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Teen brain study: can hormone pills calm suicide risk?

NCT ID NCT07544966

Knowledge-focused Sponsor: University of North Carolina, Chapel Hill 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This study looks at how natural hormone changes during the menstrual cycle may make some teenage girls more irritable or depressed, especially those at risk for suicide. Researchers will give 50 girls ages 12-16 either a birth control pill to keep hormones steady or a placebo for 8 weeks each, then compare mood and brain scans. The goal is to understand the brain connections involved, not to test a new treatment.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

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

12 to 16 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Assigned female sex at birth * Between the ages of 12 and 16 * Be eligible to receive a low-dose oral contraceptive (COC) * Post-menarche. Participants will be post-menarche to avoid potential OC-related effects on bone growth prior to menarche * At risk of suicide. To be considered "at suicide risk" participants must meet the following-Mood and Feelings Questionnaire score of ≥ 27 Exclusion Criteria: * Personal history of metabolic or autoimmune disease * Epilepsy * Endometriosis * Cardiovascular, gastrointestinal, hepatic, renal, or pulmonary disease Diabetes mellitus with vascular disease * Uncontrolled hypertension * Liver tumors (benign or malignant) or liver disease * Undiagnosed abnormal uterine bleeding * Headaches with focal neurological symptoms or migraine with aura * Known or suspected pregnancy * Current or past deep vein thrombosis or pulmonary embolism * Cerebrovascular disease Coronary artery disease * Thrombogenic valvular or rhythm disease (e.g., subacute bacterial endocarditis with valvular disease, atrial fibrillation) * Inherited or acquired hypercoagulopathies * Current or history of breast cancer or other hormone-sensitive malignancy * Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir * Personal or first-degree relative with breast cancer or thromboembolic events

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

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

Depression - major depressive disorder Irritability

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Biomedical Research Imaging Center (BRIC) at UNC

    Chapel Hill, North Carolina, 27517, United States

  • Carolina Crossing

    Chapel Hill, North Carolina, 27517, United States

More trials for these conditions

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