Status:
TERMINATED
Neurocognitive Mechanisms of Perimenstrual Estrogen Effects on Suicidality
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Suicide
Eligibility:
FEMALE
20-40 years
Phase:
PHASE2
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 min...
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 perim...
Eligibility Criteria
Inclusion
- Ability to adhere to medication regimen
- Speaks English
- Assigned female at birth with intact ovaries
- Premenopausal
- Normal menstrual cycles between 24-32 days
- Under current care of an outpatient mental health provider with visits occurring at least once every 3 months.
- At least 1 year postpartum.
- Willing to use a barrier method of birth control during the study.
- Normal weight (BMI between 18-29)
- Must report at least some recent suicidal ideation (in the past month) at the time of recruitment.
- Must be categorized as having acceptably low imminent risk for suicidal crisis/attempt by a licensed clinical psychologist utilizing evidence-based clinical and research guidelines for imminent suicide risk management.
Exclusion
- Must not be pregnant, breastfeeding, or trying to become pregnant.
- Must not be taking any form of exogenous hormones or hormonal intrauterine device, and must have ended previous use of hormonal preparations at least one month prior to the study.
- Must not have a personal history of any chronic medical condition, including but not limited to metabolic or autoimmune disease, epilepsy, endometriosis, cancer, diabetes, cardiovascular, gastrointestinal, hepatic, renal, or pulmonary disease, and no personal or first degree family history of thromboembolic events.
- Any current cigarette smoking is exclusionary.
- Must not report a history of clinical diagnosis or treatment for postpartum depression or premenstrual dysphoric disorder (Note: Premenstrual Dysphoric - - - Disorder diagnosis must have been made based on prospective daily ratings).
- Must not report any history of manic episode, any history of psychotic symptoms, or current substance use disorder.
Key Trial Info
Start Date :
March 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06191289
Start Date
March 16 2024
End Date
December 1 2024
Last Update
October 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Illinois Neuropsychiatric Institute
Chicago, Illinois, United States, 60612