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The Role of Estrogen in the Neurobiology of Eating Disorders

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ClinicalTrials.gov Identifier: NCT03740204
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Madhusmita Misra, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE November 5, 2018
First Posted Date  ICMJE November 14, 2018
Last Update Posted Date June 17, 2019
Actual Study Start Date  ICMJE June 13, 2019
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • Change in inhibition-switching performance on the Delis-Kaplan Executive Function System Color-Word Interference Test (D-KEFS CWIT) with 17-β estradiol versus placebo [ Time Frame: Baseline to 8 weeks ]
  • Change in Temporal Experience of Pleasure Scale (TEPS) Consummatory Pleasure score (Range: 8-48; direction: Higher values indicate more pronounced consummatory pleasure/better outcome) with 17-β estradiol versus placebo [ Time Frame: Baseline to 8 weeks ]
  • Change in delay discounting parameter k using the Monetary Choice Questionnaire with 17-β estradiol versus placebo [ Time Frame: Baseline to 8 weeks ]
  • Change in Eating Disorder Inventory-2 (EDI-2) Body Dissatisfaction score (Range: 0-36; direction: Higher values indicate more pronounced body dissatisfaction/worse outcome) with 17-β estradiol versus placebo [ Time Frame: Baseline to 12 weeks ]
  • Change in EDI-2 Drive for Thinness score (Range: 0-28; direction: Higher values indicate more pronounced drive for thinness/worse outcome) with 17-β estradiol versus placebo [ Time Frame: Baseline to 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03740204 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • Change in functional magnetic resonance imaging (fMRI) activation of the dorsolateral prefrontal cortex (DLPFC) and anterior cingulate cortex (ACC) during a task switching paradigm with 17-β estradiol versus placebo [ Time Frame: Baseline to 8 weeks ]
  • Change in fMRI activation of the ventromedial prefrontal cortex (VMPFC) and ventral striatum in response to reward receipt with 17-β estradiol versus placebo [ Time Frame: Baseline to 8 weeks ]
  • Change in fMRI activation of the VMPFC and ventral striatum during delay discounting with 17-β estradiol versus placebo [ Time Frame: Baseline to 8 weeks ]
  • Change in the Eating Disorder Examination (EDE) Dietary Restraint subscale (Range: 0-6; direction: Higher values indicate more pronounced dietary restraint/worse outcome) with 17-β estradiol versus placebo [ Time Frame: Baseline to 12 weeks ]
  • Change in caloric intake by 4-day food diary with 17-β estradiol versus placebo [ Time Frame: Baseline to 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Estrogen in the Neurobiology of Eating Disorders
Official Title  ICMJE The Role of Estrogen in the Neurobiology of Eating Disorders: A Study of Cognitive Flexibility and Reward in Eating Disorders
Brief 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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Eating Disorders
  • Hypoestrogenemia
Intervention  ICMJE
  • Drug: 17-β estradiol transdermal patches with cyclic progesterone
    17-β estradiol transdermal patches (100 mcg 17-β estradiol/day) with cyclic progesterone (200 mg micronized progesterone daily for 12 days every month)
  • Drug: Placebo patch and pill
    Placebo patch and pill
Study Arms  ICMJE
  • Experimental: 17-β estradiol with cyclic progesterone
    Intervention: Drug: 17-β estradiol transdermal patches with cyclic progesterone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo patch and pill
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 9, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 26 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Madhusmita Misra, M.D., M.P.H. 617-726-5790 mmisra@mgh.harvard.edu
Contact: Franziska Plessow, Ph.D. 617-726-0784 fplessow@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03740204
Other Study ID Numbers  ICMJE 1R01MH116205( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Madhusmita Misra, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Madhusmita Misra, M.D., M.P.H. Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP