Clinical trial NCT03224091: PROspective Longitudinal All-comer Inclusion Study in Eating Disorders
Official title: PROspective Longitudinal All-comer Inclusion Study in Eating Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia Nervosa
Bulimia Nervosa
Binge-Eating Disorder
Eating Disorder NOS
Keywords: Eating disorders
psychopathology
pathophysiology
prospective
longitudinal
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: University of Copenhagen
name: Statens Serum Institut
First posted: 2017-07-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at Psychiatric Center Ballerup with Eating Disorders

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Eating Disorder (ICD-10)

Exclusion Criteria:

* Forced care/non-voluntary

Primary outcomes:
measure: GAF-F total score
timeFrame: through study completion, an average of 1 year
measure: BMI change over time
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: MDI
timeFrame: through study completion, an average of 1 year
measure: cytokines in plasma
timeFrame: through study completion, an average of 1 year
measure: Biomarkers in blood
timeFrame: through study completion, an average of 1 year
measure: Total score on CogTrac
timeFrame: through study completion, an average of 1 year
measure: Change in EDI
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ballerup
country: Denmark
facility: Mental Health Center
state: Capitol Region
Study officials:
affiliation: Mental Health Center Ballerup
name: Louise Behrend_Rasmussen, MD,PhD
role: STUDY_CHAIR
References: