At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach
In Brief
A Phase 4 clinical trial evaluating Estradiol Transdermal Patch 0.1 mg/24 hrs, Oral Micronized Progesterone 200mg, and 2 other interventions for Suicidal Ideation. Completed, enrolled 124 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Estradiol transdermal patch delivering 0.1 mg/24 hour administered by affixing to skin for 14 days starting on day 7 after ovulation
100 mg oral micronized progesterone taken orally twice daily for 14 days starting day 7 after ovulation (200mg total per day)
Matching placebo patch administered by affixing to skin for 14 days starting on day 7 after ovulation
Matching placebo capsules administered twice daily for 14 days starting day 7 after ovulation