The Role of Estrogen in the Neurobiology of Eating Disorders
The Role of Estrogen in the Neurobiology of Eating Disorders: A Study of Cognitive Flexibility and Reward in Eating Disorders
Massachusetts General Hospital
120 participants
Jun 13, 2019
INTERVENTIONAL
Conditions
Summary
This is a randomized, double blind, placebo-controlled study of the effects of transdermal estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder pathology in hypoestrogenemic female adolescents and young adults (ages 14-35 years) with an eating disorder characterized by extreme dietary restriction and/or excessive exercise. Subjects will be randomized 1:1 to 12 weeks of transdermal estradiol with cyclic progesterone or placebo patches and cyclic placebo pills. Study visits include a screening visit to determine eligibility and visits at baseline, 8 weeks, and 12 weeks. Study procedures comprise behavioral, neuroimaging, and endocrine assessments.
Eligibility
Inclusion Criteria6
- Female
- -35 years
- Bone age ≥13.5 years (applicable only for participants <16 years)
- Clinically significant eating disorder characterized by restriction and/or excessive exercise and high drive for thinness
- Hypoestrogenemia: Oligo-amenorrhea defined as lack of menses for ≥3 months within a 6-month period of oligomenorrhea (cycle length ≥5 weeks) or absence of menses at >15 years if premenarchal or low estradiol levels evaluated by the study physician
- Low or normal weight defined by a body mass index that is <85th percentile for 14-18 year olds and a body mass index <25 kg/m2 for adults
Exclusion Criteria10
- Suicidal ideation where outpatient treatment is determined unsafe by study clinician
- Other causes of oligo-amenorrhea, unless a study clinician determines that missed menstrual periods are more likely a consequence of restrictive eating
- Medications that contain estrogen ± progesterone within the past 3 months
- Levonorgestrel-releasing intrauterine device if subject is unable to provide two to three weekly blood samples for estradiol of if estradiol levels are determined to be too high by study doctor
- Neurological or psychiatric disorders that may impact neural circuitry of interest
- Lifetime history of seizure disorder or electroconvulsive therapy
- Pregnancy/breastfeeding
- Gastrointestinal tract surgery
- Contraindications to estrogen use
- Any other significant illness or condition that the investigator determines could interfere with study participation or safety or put the subject at any unnecessary risk
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Interventions
17-β estradiol transdermal patches (100 mcg 17-β estradiol/day) with cyclic progesterone (200 mg micronized progesterone daily for 12 days every month)
Placebo patch and pill
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03740204