Study protocol for a randomized, placebo-controlled, double-masked mechanistic clinical trial of transdermal estrogen replacement in hypoestrogenic eating disorders to explore the role of estrogen on cognitive flexibility and reward processing
We hypothesize that estrogen replacement will (1) increase cognitive flexibility, reward responsiveness, and delay discounting, and (2) reduce ED pathology; and (3) 8-week changes in cognitive flexibility, reward responsiveness, and delay discounting will mediate 12-week changes in ED pathology. These data will systematically probe the role of estrogen in key neurocognitive features associated with poor ED outcomes to guide development of novel interventions for this population.
Authors
- Adrienne L. Romer (ORCID: https://orcid.org/0000-0002-1626-0857)
- Poornima Kumar (ORCID: https://orcid.org/0000-0002-9548-3281)
- Kristin N. Javaras (ORCID: https://orcid.org/0000-0003-0885-2331)
- Meghan Lauze (ORCID: https://orcid.org/0009-0001-5282-8032)
- Jennifer J. Thomas (ORCID: https://orcid.org/0000-0003-2601-581X)
- Felicia Petterway (ORCID: https://orcid.org/0000-0001-9742-0957)
- Madhusmita Misra (ORCID: https://orcid.org/0000-0002-9405-2981)
- Esther Dechant
- Diego A. Pizzagalli (ORCID: https://orcid.org/0000-0002-7772-1143)
- Lauren Breithaupt (ORCID: https://orcid.org/0000-0002-2439-6519)
- Franziska Plessow (ORCID: https://orcid.org/0000-0002-9721-7817)
- Kamryn T. Eddy (ORCID: https://orcid.org/0000-0002-1586-0930)
- Elizabeth A. Lawson (ORCID: https://orcid.org/0000-0001-8619-3349)
- John Halperin (ORCID: https://orcid.org/0000-0003-1170-1710)
- Lauren Lindman
- Hang Lee
- Meghan Slattery
- Martin Powers
- David J Alperovitz
- Mia Cravitz
- Sarah Naticchia
- Siddarth Seenivasa
Institutions
- Brigham and Women's Hospital (US)
- Harvard University (US)
- University of California, San Francisco (US)
- McLean Hospital (US)
- Massachusetts General Hospital (US)
- University of Virginia (US)
- Virginia Tech (US)
Publication Details
- Journal
- Contemporary Clinical Trials
- Published
- 2025-04-26
- DOI
- https://doi.org/10.1016/j.cct.2025.107924
- Citations
- 1
- Primary Topic
- Eating Disorders and Behaviors
- Type
- article
- Field-Weighted Citation Impact
- 2.31