Estradiol and Fear Extinction in Anorexia Nervosa (AN)

NCT02792153 | Withdrawn Phase 1

• 1 other identifier: IRB00030009
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Anorexia Nervosa

Keywords

estrogen; anxiety; amenorrhea; eating disorders

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Heart rate variability during a test meal

  Baseline (day 1) and post-treatment (day 21)

• Subjective ratings of anxiety

  Baseline (day 1) and post-treatment (day 21)

• Salivary cortisol concentration during a test meal

  Baseline (day 1) and post-treatment (day 21)

Study Arms (1)

Estrogen

EXPERIMENTAL

AN participants receive a course of transdermal estradiol treatment.

Drug: Estradiol

Interventions

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.

Also known as: Climara

Estrogen

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa; Anxiety Disorders; Amenorrhea; Feeding and Eating Disorders

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Mental Disorders; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Angela Guarda, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 7, 2016
• Study Start: December 1, 2016
• Primary Completion: August 22, 2018
• Study Completion: August 22, 2018
• Last Updated: August 24, 2018

Record last verified: 2018-08

Locations

US (1)