NCT03224091|Recruiting
PROspective Longitudinal All-comer Inclusion Study in Eating Disorders
PROLED
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PROLED
Sponsor study identifier
observational
1,000
1 country
1
Study Start
January 25, 2016
Actual (reported)Primary Completion
April 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 25, 2016
Actual (reported)March 23, 2017
Actual (reported)July 21, 2017
Actual (reported)April 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
MDI
through study completion, an average of 1 year
Patients at Psychiatric Center Ballerup with Eating Disorders
Mental Health Center
Ballerup Municipality, Capitol Region, 2750, Denmark
Louise Behrend_Rasmussen, MD,PhD
Mental Health Center Ballerup
First Submitted
March 23, 2017
First Posted
July 21, 2017
Study Start
January 25, 2016
Actual (reported)Primary Completion
April 1, 2030
EstimatedCognitive Training for Patients With Eating Disorders
cytokines in plasma
through study completion, an average of 1 year
Biomarkers in blood
through study completion, an average of 1 year
Total score on CogTrac
through study completion, an average of 1 year
Change in EDI
through study completion, an average of 1 year
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 7, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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