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Teen Vulnerability to Irritability: Brain and Estrogen Changes

Neurobiological Mechanisms of Susceptibility to Estradiol Fluctuation in Female Adolescents at Risk of Suicide: An Experimental Approach

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 16 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants: The investigators will enroll 50 female adolescents ages 12-16 who are at risk of suicide (i.e., moderate depressive symptoms), and are eligible to receive oral contraceptives and undergo MRI imaging."
  • "Each condition will include: 1) daily samples of E2 and P4 urinary metabolites, 2) daily symptom ratings(e.g., irritability, negative affect and suicidal thoughts and behaviors (STBs)), and 3) a neuroimaging session with MRI and magnetic resonance spectroscopy (MRS)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how changes in estrogen and progesterone, two hormones, affect the brain, irritability, and depression symptoms. It is for teens ages 12–16 assigned female at birth who have started their periods and are at risk of suicide. Each teen will take birth control pills for 8 weeks and pills with no active medicine for 8 weeks, and have brain scans.

Purpose: Risk of severe psychopathology increases dramatically during adolescence, especially for females. Changes in ovarian steroids across the menstrual cycle produce windows of vulnerability to mood disturbances, particularly during the abrupt withdrawal of estradiol (E2) and progesterone (P4) prior to menses onset. Irrefutable evidence links stress with affective symptoms, potentially mediated by E2-related modifications of frontolimbic connectivity and prefrontal gamma-aminobutyric acid (GABA) inhibitory signaling. The primary objective of this project is to empirically test the impact of E2 and P4 change on vulnerable brain networks associated with irritability and other depressive symptoms in female adolescents at risk of suicide. Participants: The investigators will enroll 50 female adolescents ages 12-16 who are at risk of suicide (i.e., moderate depressive symptoms), and are eligible to receive oral contraceptives and undergo MRI imaging. Procedure: Using a randomized, placebo-controlled, cross-over design, participants will be studied under two conditions: 8 weeks of E2 and P4 stabilization (continuous combined oral contraceptive (COC) to prevent perimenstrual withdrawal) and 8 weeks of placebo, with a 1-month washout after each condition. Each condition will include: 1) daily samples of E2 and P4 urinary metabolites, 2) daily symptom ratings(e.g., irritability, negative affect and suicidal thoughts and behaviors (STBs)), and 3) a neuroimaging session with MRI and magnetic resonance spectroscopy (MRS).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Assigned female at birth and age 12–16.
  • Able to take low-dose birth control pills.
  • Have started having periods.
  • At risk of suicide, defined here as a score of 27 or higher on the Mood and Feelings Questionnaire.

Who can't join

  • A history of a metabolic disease (how the body uses food for energy) or an autoimmune disease (when the body attacks itself); epilepsy, a seizure disorder.
  • Endometriosis (tissue like the womb lining grows outside the womb); unexplained abnormal bleeding from the womb; known or possible pregnancy.
  • Disease of the heart, blood vessels, digestive system, liver, kidneys, or lungs; diabetes with blood vessel damage; uncontrolled high blood pressure; liver tumors.
  • Headaches with nerve symptoms, or migraines with aura, such as flashing lights.
  • Current or past clots in deep veins or the lungs; blood vessel disease in the brain; heart artery disease; heart valve or rhythm problems that can cause clots; conditions that make blood clot too easily.
  • Current or past breast cancer or another cancer affected by hormones.
  • A personal history, or a parent, sibling, or child with a history, of breast cancer or blood clots.
  • Taking hepatitis C medicines containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (2)

NC