. FBT emphasizes empowering caregivers to support nutritional rehabilitation and recovery, whereas DBT provides skills in emotion regulation, validation, and effective communication. The integration of these approaches may help caregivers reduce distress, improve caregiving skills, and enhance family functioning. This study will employ a randomized controlled trial design. A total of 80 primary caregivers of individuals with AN will be recruited and randomly assigned to either an online FBT-DBT intervention group or an online supportive psychological intervention group. Both interventions will be delivered in a group format over 12 weeks. Assessments will be conducted at baseline, 4 weeks, 8 weeks, post-intervention (12 weeks), and at 1-month and 3-month follow-up. The primary outcome will be caregiver burden. Secondary outcomes will include psychological distress, negative emotional experiences, and the impact of eating disorder symptoms on the family. The study aims to determine the effectiveness of the online FBT-DBT intervention in reducing caregiver burden and psychological distress and to evaluate whether it provides greater benefits than supportive psychological intervention. Findings may contribute to the development of accessible and evidence-based caregiver interventions for families affected by AN in China.

Investigation of Multi-Family Therapy for Anorexia Nervosa

The proposed project is an intensive multi family therapy (MFT) intervention involving patients with anorexia nervosa and their families. MFT interventions are informed from the principles of the family based treatment (FBT)/family therapy for Anorexia Nervosa (FT-AN) models. This program will offer families in vivo/virtual support while connecting with other families to increase knowledge of eating disorders and develop skills related to successfully supporting their adolescent during difficult times, including meal support and affect regulation. Our objective is to explore the influence of the MFT intervention on the primary outcome measures in eating disorder treatment, including weight, expressed emotion and eating disorder symptomatology.

Safety, Therapeutic Potential, and Mechanisms of Two Psilocybin Doses, Administered With Psychological Support in Young Adults With Anorexia Nervosa

The goal of this clinical trial is to learn if psilocybin, given with psychological support, is safe and helps treat anorexia nervosa in young adults. Anorexia nervosa is a serious eating disorder that currently has no approved medicine. Psilocybin is a psychedelic substance that may help the brain form new connections, which could make it easier for people with anorexia nervosa to develop healthier ways of thinking. The main questions this study aims to answer are: * Is psilocybin with psychological support safe and well-tolerated? * Does psilocybin with psychological support help lower symptoms of anorexia nervosa? * How might psilocybin work in the brain to support recovery from anorexia? This study will compare psilocybin with psychological support to Treatment as Usual (TAU). Participants in the study will be randomly placed into one of the two groups. There will be 40 patients with anorexia nervosa included, 20 per group. TAU includes the standard care people receive for anorexia nervosa in a specialized eating disorder clinic in Region Skåne, Sweden. Participants will: * Be between 16 and 35 years old and have anorexia nervosa * Take psilocybin (25 mg) by mouth two times, four weeks apart * Receive psychological support before, during, and after each dosing session (including preparation and integration sessions) * Complete questionnaires, have brain scans (magnetic resonance imaging) and blood tests to learn more about how psilocybin may work * Share their personal experiences as part of a qualitative interview This study hopes to learn if psilocybin, when given with the right support, can be a helpful and safe option for people living with anorexia nervosa.

Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa

The investigators will recruit individuals with broadly-defined AN (n = 80) who are currently in or have recently participated in higher-level eating disorder treatment (e.g., residential, partial hospitalization/day treatment, intensive outpatient treatment). Interested participants will sign consent, complete eligibility assessments, and will be randomized to receive Positive Affect Treatment for Anorexia Nervosa (PAT-AN) or Psychoeducation and Behavioral Therapy (PBT) through teletherapy shortly following discharge from higher level of care. Participants can participate in most other forms of outpatient treatment while receiving the research intervention. Participants will engage in 24 weeks of PAT-AN or PBT starting in the first 3 months post-discharge. At each session, the investigators will complete brief measures assessing treatment acceptability, affect, and eating disorder symptoms. Participants will also complete an assessment battery of self-report, EMA, and neurocognitive measures evaluating primary outcomes (BMI; eating disorder symptoms), secondary outcomes (depression, anxiety, and suicidality), and presumed treatment mechanisms at baseline, end of treatment (EOT), and 3-month follow-up (FU). All assessments will be remotely delivered via HIPAA-compliant platforms.

A Group Intervention for Parents of Autistic Young People With Anorexia Nervosa: An Exploration of How Parents Make Sense of and Integrate Concepts From the Group Into Family Life

The goal of this study is to understand how a group intervention for parents of autistic young people with co-occurring anorexia nervosa informs how parents support their child's recovery. The main questions it aims to answer are: 1. How do parents interpret and understand the concepts learnt in the group intervention? How do parents apply this to day to day family life? 2. How do parents understand how autism impacts their child's recovery from anorexia nervosa? 3. How do parents make sense of their role in supporting their child's recovery? Participants will be invited to take part in an interview about their experience of attending the group intervention and applying the concepts to their family life.

