Overview

Ovarian Hormones and Suicide Risk

Status:
Active, not recruiting
Trial end date:
2021-06-01
Target enrollment:
0
Participant gender:
Female
Summary
This within-person, crossover, 3-condition, placebo-controlled study compares the impact of three perimenstrual conditions on severity of suicidal symptoms in females with past-month suicidality but minimal risk of imminent suicide attempt. The three conditions are (1) perimenstrual withdrawal from estradiol only (during progesterone stabilization), (2) perimenstrual withdrawal from progesterone only (during estradiol stabilization), and (3) perimenstrual withdrawal from both estradiol and progesterone during placebo.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Illinois at Chicago
Collaborator:
National Institute of Mental Health (NIMH)
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Hormones
Polyestradiol phosphate
Progesterone
Criteria
Inclusion Criteria:

- Ability to adhere to medication regimen

- Speaks English

- Assigned female at birth with intact ovaries

- Premenopausal

- Normal menstrual cycles between 25-35 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 18.00-29.99)

- 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 that may interfere
with the aims of the study or make the experimental protocol unsafe, 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 current diagnosis of major depressive episode with peripartum onset
(current episode), and must not be currently receiving treatment for 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.

- Must not test positive for (unprescribed) opioid use, methamphetamine use, or cocaine
use at the start of an experimental condition.