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Estradiol and Fear Extinction in Anorexia Nervosa (AN)

Primary Purpose

Anorexia Nervosa

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Estradiol
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring estrogen, anxiety, amenorrhea, eating disorders

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria (AN):

  • Previous diagnosis of recent AN with BMI of <18.5 (within past year)
  • Current BMI > 19.0 and < 23.0 kg/m2
  • Amenorrhea or oligomenorrhea

Inclusion Criteria (Healthy Controls):

  • BMI > 19 < 23 kg/m2
  • Taking hormone-based contraceptives for a period of one month or more
  • Eating disorders symptom scores within one standard deviation of healthy controls

Exclusion Criteria (AN):

  • Any medical or psychiatric problem requiring urgent medical or psychiatric attention, including acute suicidality
  • History of breast cancer, deep vein thrombosis, pulmonary embolism, myocardial infarction or stroke, diabetes, liver disease, known thrombophilic disease
  • Currently taking estrogen or progesterone medication
  • Tobacco use greater than 1 pack per week
  • Use of St. John's Wort, Phenobarbital, phenytoin, carbamazepine, rifampin, and dexamethasone can all decrease plasma estrogen level because they are CYP3A4 inducers. Cimetidine, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice as these may increase plasma estrogen, potentially increasing the presence of side effects
  • Pregnant, lactating or unwilling to use appropriate birth control (which may include abstinence) to prevent pregnancy for the duration of study participation (i.e. up to 4 weeks)
  • Allergy to estradiol or medroxyprogesterone or ingredients in food items used for test meals
  • Undiagnosed, abnormal vaginal bleeding

Exclusion Criteria (Healthy Controls):

  • Ever diagnosed with an Eating Disorder
  • Any medical or psychiatric problem requiring urgent medical or psychiatric attention, including acute suicidality
  • Pregnant, lactating or unwilling to use appropriate birth control (which may include abstinence) to prevent pregnancy for the duration of study participation (i.e. up to 4 weeks)
  • Food allergies to items in the test meal

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Estrogen

Arm Description

AN participants receive a course of transdermal estradiol treatment.

Outcomes

Primary Outcome Measures

Electrodermal skin conductance activity (EDA) during a test meal
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

Heart rate variability during a test meal
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
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).
Salivary cortisol concentration during a test meal
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.

Full Information

First Posted
May 23, 2016
Last Updated
August 22, 2018
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02792153
Brief Title
Estradiol and Fear Extinction in Anorexia Nervosa (AN)
Official Title
Estradiol and Fear Extinction for Calorie-Dense Foods in Weight Restored Adult Women With Anorexia Nervosa (AN)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The study was withdrawn after 18 months due to lack of recruitment.
Study Start Date
December 2016 (undefined)
Primary Completion Date
August 22, 2018 (Actual)
Study Completion Date
August 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
estrogen, anxiety, amenorrhea, eating disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Estrogen
Arm Type
Experimental
Arm Description
AN participants receive a course of transdermal estradiol treatment.
Intervention Type
Drug
Intervention Name(s)
Estradiol
Other Intervention Name(s)
Climara
Intervention Description
AN participants will be prescribed 28 days of transdermal estradiol 0.1 mg/d (Days 1-28) plus 10 days (days 21-31) oral medroxyprogesterone 2.5 mg/d.
Primary Outcome Measure Information:
Title
Electrodermal skin conductance activity (EDA) during a test meal
Description
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).
Time Frame
Baseline (day 1) and post-treatment (day 21)
Secondary Outcome Measure Information:
Title
Heart rate variability during a test meal
Description
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).
Time Frame
Baseline (day 1) and post-treatment (day 21)
Title
Subjective ratings of anxiety
Description
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).
Time Frame
Baseline (day 1) and post-treatment (day 21)
Title
Salivary cortisol concentration during a test meal
Description
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.
Time Frame
Baseline (day 1) and post-treatment (day 21)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (AN): Previous diagnosis of recent AN with BMI of <18.5 (within past year) Current BMI > 19.0 and < 23.0 kg/m2 Amenorrhea or oligomenorrhea Inclusion Criteria (Healthy Controls): BMI > 19 < 23 kg/m2 Taking hormone-based contraceptives for a period of one month or more Eating disorders symptom scores within one standard deviation of healthy controls Exclusion Criteria (AN): Any medical or psychiatric problem requiring urgent medical or psychiatric attention, including acute suicidality History of breast cancer, deep vein thrombosis, pulmonary embolism, myocardial infarction or stroke, diabetes, liver disease, known thrombophilic disease Currently taking estrogen or progesterone medication Tobacco use greater than 1 pack per week Use of St. John's Wort, Phenobarbital, phenytoin, carbamazepine, rifampin, and dexamethasone can all decrease plasma estrogen level because they are CYP3A4 inducers. Cimetidine, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice as these may increase plasma estrogen, potentially increasing the presence of side effects Pregnant, lactating or unwilling to use appropriate birth control (which may include abstinence) to prevent pregnancy for the duration of study participation (i.e. up to 4 weeks) Allergy to estradiol or medroxyprogesterone or ingredients in food items used for test meals Undiagnosed, abnormal vaginal bleeding Exclusion Criteria (Healthy Controls): Ever diagnosed with an Eating Disorder Any medical or psychiatric problem requiring urgent medical or psychiatric attention, including acute suicidality Pregnant, lactating or unwilling to use appropriate birth control (which may include abstinence) to prevent pregnancy for the duration of study participation (i.e. up to 4 weeks) Food allergies to items in the test meal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Guarda, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Estradiol and Fear Extinction in Anorexia Nervosa (AN)

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