Estradiol and Fear Extinction in Anorexia Nervosa (AN)

Phase 1

Withdrawn

• Conditions: Anorexia Nervosa
• Interventions: Drug: Estradiol

• Registration Number: NCT02792153
• Lead Sponsor: Johns Hopkins University

Brief Summary

The purpose of this study is to determine whether estrogen may help reduce fear of high calorie-density foods in weight-restored women with Anorexia Nervosa (AN).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-07
• Study Start: 2016-12
• Status Verified: 2018-08
• Primary Completion: 2018-08-22
• Study Completion: 2018-08-22
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Estrogen	Estradiol	AN participants receive a course of transdermal estradiol treatment.

Primary Outcome Measures

Name	Time	Method
Electrodermal skin conductance activity (EDA) during a test meal	Baseline (day 1) and post-treatment (day 21)	Meal-related anxiety will be estimated from EDA recordings during a 90 minute test meal session pre- and post-treatment (day 1 and day 21). EDA will be reported as the rate of peaks (\>0.02 microsiemens) per second and the average skin conductance level (in microsiemens).

Secondary Outcome Measures

Name	Time	Method
Salivary cortisol concentration during a test meal	Baseline (day 1) and post-treatment (day 21)	The concentration of salivary cortisol will be assessed at multiple points (time 0 min, 5 min, 10 min, 20 min, 30 min, 50 min, 70 min and 90 min) during the test meal session. Test meals occur twice during the entire length of the study on day 1 and day 21. The cortisol response will be reported as area under the curve.
Heart rate variability during a test meal	Baseline (day 1) and post-treatment (day 21)	Variability in heart rate will be measured by the variation in interpeak (beat-to-beat) interval during the 90 minute test meal session pre- and post- treatment (day 1 and day 21).
Subjective ratings of anxiety	Baseline (day 1) and post-treatment (day 21)	Visual analog scales will be used to assess self-report anxiety at multiple points (time 0 min, 5 min, 10 min, 20 min, 30 min, 50 min, 70 min and 90 min) during the 90 minute test meal session pre- and post-treatment (day 1 and day 21).

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States