The Role of Estrogen in the Neurobiology of Eating Disorders
| Status: | Recruiting |
|---|---|
| Conditions: | Eating Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 16 - 26 |
| Updated: | 2/23/2019 |
| Start Date: | February 19, 2019 |
| End Date: | September 30, 2023 |
| Contact: | Madhusmita Misra, M.D., M.P.H. |
| Email: | mmisra@mgh.harvard.edu |
| Phone: | 617-726-5790 |
The Role of Estrogen in the Neurobiology of Eating Disorders: A Study of Cognitive Flexibility and Reward in Eating Disorders
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 16-26) 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.
estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder
pathology in hypoestrogenemic female adolescents and young adults (ages 16-26) 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.
Inclusion criteria:
- Female
- 16-26 years
- Right-handed
- Clinically significant eating disorder characterized by restriction and/or excessive
exercise and high drive for thinness
- Hypoestrogenemia: Oligoamenorrhea 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
- Low or normal weight defined by a weight that is <85th percentile for 16-18 year olds
and a body mass index <25 kg/m2 for adults
Exclusion criteria:
- Suicidal ideation where outpatient treatment is determined unsafe by study clinician
- DSM-5 eating disorders characterized by bingeing or purging
- Other causes of oligo-amenorrhea
- Medications that contain estrogen ± progesterone within the past 3 months
- Neurological or psychiatric disorders that may impact neural circuitry of interest
- Lifetime history of seizure disorder or electro-convulsive therapy
- Pregnancy/breastfeeding
- Contraindications to MRI
- Gastrointestinal tract surgery
- Contraindications to estrogen use
- Psychotropic medications causing hyperprolactinemia
- 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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-5790
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