Viewing Study NCT06191289



Ignite Creation Date: 2024-05-06 @ 7:57 PM
Last Modification Date: 2024-10-26 @ 3:17 PM
Study NCT ID: NCT06191289
Status: RECRUITING
Last Update Posted: 2024-04-24
First Post: 2023-12-20

Brief Title: Neurocognitive Mechanisms of Perimenstrual Estrogen Effects on Suicidality
Sponsor: University of Illinois at Chicago
Organization: University of Illinois at Chicago

Study Overview

Official Title: Clarifying the Endocrinology of Acute Risk 4 CLEAR-4 Neurocognitive Mechanisms of Perimenstrual Estrogen Effects on Suicidality
Status: RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CLEAR-4
Brief 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 perimenstrual administration of estradiol and 2 natural perimenstrual withdrawal from estradiol during placebo
Detailed Description: Previous work from our group demonstrates that perimenstrual worsening of suicidal thoughts in females is caused by normal perimenstrual withdrawal from the ovarian steroid estradiol E2 since perimenstrual administration of E2P4 or E2 alone prevented the perimenstrual worsening of suicidal ideation observed under placebo In the present study we follow up on that work with an additional mechanistic crossover trial in which E2 will be administered perimenstrually E2 condition or not PBO condition and neurocognitive mechanisms of suicidal symptom improvement will be probed

50 30 completers female outpatients with past-month suicidal ideation but minimal imminent risk for attempt will complete self-reports and clinical interviews measuring the presence and severity of suicidal ideation in each of two conditions A B order randomized across two menstrual cycles A perimenstrual E2 withdrawaldepletion under placebo B perimenstrual administration of E2 A washout cycle will separate conditions Analyses will compare the perimenstrual trajectories of symptoms and suicidality across the two conditions

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None