PROspective Longitudinal All-comer Inclusion Study in Eating Disorders

Anorexia Nervosa Clinical Trial

— PROLED  

Official title:

PROspective Longitudinal All-comer Inclusion Study in Eating Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03224091
• Other study ID #: PCB-BCRED-1
• Status: Recruiting
• Start date: January 25, 2016
• Est. completion date: April 1, 2030

Study information

• Verified date: April 2022
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Magnus JC Sjögren, MD, PhD
• Phone: +4538645157
• Email: jan.magnus.sjoegren[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 1, 2030
• Est. primary completion date: April 1, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Eating Disorder (ICD-10)

Exclusion Criteria:

• Forced care/non-voluntary

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Denmark	Mental Health Center	Ballerup	Capitol Region

Sponsors (4)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Statens Serum Institut, University of Copenhagen, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	cytokines in plasma	Change in inflammatory parameters in blood as a measure of inflammation status	through study completion, an average of 1 year
Secondary	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
Secondary	Total score on CogTrac	Change in cognitive performance	through study completion, an average of 1 year
Secondary	Change in EDI	Change in Eating disorder related behaviour and symptoms	through study completion, an average of 1 year