Investigating emotional changes and genetics during puberty in girls
Negative Emotionality in Relation to Epigenetics of Estrogen Signaling During Puberty
This study is trying to see how hormonal changes during puberty affect emotions in girls by looking at their genes and stress levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | Female |
| Sponsor | International Research Training Group 2804 Academic / other |
| Locations | 1 site (Tübingen, Baden-Wurttemberg) |
| Trial ID | NCT06690866 on ClinicalTrials.gov |
What this trial studies
This observational study examines the relationship between epigenetics and negative emotionality during puberty in healthy girls. It enrolls 50 pre-pubescent girls aged 8-10 and 50 post-pubescent girls aged 15-17, collecting data through questionnaires, neuroimaging (fMRI), and physiological stress assessments. Blood, saliva, and hair samples will be analyzed for hormone levels, DNA methylation, and gene expression related to stress and emotional responses. The goal is to understand how hormonal changes during puberty may influence mental health outcomes in females.
Who should consider this trial
Good fit: Ideal candidates are healthy girls aged 8-10 in early puberty or 15-17 in late puberty with normal body mass index.
Not a fit: Patients with neurological or psychiatric disorders, chronic medical conditions, or those undergoing hormonal treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the biological factors contributing to increased mental health issues in females during puberty.
How similar studies have performed: While the specific interactions of epigenetics and emotionality during puberty are less explored, related studies have shown promising results in understanding hormonal influences on mental health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * healthy girls * aged between 8-10 and having pubertal stage 1 or between 15-17 and having pubertal stage 5 * normal body mass index according to age (between 5th and 85th percentile) * non-smoking * German language fluency * Attending age-appropriate schools Exclusion Criteria: * neurological or psychiatric disease * medical problems such as hormonal, metabolic, developmental or chronic diseases (e.g., congenital disorders, precocious puberty, polycystic ovarian syndrome, diabetes or congestive heart failure) * any kind of hormonal, pharmacological or psychotropic treatment in the last three months * engaging in competitive/extreme sports Additional exclusion criteria for MRI: * People with non-removable metal objects on or in the body * Tattoos (if not MRI-incompatible according to expert guidelines) * Pathological hearing or increased sensitivity to loud noises * Claustrophobia * Surgery less than three months ago * Moderate or severe head injury
Where this trial is running
Tübingen, Baden-Wurttemberg
- University of Tuebingen; Department of Psychiatry & Psychotherapy; Tuebingen — Tübingen, Baden-Wurttemberg, Germany (Recruiting)
Study contacts
- Principal investigator: Vanessa Nieratschker, Prof. — University Hospital Tuebingen
- Study coordinator: Vanessa Nieratschker, Prof. Dr.
- Email: vanessa.nieratschker@med.uni-tuebingen.de
- Phone: +497071-2985523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.