Neurodevelopmental DisordersNCT06814314
AP Metabolism Transcriptomics
An observational study of Neurodevelopmental Disorders and Irritability, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Neurodevelopmental Disorders, Irritability
- What is being tested?
- Transcriptomic investigation
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2023to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Persons with metabolic syndrome and/or users of antipsychotic drugs
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Eugenio Medea
Bosisio Parini, LC, 23842
Marco Pozzi, PhD, 031877919 ext. +39, marco.pozzi@lanostrafamiglia.it
About this study
Official title: Pilot Study of Transcriptomic Alterations Associated with Antipsychotic-induced Metabolic Disorders in Children and Adolescents
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.
- Conditions
- Neurodevelopmental Disorders, Irritability
- Being tested
- Transcriptomic investigation
- Keywords
- antipsychotic drugs, dyslipidemia, pre-diabetes, obesity, transcriptomics
- Medical subject headings
- Neurodevelopmental Disorders, Dyslipidemias, Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcriptomic investigationDiagnostic test
Transcriptomic investigation followed by ontology classification
| Study group | Role | What they receive |
|---|---|---|
| AP+ / MetS+ | Persons using antipsychotic drugs and meeting diagnostic criteria for the metabolic syndrome Receives: Diagnostic Test: Transcriptomic investigation | |
| AP+ / MetS- | Persons using antipsychotic drugs not meeting diagnostic criteria for the metabolic syndrome Receives: Diagnostic Test: Transcriptomic investigation | |
| AP- / MetS+ | Persons meeting diagnostic criteria for the metabolic syndrome not using antipsychotic drugs Receives: Diagnostic Test: Transcriptomic investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI-Z
Body mass index, normalized by age and sex. Values below -1 indicate underweight, values below 1 indicate overweight.
Measured: Once, at recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start30 Apr 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814314
- Sponsor's protocol ID
- 9/24 (ex 995)
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Transcriptomic Alterations Associated with Antipsychotic-induced Metabolic Disorders in Children and Adolescents
- ClinicalTrials.gov ID
- NCT06814314
- Acronym / sponsor ID
- 9/24 (ex 995)
- Conditions
- Neurodevelopmental Disorders, Irritability
- Keywords
- antipsychotic drugs, dyslipidemia, pre-diabetes, obesity, transcriptomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AP+ / MetS+ | – | Diagnostic Test: Transcriptomic investigationPersons using antipsychotic drugs and meeting diagnostic criteria for the metabolic syndrome |
| AP+ / MetS- | – | Diagnostic Test: Transcriptomic investigationPersons using antipsychotic drugs not meeting diagnostic criteria for the metabolic syndrome |
| AP- / MetS+ | – | Diagnostic Test: Transcriptomic investigationPersons meeting diagnostic criteria for the metabolic syndrome not using antipsychotic drugs |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Persons with metabolic syndrome and/or users of antipsychotic drugs
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcriptomic investigationTranscriptomic investigation followed by ontology classification | Diagnostic test | AP+ / MetS+, AP+ / MetS-, AP- / MetS+ |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Disorders and Irritability, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Pozzi, PhD (031877919 ext. +39, marco.pozzi@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI-Z (time frame: Once, at recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.