Estradiol and Fear Extinction in Anorexia Nervosa (AN)

Sponsor

Johns Hopkins University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02792153

Collaborator

(none)

Enrollment

Location

Arm

20.7

Duration (Months)

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa	Drug: Estradiol	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Estradiol and Fear Extinction for Calorie-Dense Foods in Weight Restored Adult Women With Anorexia Nervosa (AN)

Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Aug 22, 2018

Actual Study Completion Date :

Aug 22, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Estrogen AN participants receive a course of transdermal estradiol treatment.	Drug: Estradiol 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. Other Names: Climara

Arm

Intervention/Treatment

Experimental: Estrogen

AN participants receive a course of transdermal estradiol treatment.

Drug: Estradiol

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.

Other Names:

Climara

Outcome Measures

Primary Outcome Measures

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

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).
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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