PROspective Longitudinal All-comer Inclusion Study in Eating Disorders — PROLED  

Anorexia Nervosa Clinical Trial

Official title: PROspective Longitudinal All-comer Inclusion Study in Eating Disorders

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Disease
• Eating Disorder NOS
• Feeding and Eating Disorders

• NCT number: NCT03224091
• Study type: Observational
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Magnus JC Sjögren, MD, PhD
• Phone: +4538645157
• Email: jan.magnus.sjoegren@regionh.dk
• Status: Recruiting
• Start date: January 25, 2016
• Completion date: April 1, 2030