Evaluating gene expression changes in children on antipsychotic medications

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

This study is trying to see how antipsychotic medications affect the genes of children and teens with metabolic disorders, compared to those who don't take these medications, to find early signs of possible health issues.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 5 Years to 17 Years
• Sex: All
• Sponsor: IRCCS Eugenio Medea (other)
• Locations: 1 site (Bosisio Parini, LC)
• Trial ID: NCT06814314 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 5-17 who are either using antipsychotics with metabolic disorders, using antipsychotics without metabolic disorders, or not using antipsychotics but have metabolic disorders.

Not a fit: Patients with diagnosed genetic conditions that affect energy metabolism or nutrition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the identification of biomarkers that help predict metabolic disorders in patients treated with antipsychotics, enhancing patient care.

How similar studies have performed: While there is existing literature on the metabolic effects of antipsychotics, this specific approach of using transcriptomics to identify biomarkers is relatively novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Bosisio Parini, LC

• IRCCS Eugenio Medea — Bosisio Parini, LC, Italy (RECRUITING)

Study contacts

• Study coordinator: Marco Pozzi, PhD

Conditions: Neurodevelopmental Disorders, Irritability, antipsychotic drugs, dyslipidemia, pre-diabetes, obesity, transcriptomics