Neurocognitive Mechanisms of Perimenstrual Estrogen Effects on Suicidality

Description

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.

Conditions

Suicide

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Study Overview

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Study Details

Study overview

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.

Clarifying the Endocrinology of Acute Risk 4 (CLEAR-4): Neurocognitive Mechanisms of Perimenstrual Estrogen Effects on Suicidality

Neurocognitive Mechanisms of Perimenstrual Estrogen Effects on Suicidality

Condition
Suicide
Intervention / Treatment

-

Contacts and Locations

Chicago

University of Illinois Neuropsychiatric Institute, Chicago, Illinois, United States, 60612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

20 Years to 40 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Illinois at Chicago,

Tory A Eisenlohr-Moul, Ph.D., PRINCIPAL_INVESTIGATOR, University of Illinois at Chicago

Elizabeth Mulligan, Ph.D., PRINCIPAL_INVESTIGATOR, University of Illinois at Chicago

Katja M Schmalenberger, Ph.D., PRINCIPAL_INVESTIGATOR, University of Illinois at Chicago

Study Record Dates

2024-12-31