Teen Vulnerability to Irritability: Brain and Estrogen Changes (NCT07544966)
Summary
NIH registered a Phase 4 clinical trial (NCT07544966) titled "Teen Vulnerability to Irritability: Brain and Estrogen Changes," enrolling 50 female adolescents ages 12-16 at risk of suicide. The randomized, placebo-controlled, cross-over study will test the impact of estradiol (E2) and progesterone (P4) stabilization via continuous combined oral contraceptive (Kurvelo) versus placebo on brain networks associated with irritability over two 8-week treatment arms. Each participant undergoes daily hormone sampling, daily symptom ratings, and neuroimaging sessions across conditions.
“Risk of severe psychopathology increases dramatically during adolescence, especially for females.”
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What changed
NIH has registered a new Phase 4 clinical trial (NCT07544966) on ClinicalTrials.gov describing a randomized, placebo-controlled, cross-over study of estrogen and progesterone stabilization in female adolescents at risk of suicide. The trial will enroll 50 participants ages 12-16 and compare 8 weeks of continuous combined oral contraceptive (Kurvelo) against placebo, with neuroimaging and daily symptom monitoring. This registry entry documents study parameters and does not impose regulatory obligations on healthcare providers, pharmaceutical companies, or clinical investigators beyond standard clinical trial conduct requirements.
Affected parties—including clinical investigators conducting adolescent psychiatry research, institutional review boards reviewing similar protocols, and manufacturers of combined oral contraceptives—should note this trial's specific focus on perimenstrual hormone withdrawal as a window of vulnerability for mood disturbances. The trial's primary endpoint targets irritability and depressive symptoms mediated by frontolimbic connectivity and prefrontal GABA signaling.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Teen Vulnerability to Irritability: Brain and Estrogen Changes
Phase 4 NCT07544966 Kind: PHASE4 Apr 22, 2026
Abstract
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 MR...
Conditions: Depression - Major Depressive Disorder, Irritability
Interventions: Kurvelo, Placebo COC
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