NCT06814314

AP Metabolism Transcriptomics

Pilot Study of Transcriptomic Alterations Associated with Antipsychotic-induced Metabolic Disorders in Children and Adolescents

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: IRCCS Eugenio Medea · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

It is known from the literature that treatment with antipsychotic drugs (AP) induces, even before changes in blood chemistry parameters, changes in gene transcription that are evident at the level of peripheral blood mononuclear cells. In this pilot study we intend to evaluate the transcriptomic profile of children and adolescents who are undergoing treatment with antipsychotics and show metabolic disorders, in order to compare it to the profile of similar patients who do not use antipsychotics, but show metabolic disorders, or who use antipsychotics, but do not show metabolic disorders. The hypothesis is that a different transcriptomic profile can be identified between the three populations under study, such as to allow to hypothesize that a series of transcripts can be used as early biomarkers of whether treatment with antipsychotics can induce metabolic disorders in the individual patient or not. This information could be used to improve the management of antipsychotic therapies in the direction of personalized medicine, reducing metabolic risks.

Conditions

• Neurodevelopmental Disorders
• Irritability

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Transcriptomic investigation	Transcriptomic investigation followed by ontology classification

Timeline

• Start date: 2023-04-30
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-02-07
• Last updated: 2025-02-07

Locations

1 site across 1 country: Italy