Anorexia Nervosa Clinical Trial
— ESTRA-BEDOfficial title:
Multimodal Longitudinal and Machine Learning-based Predictive Modelling to Understand the Development of Eating Disorders
The aim of this observational study is to elucidate the biopsychosocial (including neural, psychological, and social) basis of eating disorders (EDs). The investigators will use functional and structural neuroimaging, psychological as well as environmental data to identify both shared and distinct behavioural/neural processes across ED diagnoses. The investigators will use advanced statistical methods such as machine learning based models. The investigators will carry out analysis on the data already collected in the STRATIFY (Brain network based stratification of reinforcement-related disorders, IRAS ID 218030) and IMAGEN studies (Reinforcement-related behaviour in normal brain function and psychopathology, reference PNM/10/11-126), including participants with Anorexia Nervosa (N=60), Bulimia Nervosa (N=52), Binge eating disorder (N=27) and healthy controls. In addition, the investigators will recruit 30 new participants with a binge eating disorder using the original STRATIFY study protocol to enlarge the binge eating disorder group, so that its sample size is comparable to the other groups. Participants will complete online questionnaires, take an online clinical interview, and undergo a research visit, including brain scans, collection of blood and urine samples, and assessment using a range of cognitive and behavioural measures.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: - Male and female volunteers, all ethnicities. - Age of 18 to 30. - Sufficient in English (due to validity of neuropsychological measures). - current DSM-5 binge eating disorder. Exclusion Criteria: - People with brain injuries including stroke, tumours, epilepsy, neurodegenerative or other neurological disorders. - People who are deaf or have significant hearing problems or a hearing aid that cannot be removed. - People who are blind or have significant vision difficulties (correct near vision of 20/100 or worse in both eyes). - People with type I or type II diabetes. - People who are heavily medicated for serious illness (other than for mental illness). - People who are pregnant or any possibility of being pregnant. - People with restricted mobility, including inability to lie flat for 1.5 hours. - People who have a history of anorexia nervosa and have not restored their body weight in the past 6 months. - People who have participated in the STRATIFY, ESTRA or IMAGEN studies previously. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Institute of Psychiatry, Psychology & Neuroscience, King's College London | London |
Lead Sponsor | Collaborator |
---|---|
King's College London | Delosis Limited, NeuroSpin |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Eating disorder diagnosis | The Eating Disorder Diagnostic Scale (DSM-5 version) will be used to assess whether the participants meet the diagnostic criteria of anorexia nervosa, bulimia nervosa, or binge eating disorder. | Administered at the screening phase and within two weeks of the other assessments. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05531604 -
Appetitive Conditioning in Anorexia Nervosa
|
||
Enrolling by invitation |
NCT04174703 -
Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing
|
N/A | |
Active, not recruiting |
NCT04883554 -
Impact of an Olfactory Sensory Therapeutic Group for Adolescent Patients With Restrictive Anorexia Nervosa , Pilot Study
|
N/A | |
Recruiting |
NCT04213820 -
TMS and Body Image Treatment for Anorexia Nervosa
|
N/A | |
Completed |
NCT03414112 -
The Impact of Oxytocin on the Neurobiology of Anorexia Nervosa
|
Early Phase 1 | |
Recruiting |
NCT06144905 -
Norwegian Microbiota Study in Anorexia Nervosa
|
||
Recruiting |
NCT05803707 -
Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study
|
N/A | |
Recruiting |
NCT05682417 -
Impact of Body Schema Distortion on Remission and Weight Regain in Anorexia Nervosa
|
N/A | |
Not yet recruiting |
NCT06380257 -
Anorexia Nervosa and Brain in Adolescence
|
||
Not yet recruiting |
NCT04804800 -
Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa
|
N/A | |
Not yet recruiting |
NCT03600610 -
Evaluation of CARdiac Abnormalities by Echocardiography and MRI in Malnourished Patients Suffering From Anorexia Nervosa
|
N/A | |
Completed |
NCT02745067 -
Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa
|
N/A | |
Completed |
NCT02382055 -
Changing Habits in Anorexia Nervosa: Novel Treatment Development
|
N/A | |
Terminated |
NCT02240797 -
Kappa Opioid Receptor Imaging in Anorexia
|
N/A | |
Completed |
NCT03075371 -
Homeostatic and Non-homeostatic Processing of Food Cues in Anorexia Nervosa
|
N/A | |
Completed |
NCT03144986 -
Insula-coil Deep TMS for Treatment Resistant Anorexia Nervosa
|
N/A | |
Unknown status |
NCT01761942 -
Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa
|
Phase 2 | |
Completed |
NCT02551445 -
A fMRI Pilot Study of the Effects of Meal-support in Eating Disorders.
|
N/A | |
Completed |
NCT01579682 -
Adaptive Family Treatment for Adolescent Anorexia Nervosa
|
N/A | |
Completed |
NCT00946816 -
The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity
|
N/A |