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Teen Vulnerability to Irritability: Brain and Estrogen Changes

This study is looking at how changes in hormones like estrogen (E2) and progesterone (P4) might affect irritability and depression in teenage girls who are at risk of suicide. Researchers want to understand how these hormone changes impact brain networks linked to mood. You would receive either Kurvelo®, a birth control pill containing synthetic estrogen and progestin, or a placebo (an inactive pill that looks the same). The main goal is to measure changes in irritability symptoms using a daily test called the Brief Irritability Test (BITe) over 24 weeks. This study is for girls aged 12 to 16 who have started their periods and are eligible to take a low-dose oral contraceptive. The current status of this study is unclear, and it plans to enroll 50 participants.

Study design
This is an interventional study comparing Kurvelo® to a placebo. It plans to enroll 50 female participants aged 12-16.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Irritability symptoms will be measured daily across the complete study duration (week 1 - 24).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07544966

Teen Vulnerability to Irritability: Brain and Estrogen Changes

Not Yet Recruiting
PHASE4Ages 12–16InterventionalBasic science
University of North Carolina, Chapel Hill
~50 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:KurveloPlacebo COC

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Irritability Symptoms (average Brief Irritability Test (BITe) across each 8-week condition)
Measured over Average Brief Irritability Test (BITe) will be collected daily across the complete study duration (week 1 -24).

Conditions

Depression - Major Depressive Disorder
Irritability

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Where it's being run

2 sites across 1 states
North Carolina2

Study leadership

  • Elizabeth Andersen, PhD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

Elizabeth Andersen, PhD
[email protected]
(919) 843-8084
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Irritability Symptoms (average Brief Irritability Test (BITe) across each 8-week condition)Average Brief Irritability Test (BITe) will be collected daily across the complete study duration (week 1 -24).

    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 calculated as the sum of the five items.