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AP Metabolism Transcriptomics

NCT06814314 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-02-07

No results posted yet for this study

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

DIAGNOSTIC_TEST

Transcriptomic investigation

Transcriptomic investigation followed by ontology classification

Sponsors & Collaborators

  • IRCCS Eugenio Medea

    lead OTHER

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06814314 on ClinicalTrials.gov