Clinical trial NCT04378101: Eating Disorders Genetics Initiative
Official title: Eating Disorders Genetics Initiative (EDGI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Bulimia Nervosa
Binge-Eating Disorder
Keywords: Anorexia Nervosa
Bulimia Nervosa
Binge-Eating Disorder
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Otago
name: University of Aarhus
name: QIMR Berghofer Medical Research Institute
First posted: 2020-05-07
Enrollment: 17991
Sex: ALL
Minimum age (years): 15
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Interested individuals from the United States, Australia, and New Zealand who meet criteria may participate within their respective country.

Brief summary: The overarching intention of the Eating Disorder Genetics Initiative (EDGI) is to lay the foundation for all future genomic discovery in eating disorders--anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED)--by exploring both genetic and behavioral factors. To do this, information will be collected from 4000 people who have provided DNA samples for the Anorexia Nervosa Genetics Initiative (ANGI) and the same information and DNA will be collected from an additional 16,000 people. The goal is to better understand eating disorders and how they relate to each other so that better treatments can be developed.


Eligibility criteria: Inclusion Criteria:

* A lifetime history of anorexia nervosa, bulimia nervosa, binge-eating disorder, or no history of any disordered eating behavior
* Age 15-99 years

Exclusion Criteria:

* History of subthreshold disordered eating behaviors

Primary outcomes:
measure: Number of Participants Identified with an Eating Disorder Diagnosis by Category
timeFrame: Baseline
measure: Age of eating disorder onset
timeFrame: Baseline
Secondary outcomes:
measure: Current eating disorder self-report total sum scores
timeFrame: Baseline
measure: Eating disorder-related quality of life scores
timeFrame: Baseline
measure: Health-related quality of life scores
timeFrame: Baseline
measure: Current depressive symptoms sum score
timeFrame: Baseline
measure: Prevalence of life-time history of major depression
timeFrame: Baseline
measure: Current anxiety symptoms sum scores
timeFrame: Baseline
measure: Prevalence of generalized anxiety disorder
timeFrame: Baseline
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Brisbane
country: Australia
facility: QIMR Berghofer
state: Queensland
city: Christchurch
country: New Zealand
facility: University of Otago
state: Canterbury
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Cynthia M Bulik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bulik CM, Thornton LM, Parker R, Kennedy H, Baker JH, MacDermod C, Guintivano J, Cleland L, Miller AL, Harper L, Larsen JT, Yilmaz Z, Grove J, Sullivan PF, Petersen LV, Jordan J, Kennedy MA, Martin NG. The Eating Disorders Genetics Initiative (EDGI): study protocol. BMC Psychiatry. 2021 May 4;21(1):234. doi: 10.1186/s12888-021-03212-3.