Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07544966 · ClinicalTrials.gov registry record · Phase 4
Teen Vulnerability to Irritability: Brain and Estrogen Changes
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Not yet
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT07544966 is a Phase 4 study that has not yet begun recruiting, run by University of North Carolina, Chapel Hill. The registered enrollment target is 50 participants.
The verdict
NCT07544966, a Phase 4 study, has not yet begun recruiting, sponsored by University of North Carolina, Chapel Hill.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study Summary
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).
Interventions
- DRUG Kurvelo
- DRUG Placebo COC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2029-04 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07544966
The ClinicalTrials.gov registry entry for NCT07544966 describes a study currently listed as not yet recruiting, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Kurvelo is the first listed.
NCT07544966 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07544966 about?
NCT07544966 is a clinical study titled "Teen Vulnerability to Irritability: Brain and Estrogen Changes". 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) p...
What is the current status of trial NCT07544966?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2026-06-01. Estimated completion is 2029-04.
What interventions are being tested in trial NCT07544966?
The interventions under investigation include: Kurvelo (DRUG), Placebo COC (DRUG).
Who is sponsoring clinical trial NCT07544966?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.