drugset
drugset / Trial / NCT04112368

Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach

NCT04112368 ↗

Phase 4 Completed 124 enrolled University of Illinois at Chicago
RandomizedCrossoverTriple-blindBasic science

Summary

Female suicide attempts occur more often in the weeks before and after menses onset, and have been linked to ovarian hormone withdrawal. The proposed project will use a two-week intervention to stabilize hormones in females with recent suicidal thoughts; this paradigm is a safe way to learn how cyclical changes in hormones and their metabolites influence short-term risk of suicide. The data acquired will contribute to our understanding of the biology of acute suicide risk and advance efforts to develop safe and effective treatments that eliminate predictable monthly worsening of suicide risk in reproductive-age females.

Timeline

Start
2020-09-15
Primary completion
2024-08-01
Completion
2024-08-01

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo Patch + Pills vs Transdermal Estradiol + Oral Micronized Progesterone; p <.001 NCT04112368 ↗

registry analysis (superiority test); Transdermal Estradiol + Oral Micronized Progesterone vs Placebo Patch + Placebo Pills; p = .026 NCT04112368 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Other / unclassified 0.1 mg Other
Subject Progesterone Other / unclassified 200 mg Oral

Indications

No indication recorded.