Neurocognitive Mechanisms of Perimenstrual Estrogen Effects on Suicidality

Launched by UNIVERSITY OF ILLINOIS AT CHICAGO · Dec 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how changes in estrogen levels during the menstrual cycle might affect suicidal thoughts in women. The researchers want to understand the differences between two situations: one where participants receive estrogen (a hormone) and another where they do not receive it (placebo). This study is specifically for women who have experienced suicidal thoughts in the last month but are not at immediate risk of attempting suicide.

To be eligible for this trial, participants need to be premenopausal women assigned female at birth, between the ages of 18 and 40, who have regular menstrual cycles and are currently receiving mental health care. They must also be at least one year postpartum, willing to use a barrier method of birth control, and have a normal weight. During the study, participants will be closely monitored and can expect to take medication in two different conditions. It's important to know that women who are pregnant, breastfeeding, or have certain medical histories, including current smoking, will not be eligible for this trial.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.