scholarly journals Monitoring of metabolic adverse events of second-generation antipsychotics in a naive paediatric population followed in mental health outpatient and inpatient clinical settings: MEMAS prospective study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e040764
Author(s):  
Marie-Line Menard ◽  
Drigissa Ilies ◽  
Pascale Abadie ◽  
Thaïna Jean-Baptiste ◽  
Rachel Choquette ◽  
...  

IntroductionSecond-generation antipsychotics (SGAs) are widely used in the paediatric population. It is currently established that SGAs may induce metabolic adverse events (AEs) such as weight gain, perturbation of blood lipids or glucose with risk of potential cardiovascular morbidity and mortality. The Canadian Alliance for Monitoring Effectiveness and Safety of Antipsychotics in children (CAMESA) has published recommendations for monitoring the metabolic AEs of SGAs. Factors that may be associated with the onset of SGA’s metabolic AEs and long-term consequences are less studied in the literature. The objectives of our research are to evaluate some factors that can influence the development of the SGA’s metabolic AEs and to study clinical adherence to CAMESA guidelines.Methods and analysisThe Monitoring des Effets Métaboliques des Antipsychotiques de Seconde Génération study is a multicenter, prospective, longitudinal observational study with repeated measures of metabolic monitoring over 24 months. Two recruiting centres have been selected for patients under 18 years of age, previously naive of antipsychotics, starting an SGA or who have started an SGA for less than 4 weeks regardless of the diagnosis that motivated the prescription. Assessments are performed for anthropometric measures, blood pressure, blood tests at baseline and 1, 2, 3, 6, 9, 12 and 24 months of follow-up.Ethics and disseminationThe study protocol was approved by the CHU Sainte-Justine’s Research Ethics Board (MP-21-2016-1201) in 2016 and obtained institutional suitability for the ‘Centre Intégré Universitaire de Santé et de Services Sociaux du Nord-de-l’Île-de-Montréal’ Research Center in May 2018. For all participants, written consent will be obtained from parents/caregivers as well as the participant’s assent in order to enable their participation in this research project. The results of this research will be published.Trial registration numberClinicalTrials.gov (number NCT04395326).

2006 ◽  
Vol 15 (1) ◽  
pp. 177-206 ◽  
Author(s):  
Christoph U. Correll ◽  
Julie B. Penzner ◽  
Umesh H. Parikh ◽  
Tahir Mughal ◽  
Tariq Javed ◽  
...  

2020 ◽  
pp. 070674372097484
Author(s):  
Sarra Jazi ◽  
Leila Ben-Amor ◽  
Pascale Abadie ◽  
Marie-Line Menard ◽  
Rachel Choquette ◽  
...  

Objective: The potential metabolic adverse effects of second-generation antipsychotics (SGA) need to be monitored. The Canadian Alliance for Monitoring Effectiveness and Safety of Antipsychotics (CAMESA) offers guidelines for this purpose. We aimed to evaluate the long-term rates of youths receiving monitoring in mental health clinics and document the factors that may influence them. Method: The charts of 180 patients (13.3 ± 3.1 years, 54.4% males) receiving SGA treatment for the first time between January 2016 and June 2018 were reviewed. Monitoring was divided into baseline and 1- to 6-month and 9- to 24-month periods. Population under study was stratified into children (4 to 12 years) and adolescents (13 to 18 years). Sociodemographic characteristics, psychiatric diagnosis and comorbidities, prescribed SGAs and comedications, anthropometric measures (AM), blood pressure (BP), blood tests (BT), electrocardiogram, and the psychiatrist’s years of practice were collected. Cross tables were used to present the monitoring rates. Categories were compared by covariate analysis. Rates of patients monitored across categories were compared using Fisher exact test. Results: Monitoring rates for AM, BT, and BP were 55%, 47.8%, and 46.7% at baseline; 50%, 41.7%, and 45.2% at 1 to 6 months; and 47.2%, 41.5%, and 40.6% at 9 to 24 months, respectively. Higher monitoring rates were significantly associated with adolescent status (baseline, 1 to 6 months), a diagnosis of psychotic and/or affective disorder (baseline, 1 to 6 months, 9 to 24 months), having ≤1 psychiatric comorbidities (1 to 6 months), high SGA dose (baseline, 1 to 6 months), and clinician’s experience (baseline, 9 to 24 months). Significantly lower monitoring rates were associated with the psychostimulant/atomoxetine comedication (baseline, 1 to 6 months, 9 to 24 months). Conclusion: Five years after publication of the CAMESA guidelines, metabolic monitoring is conducted for less than half of patients. In our sample, age, diagnostic category, psychiatric comorbidities, SGA dose, clinician’s experience, and comedications influenced the monitoring rates. Major progress still needs to be made before reaching a satisfactory level of monitoring.


