Effect of Perimenstrual Ovarian Steroid Supplementation on Perimenstrual Suicidality
Summary
This within-person, crossover, 2-condition, placebo-controlled study compares the impact of two perimenstrual conditions on severity of suicidal symptoms in females with past-month suicidality but minimal risk of imminent suicide attempt. The two conditions are (1) natural perimenstrual withdrawal from estradiol and progesterone (during placebo), (2) perimenstrual stabilization of estradiol and progesterone using transdermal estradiol and oral micronized progesterone.
Timeline
- Start
- 2016-12-31
- Primary completion
- 2017-11
- Completion
- 2017-11
Outcome
Met primary endpoint
registry analysis (superiority test); Active Estradiol + Progesterone vs Placebos; p = .012; Mean Difference (Final Values) .26; t-test, 2 sided NCT03720847 ↗
registry analysis (superiority test); Active Estradiol and Progesterone vs Placebos; p = .030; Mean Difference (Final Values) .21; t-test, 2 sided NCT03720847 ↗
Publications
- Barone JC, Wenzel E, Alluri V, Moriarity D, Pinna G, Walsh E, Rubinow DR, Morrow AL, Eisenlohr-Moul TA. Effects of estrogen and progesterone on neuroactive steroids and cytokines in patients with suicidality. Psychoneuroendocrinology. 2023 Nov;157:106359. doi: 10.1016/j.psyneuen.2023.106359. Epub 2023 Aug 9.
- Owens SA, Schmalenberger KM, Bowers S, Rubinow DR, Prinstein MJ, Girdler SS, Eisenlohr-Moul TA. Cyclical exacerbation of suicidal ideation in female outpatients: Prospective evidence from daily ratings in a transdiagnostic sample. J Psychopathol Clin Sci. 2023 Aug;132(6):704-715. doi: 10.1037/abn0000838. Epub 2023 Jun 15.
- Eisenlohr-Moul TA, Bowers SM, Prinstein MJ, Schmalenberger KM, Walsh EC, Young SL, Rubinow DR, Girdler SS. Effects of acute estradiol and progesterone on perimenstrual exacerbation of suicidal ideation and related symptoms: a crossover randomized controlled trial. Transl Psychiatry. 2022 Dec 30;12(1):528. doi: 10.1038/s41398-022-02294-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 0.1 mg | Other |
| Subject | Progesterone | Other / unclassified | 100 mg | Oral |
Indications
No indication recorded.