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Hormone swings linked to suicide risk in women: new study

NCT ID NCT04112368

Knowledge-focused Sponsor: University of Illinois at Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether stabilizing hormones with estrogen patches and progesterone pills could reduce suicidal thoughts in women with recent suicidal ideation. 124 women participated, tracking their daily mood and suicide risk over a month. The goal was to understand how natural hormone cycles influence short-term suicide risk, not to provide a treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Estradiol transdermal patch and oral micronized progesterone
What this could lead to
If successful, this could point toward a treatment that prevents monthly worsening of suicide risk in women of reproductive age.
What could go wrong
This is a small, early-phase study focused on understanding biology, not testing a treatment. The results may not lead to a direct therapy, and the hormone interventions may have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

124 people

The number who actually took part.

Started

Sep 2020

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Suicidal Ideation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Suicidal ideation

Contacts and locations

Locations

  • University of Illinois Neuropsychiatric Institute

    Chicago, Illinois, 60612, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.