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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: Clinical Trial Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The Brief Irritability Test (BITe) is a 5-item self-report instrument developed to measure irritability as a distinct emotional construct, defined by increased susceptibility to frustration, annoyance, and anger in response to minimal provocation. Participants rate each item (e.g., feeling grumpy, easily annoyed, on edge) using a 6-point Likert scale ranging from Never (1) to Always (6). Total scores range from 5 to 30, with higher scores indicating greater irritability. BITe total score is calc
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 |
What is known before NCT07544966 opens enrollment
NCT07544966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Kurvelo is the first listed.
NCT07544966 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT07544966's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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