A Neurocomputational Assay of Gastrointestinal Interoception in Anorexia Nervosa

Laureate Institute for Brain Research, Inc.1 site in 1 country150 target enrollmentDecember 1, 2021

ConditionsAnorexia Nervosa

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anorexia Nervosa
Sponsor: Laureate Institute for Brain Research, Inc.
Enrollment: 150
Locations: 1
Primary Endpoint: Interoceptive prior
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Anorexia nervosa (AN) has among the highest mortality rate of any psychiatric illness, yet we have a poor understanding of the biological causes of this disorder. In this study, we use a novel mechanosensory intervention to examine the basic question of whether individuals with AN have abnormal "gut sensations" and whether such indicators are associated with adverse consequences from the disorder.

Registry

clinicaltrials.gov

Start Date

December 1, 2021

End Date

July 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Laureate Institute for Brain Research, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•HC Inclusion criteria:
•i. Body mass index ≥ 18.
•ii. Females, ages 15 to 40 years iii. Women of childbearing age: a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study.
•iv. Independently ambulatory v. Possession of a smartphone with data plan vi. English proficiency vii. Willingness and ability to participate in study procedures viii. Provision of signed and dated informed consent form
•AN Inclusion criteria:
•i. Primary clinical diagnosis of anorexia nervosa as defined by Laureate Eating Disorders Program ii. Body mass index ≥ 18.
•iii. Transitioned from acute clinical status rating to residential clinical status or partial/intensive outpatient clinical status rating iv. No new medication prescription in the week prior to study randomization, Must be on a stable dose of medication for at least 1 week.
•v. Females, ages 15 to 40 years vi. Women of childbearing age: a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study.
•vii. Independently ambulatory viii. Possession of a smartphone with data plan ix. English proficiency x. Willingness and ability to participate in study procedures xi. Provision of signed and dated informed consent form

Exclusion Criteria

•HC Exclusion criteria:
•i. Current diagnosis of a psychiatric disorder per the MINI International Diagnostic Interview
•ii. Taking any psychotropic medication
•iii. Active suicidal ideation with intent or plan
•iv. Active cutting or skin lacerating behaviors
•v. Active purging behaviors (specifically, self-induced vomiting), and/or a history of severe self-induced vomiting
•vi. Pregnancy as defined by a urine screen during screening, and confirmed during each stimulation visit, and must not be lactating
•vii. History of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if the subject has been treated and is in remission)
•viii. History of complicated/obstructive diverticular disease
•ix. Clinical evidence of significant gastroparesis