Monitoring of Metabolic Adverse Events of Second Generation Antipsychotics in a Naive Pediatric Population

NCT04395326 | Unknown

• 1 other identifier: MP-21-2016-1201
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Second Generation Antipsychotics (SGAs) are widely used in the pediatric population. It is currently established that SGAs may induce undesirable metabolic adverse events (AEs) such as weight gain, metabolic changes in 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 in the pediatric population. 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 analysis: The MEMAS study (Monitoring des Effets Métaboliques des Antipsychotiques de Seconde Génération) design is a multicenter, prospective, longitudinal observational study with repeated measures of metabolic monitoring up to 24 months of follow-up. Two recruiting centers have been selected for patients under 18 years of age, previously naïve 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 at inclusion and during follow-up for anthropometric measures (AM), blood pressure (BP) and blood tests (BT) at baseline and 1, 2, 3, 6, 9, 12 and 24 months of follow-up. Ethics and dissemination: The study protocol was approved by the Centre Hospitalier Universitaire (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" (CIUSSS NIM) 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.

Conditions

Adverse Drug Event

Keywords

metabolic side effects; naïve pediatric population; second generation antipsychotics; predictive factors; monitoring

Outcome Measures

Primary Outcomes (24)

• Participant's demographic informations

  Sex, age, ethnic group, socioeconomic status will be collected

  At baseline (inclusion)

• Participant's clinical informations

  Several participant's clinical informations will be collected : recruitment center, inpatient or outpatient status, main diagnosis (DSM-5), comorbidities, second generation antipsychotic prescribed and its dosage, co-medication type and dosage. In order to create an equivalence between the doses of APs received, a conversion to an equivalent dose of chlorpromazine will be carried out according to published standards (Woods et al., 2003).

  At baseline (inclusion)

• Family metabolic informations

  Presence or not of obesity, dyslipidemia, diabetes and gestational diabetes, high blood pressure, cardiovascular disease in parents will be asked ; and reported weight (in kilograms) and height (in meters) of the parents will be collected (but not measured).

  At baseline (inclusion)

• Evaluation of Adherence to second generation antipsychotic treatment

  Compliance will be indirectly estimated by the nurse and/or the treating psychiatrist at each measurement time of the CAMESA calendar, according to a voluntary declaration by the participants. The date of renewal of the psychotropic medication will also be verified using the Quebec medical record database ("Dossier Santé Québec (DSQ)") and compared to the patient's declaration. The adherence will therefore be counted as the number of days of missed SGA dose per week or per month.

  At baseline (inclusion)

• Evaluation of Adherence to second generation antipsychotic treatment

  Compliance will be indirectly estimated by the nurse and/or the treating psychiatrist at each measurement time of the CAMESA calendar, according to a voluntary declaration by the participants. The date of renewal of the psychotropic medication will also be verified using the Quebec medical record database ("Dossier Santé Québec (DSQ)") and compared to the patient's declaration. The adherence will therefore be counted as the number of days of missed SGA dose per week or per month.

  At 1 month of follow-up

• Evaluation of Adherence to second generation antipsychotic treatment

  Compliance will be indirectly estimated by the nurse and/or the treating psychiatrist at each measurement time of the CAMESA calendar, according to a voluntary declaration by the participants. The date of renewal of the psychotropic medication will also be verified using the Quebec medical record database ("Dossier Santé Québec (DSQ)") and compared to the patient's declaration. The adherence will therefore be counted as the number of days of missed SGA dose per week or per month.

  At 2 months of follow-up

• Evaluation of Adherence to second generation antipsychotic treatment

  Compliance will be indirectly estimated by the nurse and/or the treating psychiatrist at each measurement time of the CAMESA calendar, according to a voluntary declaration by the participants. The date of renewal of the psychotropic medication will also be verified using the Quebec medical record database ("Dossier Santé Québec (DSQ)") and compared to the patient's declaration. The adherence will therefore be counted as the number of days of missed SGA dose per week or per month.

  At 3 months of follow-up

• Evaluation of Adherence to second generation antipsychotic treatment

  Compliance will be indirectly estimated by the nurse and/or the treating psychiatrist at each measurement time of the CAMESA calendar, according to a voluntary declaration by the participants. The date of renewal of the psychotropic medication will also be verified using the Quebec medical record database ("Dossier Santé Québec (DSQ)") and compared to the patient's declaration. The adherence will therefore be counted as the number of days of missed SGA dose per week or per month.

