A Neurocomputational Assay of Gastrointestinal Interoception in Anorexia Nervosa

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 15
Maximum Age: 40
Healthy Volunteers: t
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• 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: 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

Locations
United States
Oklahoma
Laureate Institute for Brain Research
RECRUITING
Tulsa
Contact Information
Primary
Jaimee Bruce, BSN
JBruce@laureateinstitute.org
9185025145
Backup
Sahib Khalsa, MD
skhalsa@laureateinstitute.org
9185025743
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 150
Treatments
Experimental: Capsule stimulation
Participants in this arm will receive gastric stimulation via the Vibrant capsule
Placebo_comparator: Placebo stimulation
Participants in this arm will receive no gastric stimulation via a placebo capsule
Related Therapeutic Areas
Sponsors
Leads: Laureate Institute for Brain Research, Inc.

This content was sourced from clinicaltrials.gov