Evaluating gene expression changes in children on antipsychotic medications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the transcriptomic profiles of children and adolescents aged 5-17 who are undergoing treatment with antipsychotic drugs and exhibit metabolic disorders. It will compare these profiles with those of similar patients who do not use antipsychotics but have metabolic disorders, as well as those who use antipsychotics without metabolic disorders. The goal is to identify distinct transcriptomic markers that could serve as early indicators of metabolic complications due to antipsychotic treatment, potentially improving management strategies for these therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* age 5-17 years;
* group 1: antipsychotic users with metabolic disorders;
* group 2: antipsychotic users without metabolic disorders;
* group 3: non-antipsychotic users with metabolic disorders. The definition of antipsychotic use includes daily use for at least 3 months prior to enrollment.

The definition of metabolic disorders includes: BMI-Z for age, sex and height \> +1 Waist circumference \> 90th percentile for age, sex and height Diastolic or systolic blood pressure \> 90th percentile for age, sex and height Fasting blood glucose \> 99 mg/dl Fasting triglycerides \> 149 mg/dl Fasting cholesterol \< 41 mg/dl.

Patients with metabolic disorders are defined as those who meet at least one of the above criteria.

Patients without metabolic disorders are defined as those who do not present any of the above criteria.

Exclusion Criteria:

* presence of diagnosed genetic conditions known to alter energy metabolism and/or nutrition;
* presence of diagnosed eating disorders;
* habitual use of supplements known to alter energy metabolism and/or nutrition;
* concomitant use of drugs known to alter energy metabolism and/or nutrition.

Where it's running

• IRCCS Eugenio Medea
  Bosisio Parini, Lc, Italy Recruiting

Study contacts

• Study coordinator: Marco Pozzi, PhD
• Email: marco.pozzi@lanostrafamiglia.it
• Phone: 031877919

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.