PROspective Longitudinal All-comer Inclusion Study in Eat... | NCT03224091

Studies
PROspective Longitudinal All-comer Inclusion Study in Eating Disorders

NCT03224091

Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Status

Recruiting

Last Update Posted

Apr 7, 2022Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Anorexia Nervosa
Bulimia Nervosa
Binge-Eating Disorder
Eating Disorder NOS

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2016Actual

Primary Completion Date

Apr 1, 2030Estimated

Completion Date

Apr 1, 2030Estimated

First Submitted Date

Mar 23, 2017

First Submission Date that Met QC Criteria

Jul 18, 2017

First Posted Date

Jul 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2022

Last Update Posted Date

Apr 7, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jan Magnus Sjögren, Research Associate Professor, Sr Consultant Psychiatrist, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalPrincipal Investigator

Lead Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalOTHER

Collaborators

Name	Class
University of Southern Denmark	OTHER
University of Copenhagen	OTHER
Statens Serum Institut	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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
cytokines in plasma

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eating Disorder (ICD-10)

Exclusion Criteria:

Forced care/non-voluntary

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients at Psychiatric Center Ballerup with Eating Disorders

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Magnus JC Sjögren, MD, PhD	Contact	+4538645157		jan.magnus.sjoegren@regionh.dk

Overall Officials

Name	Affiliation	Role
Louise Behrend_Rasmussen, MD,PhD	Mental Health Center Ballerup	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mental Health Center	Recruiting	Ballerup Municipality	Capitol Region	2750	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000856	Anorexia Nervosa
D052018	Bulimia Nervosa
D056912	Binge-Eating Disorder
D001068	Feeding and Eating Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Patients at Psychiatric Center Ballerup
Healthy Controls
Healthy Controls recovered from an eating disorder