Anorexia Nervosa
Conditions
Keywords
estrogen, anxiety, amenorrhea, eating disorders
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).
Interventions
DRUGEstradiol
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.
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed