PROspective Longitudinal All-comer Inclusion Study in Eating Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Eating Disorder (ICD-10)
Disqualifiers
Forced care/non-voluntary
Trial population
Patients at Psychiatric Center Ballerup with Eating Disorders
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 3 trial groupsGroup A: Patients at Psychiatric Center Ballerup
Group B: Healthy Controls
Group C: Healthy Controls recovered from an eating disorder
Trial outcomes
Primary outcomes
1
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
Time frame
through study completion, an average of 1 year2
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
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
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
Time frame
through study completion, an average of 1 year2
cytokines in plasma
Change in inflammatory parameters in blood as a measure of inflammation status
Time frame
through study completion, an average of 1 year3
Biomarkers in blood
Change in biomarker parameters in blood as a measure of change in biological parameters
Time frame
through study completion, an average of 1 year4
Total score on CogTrac
Change in cognitive performance
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Lead sponsor
University of Southern Denmark
Collaborator
University of Copenhagen
Collaborator
Statens Serum Institut
Collaborator
Source ClinicalTrials.gov