| NCT ID | NCT06814314 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Eugenio Medea |
| Condition | Neurodevelopmental Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-04-30 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-04-30 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06814314 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 17 Years, studying Neurodevelopmental Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06814314 currently recruiting?
Yes, NCT06814314 is actively recruiting participants. Contact the research team at marco.pozzi@lanostrafamiglia.it for enrollment information.
Where is the NCT06814314 trial being conducted?
This trial is being conducted at Bosisio Parini, Italy.
Who is sponsoring the NCT06814314 clinical trial?
NCT06814314 is sponsored by IRCCS Eugenio Medea. The trial plans to enroll 100 participants.