NCT06690866 Negative Emotionality and Epigenetics During Puberty
| NCT ID | NCT06690866 |
| Status | Recruiting |
| Phase | — |
| Sponsor | International Research Training Group 2804 |
| Condition | Puberty |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-26 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-03-26 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pubertal transition leads to enduring neuroendocrine changes along with changes in the epigenome. The prevalence of psychiatric disorders significantly increases in females compared to males after puberty. There is likely to be an interaction between epigenetics, hormones and neurophysiological processes during puberty, leading to the increased prevalence of mental disorders in females. This study aims to shed light on these interactions underlying the emerging sex differences after puberty. Specifically, it seeks to investigate the epigenetic modifications and subsequent changes in gene expression during the pubertal transition and their association with negative emotionality (e.g., acute stress response and depressive symptoms) at molecular, neuronal, subjective and physiological levels.
Eligibility 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
Contact & Investigator
Vanessa Nieratschker, Prof.
PRINCIPAL INVESTIGATOR
University Hospital Tuebingen
Frequently Asked Questions
Who can join the NCT06690866 clinical trial?
This trial is open to female participants only, aged 8 Years or older, up to 17 Years, studying Puberty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06690866 currently recruiting?
Yes, NCT06690866 is actively recruiting participants. Contact the research team at vanessa.nieratschker@med.uni-tuebingen.de for enrollment information.
Where is the NCT06690866 trial being conducted?
This trial is being conducted at Tübingen, Germany.
Who is sponsoring the NCT06690866 clinical trial?
NCT06690866 is sponsored by International Research Training Group 2804. The principal investigator is Vanessa Nieratschker, Prof. at University Hospital Tuebingen. The trial plans to enroll 100 participants.