TERMINATED

Neurocognitive Mechanisms of Perimenstrual Estrogen Effects on Suicidality

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Conditions

SuicideMENSTRUAL CYCLEHORMONESESTROGENREWARDEXECUTIVE FUNCTION

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-16
Study Completion:2024-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06191289

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.

Ages Eligible for Study:20 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to adhere to medication regimen
  2. * Speaks English
  3. * Assigned female at birth with intact ovaries
  4. * Premenopausal
  5. * Normal menstrual cycles between 24-32 days
  6. * Under current care of an outpatient mental health provider with visits occurring at least once every 3 months.
  7. * At least 1 year postpartum.
  8. * Willing to use a barrier method of birth control during the study.
  9. * Normal weight (BMI between 18-29)
  10. * Must report at least some recent suicidal ideation (in the past month) at the time of recruitment.
  11. * 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.
  1. * Must not be pregnant, breastfeeding, or trying to become pregnant.
  2. * 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.
  3. * 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.
  4. * Any current cigarette smoking is exclusionary.
  5. * 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).
  6. * Must not report any history of manic episode, any history of psychotic symptoms, or current substance use disorder.

Contacts and Locations

Principal Investigator

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 Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-16
Study Completion Date2024-12-01

Study Record Updates

Study Start Date2024-03-16
Study Completion Date2024-12-01

Terms related to this study

Keywords Provided by Researchers

  • MENSTRUAL CYCLE
  • HORMONES
  • ESTROGEN
  • REWARD
  • EXECUTIVE FUNCTION

Additional Relevant MeSH Terms

  • Suicide