RECRUITING

The Role of Estrogen in the Neurobiology of Eating Disorders

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Role of Estrogen in the Neurobiology of Eating Disorders: A Study of Cognitive Flexibility and Reward in Eating Disorders

Quick Facts

Study Start:2019-06-13
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03740204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 35 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * 14-35 years
  3. * Bone age ≥13.5 years (applicable only for participants \<16 years)
  4. * Clinically significant eating disorder characterized by restriction and/or excessive exercise and high drive for thinness
  5. * 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
  6. * 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
  1. * Suicidal ideation where outpatient treatment is determined unsafe by study clinician
  2. * Other causes of oligo-amenorrhea, unless a study clinician determines that missed menstrual periods are more likely a consequence of restrictive eating
  3. * Medications that contain estrogen ± progesterone within the past 3 months
  4. * 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
  5. * Neurological or psychiatric disorders that may impact neural circuitry of interest
  6. * Lifetime history of seizure disorder or electroconvulsive therapy
  7. * Pregnancy/breastfeeding
  8. * Gastrointestinal tract surgery
  9. * Contraindications to estrogen use
  10. * 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

Contacts and Locations

Study Contact

Madhusmita Misra, M.D., M.P.H.
CONTACT
617-726-5790
mmisra@mgh.harvard.edu
Franziska Plessow, Ph.D.
CONTACT
617-726-3870
fplessow@mgh.harvard.edu

Principal Investigator

Madhusmita Misra, M.D., M.P.H.
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Madhusmita Misra, M.D., M.P.H., PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-13
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-06-13
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Adolescent
  • Amenorrhea
  • Anorexia Nervosa
  • Cognitive Flexibility
  • Dietary Restriction
  • Eating Disorders
  • Estrogen
  • Excessive Exercise
  • Females
  • Hypoestrogenemia
  • Reward

Additional Relevant MeSH Terms

  • Eating Disorders
  • Hypoestrogenemia