Pilot Study on Gene Activity Changes Linked to Antipsychotic-Related Metabolic Issues in Children and Teens aged 5 to 17

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.

AP Metabolism Transcriptomics