Phase 4
N=124
Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach
Suicidal Ideation
Bottom Line
View on ClinicalTrials.gov: NCT04112368 ↗Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Perimenstrual Change in Daily Adult Suicidal Ideation Questionnaire (ASIQ) Scores — .178; -.051 Mean Score Change — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Estradiol Transdermal Patch 0.1 mg/24 hrs (Drug); Oral Micronized Progesterone 200mg (Drug); Inactive Clear Patch (Drug); Placebo capsule (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perimenstrual Change in Daily Adult Suicidal Ideation Questionnaire (ASIQ) Scores |
.178; -.051 | <.001 sig |
| PRIMARY Perimenstrual Change in Daily Columbia Suicide Severity Rating Scale (C-SSRS) Screening Interview Planning Item Scores |
-.04; .021 | .026 sig |
| SECONDARY Perimenstrual Change in Daily Beck Hopelessness Scale (BHS) Short Form Scores |
-.004; .25 | .052 |
| SECONDARY Perimenstrual Change in Daily Brief Agitation Measure (BAM) Scores |
-.066; .005 | — |
Summary
Female suicide attempts occur more often in the weeks before and after menses onset, and have been linked to ovarian hormone withdrawal. The proposed project will use a two-week intervention to stabilize hormones in females with recent suicidal thoughts; this paradigm is a safe way to learn how cyclical changes in hormones and their metabolites influence short-term risk of suicide. The data acquired will contribute to our understanding of the biology of acute suicide risk and advance efforts to develop safe and effective treatments that eliminate predictable monthly worsening of suicide risk in reproductive-age females.
Eligibility 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 18-29)
- 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.
Data sourced from ClinicalTrials.gov (NCT04112368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.