Eating Disorders Genetics Initiative 2

NCT ID: NCT06594913

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-28

Study Completion Date

2027-08-01

Brief Summary

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The overarching intention of the Eating Disorder Genetics Initiative 2 (EDGI2) is to increase sample size, diversity, and eating disorder phenotypes. The investigators are enrolling 20,000 new participants with anorexia nervosa (AN), bulimia nervosa (BN), binge-eating disorder (BED), avoidant/restrictive food intake disorder (ARFID), and controls in the US, Mexico, Australia, New Zealand, Sweden, and Denmark. A primary study goal is to enroll at least 30% of participants from underrepresented groups. Participants are asked to complete a series of questionnaires and submit a saliva sample for genotyping. The goal is to better understand eating disorders and how they relate to each other so that better treatments can be developed.

Detailed Description

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Conditions

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Anorexia Nervosa Bulimia Nervosa Binge-Eating Disorder Avoidant Restrictive Food Intake Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Anorexia nervosa

Individuals with a self-reported lifetime history of anorexia nervosa.

Eating disorder diagnosis group

Intervention Type OTHER

This is an observational study, no active intervention is applied. Participants are assigned to an eating disorder diagnosis group based on their lifetime history of disordered eating behaviors and symptoms.

Bulimia nervosa

Individuals with a self-reported lifetime history of bulimia nervosa.

Eating disorder diagnosis group

Intervention Type OTHER

This is an observational study, no active intervention is applied. Participants are assigned to an eating disorder diagnosis group based on their lifetime history of disordered eating behaviors and symptoms.

Binge-eating disorder

Individuals with a self-reported lifetime history of binge-eating disorder.

Eating disorder diagnosis group

Intervention Type OTHER

This is an observational study, no active intervention is applied. Participants are assigned to an eating disorder diagnosis group based on their lifetime history of disordered eating behaviors and symptoms.

ARFID

Individuals with a self-reported lifetime history of avoidant restrictive food intake disorder.

Eating disorder diagnosis group

Intervention Type OTHER

This is an observational study, no active intervention is applied. Participants are assigned to an eating disorder diagnosis group based on their lifetime history of disordered eating behaviors and symptoms.

Control

Individuals with no history of disordered eating behaviors or symptoms

Eating disorder diagnosis group

Intervention Type OTHER

This is an observational study, no active intervention is applied. Participants are assigned to an eating disorder diagnosis group based on their lifetime history of disordered eating behaviors and symptoms.

Interventions

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Eating disorder diagnosis group

This is an observational study, no active intervention is applied. Participants are assigned to an eating disorder diagnosis group based on their lifetime history of disordered eating behaviors and symptoms.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A lifetime history of anorexia nervosa, bulimia nervosa, binge-eating disorder, avoidant restrictive food intake disorders or no history of any disordered eating behavior, based on DSM-5 criteria algorithms
* Age 12-99 years, depending on country. (US enrollment age is 18-99)

Exclusion Criteria

* History of subthreshold disordered eating behaviors.
Minimum Eligible Age

12 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queensland Institute of Medical Research

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Otago

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

Comenzar de Nuevo, AC

OTHER

Sponsor Role collaborator

University of Sydney

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cynthia Bulik, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status RECRUITING

QIMR Berghofer

Brisbane, Queensland, Australia

Site Status RECRUITING

Comenzar de Nuevo

Monterrey, , Mexico

Site Status RECRUITING

University of Otago

Christchurch, Canterbury, New Zealand

Site Status RECRUITING

Karolinska Institutet

Stockholm, , Sweden

Site Status RECRUITING

Countries

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United States Australia Mexico New Zealand Sweden

Central Contacts

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Laura M Thornton, PhD

Role: CONTACT

804-690-3079

Casey MacDermod, BA

Role: CONTACT

984-974-3798

Facility Contacts

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Laura M Thornton, PhD

Role: primary

804-690-3079

Richard Parker

Role: primary

Anid Cortes Morales

Role: primary

Jennifer Jordan

Role: primary

Lisa Dinkler, PhD

Role: primary

References

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Berthold N, MacDermod CM, Thornton LM, Parker R, Morales SAC, Hog L, Kennedy HL, Guintivano J, Sullivan PF, Crowley JJ, Johnson JS, Birgegard A, Fundin BT, Frans E, Xu J, Ngati Pukenga MP, Miller AL, Aguilar MV, Barakat S, Abdulkadir M, White JP, Larsen JT, Trujillo E, Winterman B, Zhang R, Lawson R, Wonderlich S, Wonderlich J, Schaefer LM, Mehler PS, Oakes J, Foster M, Gaudiani J, Vacuan ETC, Compte EJ, Petersen LV, Yilmaz Z, Micali N, Jordan J, Kennedy MA, Maguire S, Huckins LM, Lu Y, Dinkler L, Martin NG, Bulik CM. The Eating Disorders Genetics Initiative 2 (EDGI2): study protocol. BMC Psychiatry. 2025 May 26;25(1):532. doi: 10.1186/s12888-025-06777-5.

Reference Type DERIVED
PMID: 40419993 (View on PubMed)

Other Identifiers

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R01MH136149

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MH136157

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MH136156

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-2887

Identifier Type: -

Identifier Source: org_study_id

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