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Набор скоро начнётся NCT07544966

Teen Vulnerability to Irritability: Brain and Estrogen Changes

Фаза IV С лечением Depression - Major Depressive Disorder Irritability

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Kurvelo, Placebo COC.
Кому может быть актуально
Состояния в реестре: Depression - Major Depressive Disorder, Irritability. Базовые параметры: 12 лет — 16 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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).

Вмешательства

  • Препарат Kurvelo
    Kurvelo®: 30mcg ethinyl estradiol (EE) and 0.15mg levonorgestrel (LNG), a synthetic estrogen and progestin, respectively.
  • Препарат Placebo COC
    Placebo pills from the Kurvelo® packages (cut from package to maintain blinding).

Первичные конечные точки

  • Irritability Symptoms (average Brief Irritability Test (BITe) across each 8-week condition) [Срок оценки: Average Brief Irritability Test (BITe) will be collected daily across the complete study duration (week 1 -24).]
Вторичные конечные точки (3)
  • Irritable behavior (point subtraction aggression paradigm (PSAP) [Срок оценки: During the neuroimaging session (inside the scanner) at week 8 (1 time point during the last week of condition 1) and week 20 (1 time point during the last week of condition 2)]
  • medial prefrontal cortex GABAergic activity [Срок оценки: During the neuroimaging session (inside the scanner) at week 8 (1 time point during the last week of condition 1) and week 20 (1 time point during the last week of condition 2)]
  • Functional connectivity between amygdala and frontal network (medial, ventrolateral, ventromedial prefrontal cortex). [Срок оценки: During the neuroimaging session (inside the scanner) at week 8 (1 time point during the last week of condition 1) and week 20 (1 time point during the last week of condition 2)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 2 центра
  • Biomedical Research Imaging Center (BRIC) at UNC — Chapel Hill
  • Carolina Crossing — Chapel Hill

Идентификаторы

NCT: NCT07544966 · 25-2243

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