NCT06814314Recruiting
AP Metabolism Transcriptomics
Pilot Study of Transcriptomic Alterations Associated with Antipsychotic-induced Metabolic Disorders in Children and Adolescents
Source: ClinicalTrials.gov · Last updated 7 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 3 Feb 2025
- Start date
- 30 Apr 2023
- Primary completion date
- May 2026
- Lead sponsor
- IRCCS Eugenio Medea
- Diseases
- Obesity
- NCT number
- NCT06814314
What you commit to
- Study type: Observational
- Planned participants: 100
- From 30 Apr 2023 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- concomitant use of drugs known to alter energy metabolism and/or nutrition.
Other illness
- presence of diagnosed genetic conditions known to alter energy metabolism and/or nutrition;
- presence of diagnosed eating disorders;
Other
- habitual use of supplements known to alter energy metabolism and/or nutrition;
Who the study is looking for
- 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.
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Eugenio Medea Coordinator of this site? Confirm its status | Bosisio Parini | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.