2011 ◽  
Vol 26 (3) ◽  
pp. 144-158 ◽  
Author(s):  
M. De Hert ◽  
M. Dobbelaere ◽  
E.M. Sheridan ◽  
D. Cohen ◽  
C.U. Correll

AbstractSecond-generation antipsychotics (SGA) are being used more often than ever before in children and adolescents with psychotic and a wide range of non-psychotic disorders. Several SGA have received regulatory approval for some paediatric indications in various countries, but off-label use is still frequent. The aim of this paper was to perform a systematic review and critically evaluate the literature on cardiometabolic and endocrine side-effects of SGA in children and adolescents through a Medline/Pubmed/Google Scholar search of randomized, placebo controlled trials of antipsychotics in children and adolescents (<18 years old) until February 2010. In total, 31 randomized, controlled studies including 3595 paediatric patients were identified. A review of these data confirmed that SGA are associated with relevant cardiometabolic and endocrine side-effects, and that children and adolescents have a high liability to experience antipsychotic induced hyperprolactinaemia, weight gain and associated metabolic disturbances. Only weight change data were sufficiently reported to conduct a formal meta-analysis. In 24 trials of 3048 paediatric patients with varying ages and diagnoses, ziprasidone was associated with the lowest weight gain (−0.04 kg, 95% confidence interval [CI]: −0.38 to +0.30), followed by aripiprazole (0.79 kg, 95% CI: 0.54 to 1.04], quetiapine (1.43 kg, 95% CI: 1.17 to 1.69) and risperidone (1.76 kg, 95% CI: 1.27 to 2.25) were intermediate, and olanzapine was associated with weight gain the most (3.45 kg, 95% CI: 2.93 to 3.97). Significant weight gain appeared to be more prevalent in patients with autistic disorder who were also younger and likely less exposed to antipsychotics previously. These data clearly suggest that close screening and monitoring of metabolic side effects is warranted and that the least cardiometabolically problematic agents should be used first whenever possible. A good collaboration between child- and adolescent psychiatrists, general practitioners and paediatricians is essential to maximize overall outcomes and to reduce the likelihood of premature cardiovascular morbidity and mortality.


2006 ◽  
Vol 28 (4) ◽  
pp. 301-304 ◽  
Author(s):  
Carmen Lúcia Leitão-Azevedo ◽  
Lísia Rejane Guimarães ◽  
Martha Guerra Belmonte de Abreu ◽  
Clarissa Severino Gama ◽  
Maria Inês Lobato ◽  
...  

OBJECTIVE: First and second generation antipsychotics are associated with metabolic disturbances. A cross-sectional study was designed to follow outpatients at the Schizophrenia and Dementia Program at a major teaching hospital in Porto Alegre, Brazil (Hospital de Clínicas de Porto Alegre) in order to verify whether second generation antipsychotics were associated with higher glucose and lipid levels regardless of age and gender. METHOD: Four metabolic parameters (cholesterol and fractions, glucose and triglycerides) and anthropometric measures were obtained from 124 consecutive adult outpatients diagnosed with schizophrenia by DSM-IV and ICD-10 with the Operational Criteria Checklist for Psychotic Disorders system using the same antipsychotic drug for at least 9 weeks. RESULTS: Most patients had elevated BMI (76.6%) and dyslipidemia (84.7%). Clozapine users had lower HDL levels compared to first generation antipsychotics users. Both groups had elevated body mass index (p = 0.033; OR = 3.3; 95%CI = 1.1-9.8) and second generation antipsychotics (p = 0.021; OR = 3.5; 95%CI = 1.1-11.2) showed significant effect, adjusted for age and gender in the logistic regression for dyslipidemia, and significant age effect for hyperglycemia (p = 0.030; OR = 1.1; 95%CI = 1.0-1.1). DISCUSSION: There was statistically significant association between the use of second generation antipsychotics and dyslipidemia. It raises the issue of increased vulnerability of second generation antipsychotics-treated patients, regardless of age, as well as the need for assertive treatment for overweight and dyslipidemia in schizophrenia in order to reduce the risk of diabetes and cardiovascular disease.


Sign in / Sign up

Export Citation Format

Share Document