drugset / Trial / NCT04051320
Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model
Phase 2
Completed
23 enrolled
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH) · collab
Non-randomizedParallel-groupDouble-blindBasic science
Summary
The proposed study involves experimentally manipulating reproductive hormones in nonpregnant, euthymic women to create a scaled down version of the changes that occur during pregnancy and the postpartum period. This endocrine manipulation paradigm, which the investigators have shown provokes irritability in past studies, will be used to examine the neurocircuitry underlying irritability under baseline and hormone challenge conditions among women who are hormone sensitive (HS+; n=15) and non-hormone sensitive (HS-; n=15). The long-term goal of this research is to advance understanding of the neural systems underlying both the triggering of and susceptibility to irritability in women. The objective of the current project is to examine whether HS+ show differences in the behavioral activation system relative to HS- under baseline and hormone challenge conditions using functional magnetic resonance imaging (fMRI) and behavioral tests.
Timeline
- Start
- 2020-01-02
- Primary completion
- 2022-07-15
- Completion
- 2022-07-19
Publications
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- Background Wingo PA, Layde PM, Lee NC, Rubin G, Ory HW. The risk of breast cancer in postmenopausal women who have used estrogen replacement therapy. JAMA. 1987 Jan 9;257(2):209-15.
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- Background Breast cancer and hormone replacement therapy: collaborative reanalysis of data from 51 epidemiological studies of 52,705 women with breast cancer and 108,411 women without breast cancer. Collaborative Group on Hormonal Factors in Breast Cancer. Lancet. 1997 Oct 11;350(9084):1047-59.
- Background Chen WY, Manson JE, Hankinson SE, Rosner B, Holmes MD, Willett WC, Colditz GA. Unopposed estrogen therapy and the risk of invasive breast cancer. Arch Intern Med. 2006 May 8;166(9):1027-32. doi: 10.1001/archinte.166.9.1027.
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- Background Chlebowski RT, Hendrix SL, Langer RD, Stefanick ML, Gass M, Lane D, Rodabough RJ, Gilligan MA, Cyr MG, Thomson CA, Khandekar J, Petrovitch H, McTiernan A; WHI Investigators. Influence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women: the Women's Health Initiative Randomized Trial. JAMA. 2003 Jun 25;289(24):3243-53. doi: 10.1001/jama.289.24.3243.
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- Background Hommer RE, Meyer A, Stoddard J, Connolly ME, Mogg K, Bradley BP, Pine DS, Leibenluft E, Brotman MA. Attention bias to threat faces in severe mood dysregulation. Depress Anxiety. 2014 Jul;31(7):559-65. doi: 10.1002/da.22145. Epub 2013 Jun 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 2 mg | — |
| Subject | Leuprolide | Other / unclassified | 3.75 mg | Intramuscular |
| Subject | Progesterone | Other / unclassified | 200 mg | — |