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The study was withdrawn after 18 months due to lack of recruitment.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estrogen | Experimental | AN participants receive a course of transdermal estradiol treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (day 1) and post-treatment (day 21) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (day 1) and post-treatment (day 21) |
| Subjective ratings of anxiety |
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Inclusion Criteria (AN):
Inclusion Criteria (Healthy Controls):
Exclusion Criteria (AN):
Exclusion Criteria (Healthy Controls):
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| Name | Affiliation | Role |
|---|---|---|
| Angela Guarda, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D001008 | Anxiety Disorders |
| D000568 | Amenorrhea |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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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). |
| Baseline (day 1) and post-treatment (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. | Baseline (day 1) and post-treatment (day 21) |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |