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NCT Number: NCT06814314

AP Metabolism Transcriptomics

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.

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Key information

Conditions

Neurodevelopmental Disorders Body Weight Dyslipidemias Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Irritability Lipid Metabolism Disorders Mental Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Eugenio Medea

Bosisio Parini, LC, 23842, Italy

Location status: Recruiting

Location contact

Marco Pozzi, PhD

CONTACT

[email protected]

031877919 ext. +39

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcriptomic investigation

Diagnostic Test

Transcriptomic investigation followed by ontology classification

Primary outcomes

BMI-Z

Time frame: Once, at recruitment

Body mass index, normalized by age and sex. Values below -1 indicate underweight, values below 1 indicate overweight.

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Pozzi, PhD

CONTACT

[email protected]

031877919 ext. +39

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Feb 7, 2025
Registry last updated: Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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