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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02148042
Other study ID # 1312M46141
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2014
Est. completion date July 2016

Study information

Verified date July 2019
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Anorexia nervosa is a chronic mental health condition characterized by maladaptive food consumption (i.e., hypophagia) and distorted body image. There is substantial evidence of a phenotypic overlap between anorexia nervosa and anxiety disorders, as well as data suggesting the two share a common genetic pathway. Despite these findings, little research has examined fear conditioning among individuals with anorexia nervosa, and no research has examined whether individuals with anorexia nervosa have a propensity to overgeneralize conditioned fear stimuli, one of the more robust fear-conditioning markers of anxiety disorders. The current study assesses generalization of conditioned fear with fear-potentiated startle: the cross-species enhancement of the startle reflex when an organism is in a state of fear. Animal data, as well as an emerging literature in humans, tightly links fear-potentiated startle to the amygdala-based fear circuit. Thus, evidence of overgeneralized fear-potentiated startle in anorexia nervosa would link this eating disorder to hypersensitivity of the fear circuit and could inform the development of novel pharmacologic and psychological treatments for anorexia nervosa based on treatment models used in the anxiety disorders literature.


Description:

The overarching objective of the current proposal is to examine the feasibility of applying a generalization of conditioned fear-potentiated startle paradigm, which has been used successfully to measure the sensitivity of fear networks in anxiety disorders, to adults with anorexia nervosa. The specific aim will be to examine whether conditioned-fear generalization gradients in anorexia nervosa participants differ from those in healthy controls. It is hypothesized that anorexia nervosa participants will display stronger generalization as indicated by less quadratic generalization gradients (i.e., a more gradual decline in conditioned fear as the generalization stimuli deviate from the conditioned fearful stimuli), which is indicative of a heightened sensitivity, or lower thresholds of activation, in the fear circuit (i.e., less danger information necessary to trigger the fear).


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults (age=18)

a. Anorexics

- Meet criteria for Diagnostic and Statistical Manual (DSM-5) anorexia nervosa

b. Controls

- age matched

- sex-matched

Exclusion Criteria:

- Criteria are met for a current or past Axis I disorder.

- Inability to read English

- Pregnancy/lactation

- Acute suicidality

- Medical instability as determined by a medical history visit and serum electrolyte testing,

- Medical conditions that may place the participant at risk (e.g., cardiovascular condition)

- Current use of medication that alter central nervous system function

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome variable is startle response (eye blink). Within 2 weeks
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