PROspective Longitudinal All-comer Inclusion Study in Eating Disorders

Study Overview
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Brief Summary
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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.

Detailed Description
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The objective is to increase the understanding of the psychopathology and pathophysiology of Eating Disorders. More specifically, the aim is to identify biomarkers that relate to prognosis, disease course and response to treatment as usual of Eating Disorders, and, to improve the understanding of the pathophysiology of Eating disorders in order to identify novel molecular targets for treatment. Rationale The etiology of Eating Disorders (ED's) is unknown. Previous studies have identified genes that link Anorexia Nervosa to other psychiatric (e.g. schizophrenia) and somatic disorders (e.e. diabetes). Association studies have also suggested genetic causes underlying Bulimia Nervosa and Binge Eating Disorders. The PROLED study aims to improve the understanding of both the psychopathology and pathophysiology of Eating Disorders. No experimental drug will be used in this study. There is a great need for an increased biological understanding of ED's in view of the prevalence, the costs, the severity and high mortality rates, and the lack of efficient treatments. The PROLED study aims to answer questions related to these unmet medical needs. The study design is prospective and longitudinal. Qualitative interviews, psychometric tests, questionnaires are used to collect data on psychopathology. There is also collection of blood, urine and faeces.

Official Title
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PROspective Longitudinal All-comer Inclusion Study in Eating Disorders

Conditions
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Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Eating Disorder NOS

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eating Disorder (ICD-10) Exclusion Criteria: Forced care/non-voluntary

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients at Psychiatric Center Ballerup<br> | |
| Healthy Controls<br> | |
| Healthy Controls recovered from an eating disorder<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GAF-F total score | Change in Global level of functioning will be assessed using the GAF-F score for the whole population of treated individuals | through study completion, an average of 1 year | 
| BMI change over time | Change in Body Mass Index (BMI) will be assess in the whole population of Anorexia Nervosa patients and compared to other diagnoses and Healthy controls, change over time | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDI | Change in Major Depressive Inventory will be used to assess depressiveness, assessed for all patients with one diagnosis and compared to other diagnoses and healthy controls; change over time | through study completion, an average of 1 year | 
| cytokines in plasma | Change in inflammatory parameters in blood as a measure of inflammation status | through study completion, an average of 1 year | 
| Biomarkers in blood | Change in biomarker parameters in blood as a measure of change in biological parameters | through study completion, an average of 1 year | 
| Total score on CogTrac | Change in cognitive performance | through study completion, an average of 1 year | 
| Change in EDI | Change in Eating disorder related behaviour and symptoms | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eating disorders, psychopathology, pathophysiology, prospective, longitudinal