Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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)
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
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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