Actively Recruiting

Age: 8Years - 17Years
FEMALE
Healthy Volunteers
ID06690866

Negative Emotionality in Relation to Epigenetics of Estrogen Signaling During Puberty

Led by International Research Training Group 2804 · Updated on 2024-11-15

100

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

I

International Research Training Group 2804

Lead Sponsor

U

University Hospital Tuebingen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how changes during puberty affect gene activity and emotional responses in girls. The study focuses on the interaction of epigenetics, hormones, and brain processes that may explain why mental health issues become more common in females after puberty. It aims to understand how estrogen-related gene changes link to stress and feelings of depression during this developmental stage. The study enrolls 100 healthy girls, split into two groups: 50 pre-pubertal girls aged 8 to 10 at pubertal stage 1, and 50 post-pubertal girls aged 15 to 17 at pubertal stage 5. Participants complete questionnaires on puberty, stress, mood, and health, and undergo brain scans and the Montreal Imaging Stress Task (MIST) to study brain and stress responses. Blood, saliva, and hair samples are collected to analyze hormones, DNA methylation, and gene expression related to estrogen signaling. Participants are involved in self- and parent-reported assessments, brain MRI scans, stress testing, and biological sample collection. Researchers measure DNA methylation differences, brain activity during stress, hormone levels, and emotional responses. They also evaluate how these factors relate to gene expression and brain structure. The study includes repeated saliva samples for cortisol and stress ratings, and tracks physiological stress markers like heart rate. The total study time includes MRI sessions, questionnaires, and biological sample collection.

CONDITIONS

Brief Title

Negative Emotionality and Epigenetics During Puberty

Who Can Participate

Age: 8Years - 17Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy girls
  • Aged 8 to 10 years with pubertal stage 1 or aged 15 to 17 years with pubertal stage 5
  • Normal body mass index for age (between 5th and 85th percentile)
  • Non-smoking
  • Fluent in German
  • Attending age-appropriate schools
Not Eligible

You will not qualify if you...

  • Neurological or psychiatric disease
  • Hormonal, metabolic, developmental, or chronic medical problems (e.g., congenital disorders, precocious puberty, polycystic ovarian syndrome, diabetes, congestive heart failure)
  • Hormonal, pharmacological, or psychotropic treatment within the last three months
  • Participation in competitive or extreme sports
  • Non-removable metal objects on or in the body
  • Tattoos not compatible with MRI
  • Hearing problems or sensitivity to loud noises
  • Claustrophobia
  • Surgery within the last three months
  • Moderate or severe head injury

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants provide questionnaire data on pubertal status, prenatal complications, adverse life events, stress and coping mechanisms, mood and anxiety symptoms, gender identity, and reproductive health. They also provide blood, saliva, and hair samples for hormone, methylation, and expression analysis.

1 visit (in-person)

Imaging and Stress Testing

Duration - 1 day

Participants undergo functional and structural MRI scans including resting-state and MPRAGE MRI, and complete the Montreal Imaging Stress Task (MIST) to assess neuronal correlates of acute psychosocial stress. Physiological stress responses such as heart rate and skin conductance are measured during this time.

1 visit (in-person)

Observational Monitoring

Duration - Approximately 2 hours on the day of imaging and stress testing

Participants provide multiple saliva samples before, during, and after the stress task to assess cortisol levels and subjective stress responses over time.

6 saliva collections during 1 visit

Trial Site Locations

Total: 1 location

1

University of Tuebingen; Department of Psychiatry & Psychotherapy; Tuebingen

Tübingen, Baden-Wurttemberg, Germany, 72076

Actively Recruiting

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Research Team

V

Vanessa Nieratschker, Prof. Dr.

B

Birgit Derntl, Prof. Dr.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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