Estradiol and Fear Extinction in Anorexia Nervosa (AN)
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|ClinicalTrials.gov Identifier: NCT02792153|
Recruitment Status : Withdrawn (The study was withdrawn after 18 months due to lack of recruitment.)
First Posted : June 7, 2016
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa||Drug: Estradiol||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Estradiol and Fear Extinction for Calorie-Dense Foods in Weight Restored Adult Women With Anorexia Nervosa (AN)|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||August 22, 2018|
|Actual Study Completion Date :||August 22, 2018|
AN participants receive a course of transdermal estradiol treatment.
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 Name: Climara
- Electrodermal skin conductance activity (EDA) during a test meal [ Time Frame: 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).
- Heart rate variability during a test meal [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792153
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Angela Guarda, MD||Johns Hopkins University|