Actively Recruiting
Pilot Study of Transcriptomic Alterations Associated with Antipsychotic-induced Metabolic Disorders in Children and Adolescents
Led by IRCCS Eugenio Medea · Updated on 2025-02-07
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the changes in gene activity related to metabolic disorders in children and adolescents with neurodevelopmental disorders and irritability who are treated with antipsychotic drugs. The study aims to compare gene expression patterns in three groups: those using antipsychotics with metabolic disorders, those using antipsychotics without metabolic disorders, and those with metabolic disorders not using antipsychotics. The goal is to identify early genetic markers that might predict the development of metabolic problems linked to antipsychotic treatment, which could help personalize therapy and reduce metabolic risks. Participants are divided into three groups based on their antipsychotic use and metabolic health status. The study involves a transcriptomic investigation, which examines gene activity from blood samples, followed by classification of these gene patterns. This observational study does not involve experimental treatment but focuses on understanding the biological changes associated with antipsychotic use and metabolic conditions. During the study, each participant will have their body mass index adjusted for age, sex, and height (BMI-Z) measured once at recruitment. Researchers will analyze gene expression in peripheral blood mononuclear cells to identify differences among the groups. The trial is led by IRCCS Eugenio Medea and includes children and adolescents aged 5 to 17 years. The study will continue until May 2026, with assessments focusing on metabolic and genetic markers relevant to antipsychotic treatment outcomes.
CONDITIONS
Brief Title
AP Metabolism Transcriptomics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 5 and 17 years
- Use antipsychotic drugs daily for at least 3 months and have metabolic disorders
- Use antipsychotic drugs daily for at least 3 months and do not have metabolic disorders
- Have metabolic disorders but do not use antipsychotic drugs
- Metabolic disorders defined as meeting at least one of the following: BMI-Z above +1, waist circumference above 90th percentile, blood pressure above 90th percentile, fasting blood glucose over 99 mg/dl, fasting triglycerides over 149 mg/dl, or fasting cholesterol below 41 mg/dl
You will not qualify if you...
- Diagnosed genetic conditions that alter energy metabolism or nutrition
- Diagnosed eating disorders
- Regular use of supplements that affect energy metabolism or nutrition
- Use of medications known to affect energy metabolism or nutrition
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.
Duration - Once at recruitment
Participants undergo transcriptomic investigation followed by ontology classification to assess metabolic status.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
IRCCS Eugenio Medea
Bosisio Parini, LC, Italy, 23842
Actively Recruiting
Research Team
M
Marco Pozzi, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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