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Recruiting NCT05111977

Gastrointestinal Interoception in Anorexia Nervosa

Trial Parameters

Condition Anorexia Nervosa
Sponsor Laureate Institute for Brain Research, Inc.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 150
Sex FEMALE
Min Age 15 Years
Max Age 40 Years
Start Date 2021-12-01
Completion 2026-04-30
Interventions
Vibrant capsule

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.

Eligibility Criteria

Inclusion Criteria: HC Inclusion criteria: i. Body mass index ≥ 18.5. 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 ≥ 18.5. 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:

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