NCT07544966Not yet recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 2 Feb 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Depression
- NCT number
- NCT07544966
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From 1 Oct 2026 to the primary completion date, 30 Apr 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Personal history of metabolic or autoimmune disease
- Epilepsy
- 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
- 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)
- 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
Other
- Endometriosis
- Headaches with focal neurological symptoms or migraine with aura
- Known or suspected pregnancy
- Inherited or acquired hypercoagulopathies
Who the study is looking for
- 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
Age in the registry: 12 years to 16 years · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Carolina Crossing Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Biomedical Research Imaging Center (BRIC) at UNC Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.