Investigating emotional changes and genetics during puberty in girls

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.