Patient-derived Stem Cell Models of Anorexia Nervosa

Experimental and genetic data, as well as brain imaging, support a role of the hypothalamic Arcuate nucleus neurons and their communication with surrounding microglia in anorectic conditions, but it has until recently not been possible to explore these cells at a molecular level in anorexia nervosa (AN) patients. This attributed to the obvious lack of valid tissue and non-invasive imaging techniques of high enough resolution. Stem cell models have evolved as a useful tool for the exploration of other neuropsychiatric disorders with a comparably high genetic contribution as AN. The investigators will here use patient-derived induced pluripotent stem cells (iPSCs) to profile Arc neurons and peripheral blood mononuclear cell (PBMC) derived microglia in AN, thus defining molecules to explore as drug targets.

Developing an EEG Paradigm to Study Prediction Error in Anorexia Nervosa

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.

Therapeutic Ketogenic Diet in Partial Hospital Program (PHP) Anorexia Nervosa

This will be a 14-week longitudinal study with an open design. A total of 120 individuals will be recruited for an end goal of 60 individuals with anorexia nervosa (AN) who are currently in high level of care treatment at the UCSD Eating Disorder Center partial hospital program (PHP) or intensive outpatient (IOP). Forty individuals will be recruited to the TKD and 20 will be treated with treatment as usual with respect to food intake. The age range will be between 16 and 45 years. All study participants will be carefully assessed and will complete rater and self-assessments at the being at the end of the study period. While in the treatment program, the TKD group will receive catered ketogenic meals via a meal service. After discharging from program, participants will have the option to continue with the meal service or cook for themselves. After establishing ketosis, study participants will continue TKD for 12 weeks. All study participants will be followed over three, six, and twelve months after enrolling in the study, whether initiating TKD or being in the treatment as usual arm. This follow-up procedure will help determine whether symptom improvement is stable or worsens in individuals who choose to continue or discontinue the TKD intervention and in relation to the control group. After ketosis induction over two weeks, study participants will be assessed weekly for ketosis and mood, anxiety, and eating disorder symptoms over twelve weeks.

Ketone Supplementation in Eating Disorders

This study will investigate the effects of ketone supplementation on eating behavior including drive to binge eat or restrict, mood and anxiety in individuals with anorexia or bulimia nervosa. In addition, the investigators will contrast the effects of active ketone supplementation versus placebo on electroencephalogram (EEG) measurement. All subjects enrolled in the study will undergo EEG on two consecutive days at the beginning of the study, after active ketone supplementation or placebo drink, matched in taste to the ketone drink. Days will be randomized. Thereafter, all subjects will take the ketone supplementation drink for two weeks, twice daily.

Transcranial Magnetic Stimulation (TMS) in the Treatment of Anorexia Nervosa

Anorexia nervosa is a severe psychiatric disorder associated with food avoidance and body image distortion, that is feeling fat despite being underweight. It is the third most common chronic illness among adolescent females, and its mortality reaches its peak between the ages 16 and 29 years old. There are very few treatments for anorexia nervosa and especially no biological treatments have been approved. Recent brain imaging research has repeatedly implicated brain circuits that include the insula in the disorder. The insula is a brain region important in taste processing as well as in the integration of body perception and has strong connections to the brain reward system. Transcranial magnetic stimulation (TMS) is a relatively new methodology that has been shown to alter neurocircuitry and alleviate depression. Here, the study goal is to develop TMS as a methodology to change altered neurocircuitry in anorexia nervosa and alleviate disorder specific behaviors.

An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa

The purpose of this study is to test the feasibility and tolerability of donepezil in a small group of patients with anorexia nervosa (AN). Study participants will be receiving care at the New York State Psychiatric Institute Eating Disorders Unit. Study medication will be increased from 1 mg per day to a maximum of 5 mg per day for up to 8 weeks. Participants will be closely monitored for side effects by a research psychiatrist every week, in addition to the regular clinical monitoring they receive during inpatient treatment. The study will also include assessments of habit strength to measure any changes in maladaptive eating habits over the course of the treatment.

Evaluation of a Twenty-session Cognitive-behavioral Therapy With Anorexia Nervosa (CBT-20-AN) Among Adults (18+)

The study is a clinical trial assessing the efficacy of a new twenty session cognitive behavioral therapy for adults (18+) with anorexia nervosa (AN) and atypical anorexia nervosa. It is expected that participants will gain a significant amount of weight and experience a significant decrease in eating disorder psychopathology and behavior from pre- to post- treatment and that this will be retained after 6-months.