Monitoring metabolic side effects of antipsychotics in children
Monitoring of Metabolic Adverse Events of Second Generation Antipsychotics in a Naive Pediatric Population Followed in Mental Health Outpatient and Inpatient Clinical Settings (MEMAS Prospective Study)
St. Justine's Hospital · NCT04395326
This study is trying to see how different factors affect the metabolic side effects in children taking new antipsychotic medications over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | St. Justine's Hospital (other) |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT04395326 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the metabolic adverse events associated with second generation antipsychotics (SGAs) in a naïve pediatric population. It will investigate various factors such as age, ethnicity, and dosage that may influence the development of these metabolic side effects. The study will follow participants for up to 24 months, monitoring their metabolic health according to established guidelines. The research is being conducted at multiple centers, including CHU Sainte-Justine Hospital and CIUSSS NIM.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years who are starting treatment with second generation antipsychotics for the first time.
Not a fit: Patients with pre-existing metabolic conditions such as diabetes or dyslipidemia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of metabolic side effects in children prescribed SGAs.
How similar studies have performed: While there have been studies on metabolic side effects of SGAs, this specific approach focusing on a naïve pediatric population and adherence to monitoring guidelines is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients under 18 years of age, * previously AP-naifs, * starting an SGA or who started an SGA for less than 4 weeks, * followed longitudinally at one of the selected recruiting center, * regardless of the diagnosis that motivated the prescription of the SGA medication. Exclusion Criteria: * diabetes, * dyslipidemia, * high blood pressure, * thyroid dysfunction, * hepatic disease, * hyperprolactinemia, * taking a medication to treat any of the above conditions before starting SGA treatment and pregnancy.
Where this trial is running
Montréal, Quebec
- Ben Amor Leila — Montréal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Drigissa Ilies, MD, MSC — Rivières des Praires Hospital
- Study coordinator: Leila Ben Amor, MD, MSc
- Email: leila.ben.amor.hsj@ssss.gouv.qc.ca
- Phone: (1) 514 345 4931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adverse Drug Event, metabolic side effects, naïve pediatric population, second generation antipsychotics, predictive factors, monitoring