  At 6 months of follow-up

• Evaluation of Adherence to second generation antipsychotic treatment

  Compliance will be indirectly estimated by the nurse and/or the treating psychiatrist at each measurement time of the CAMESA calendar, according to a voluntary declaration by the participants. The date of renewal of the psychotropic medication will also be verified using the Quebec medical record database ("Dossier Santé Québec (DSQ)") and compared to the patient's declaration. The adherence will therefore be counted as the number of days of missed SGA dose per week or per month.

  At 9 months of follow-up

• Evaluation of Adherence to second generation antipsychotic treatment

  Compliance will be indirectly estimated by the nurse and/or the treating psychiatrist at each measurement time of the CAMESA calendar, according to a voluntary declaration by the participants. The date of renewal of the psychotropic medication will also be verified using the Quebec medical record database ("Dossier Santé Québec (DSQ)") and compared to the patient's declaration. The adherence will therefore be counted as the number of days of missed SGA dose per week or per month.

  At 12 months of follow-up

• Evaluation of Adherence to second generation antipsychotic treatment

  Compliance will be indirectly estimated by the nurse and/or the treating psychiatrist at each measurement time of the CAMESA calendar, according to a voluntary declaration by the participants. The date of renewal of the psychotropic medication will also be verified using the Quebec medical record database ("Dossier Santé Québec (DSQ)") and compared to the patient's declaration. The adherence will therefore be counted as the number of days of missed SGA dose per week or per month.

  At 24 months of follow-up

• Assessment of change of Body Mass Index (BMI) at different times of the study

  Assessment of weight and height will be taken using the same instruments and according to a standardized technique. Body Mass Index (BMI) will be calculated with the weight (kilograms) divided by the height squared (m2). Then, the BMI is standardized for sex and age according to the growth charts of the Centers for Disease Control (CDC) (Ogden et al., 2002) in order to obtain the BMI-z score. Significant weight gain is defined by a 0.5 increase in BMI-z score. Being overweight is defined by a BMI-z between the 85th and the 95th percentile. Obesity is defined by a BMI-z equal to or greater than the 95th percentile.

  At baseline, at 1, 2, 3, 6, 9, 12 and 24 months of follow-up

• Assessment of change of waist circumference at different times of the study

  Waist circumference (centimeters) will be taken using the same instruments and according to a standardized technique. The waist circumference percentiles will be calculated according to established Canadian standards for age and sex (Katzmarzyk et al., 2004).

  At baseline, at 1, 2, 3, 6, 9, 12 and 24 months of follow-up

• Assessment of change of Blood pressure at different times of the study

  Systolic and diastolic pressures will be assessed and considered abnormal when it is equal to or higher than the 90th percentile to follow pediatric standards (Cook et al. 2003; Weiss et al., 2004).

  At baseline, at 1, 2, 3, 6, 9, 12 and 24 months of follow-up

• Assessment of change of fasting lipids level at different times of the study

  The threshold values (mmol/L) for fasting lipids are those recommended by the National Cholesterol Education Program (NCEP, 1992), grouped into commonly used categories (Cook et al., 2003) : total cholesterol \> 5.15; LDL \>3.34; non-HDL cholesterol \>3.73; HDL \>1.04; triglycerides (0-9 years) \>1.12; triglycerides \>1.46 (10-19 years).

  At baseline, at 3, 6, 12 and 24 months of follow-up

• Assessment of change of fasting glucose level at different times of the study

  Laboratory testing includes fasting blood sugar. Diabetes will be defined according to the criteria (fasting glucose ≥ 0.7 mmol/L with confirmation by other test) established by the American Diabetes Association (ADA, 2004).

  At baseline, at 3, 6, 12 and 24 months of follow-up

• Assessment of change of fasting insulinemia level at different times of the study

  Laboratory testing includes fasting insulinemia level. Insulin resistance will be estimated with the Homeostasis Model Assessment Insulin - Resistance Index (HOMA-IR) = \[Insulin (µUI/ml) x glucose (mg/dl)/405\] (Matthews et al., 1985). The threshold value of 2.28 will define insulin resistance (Tresaco et al., 2005).

  At baseline, at 3, 6, 12 and 24 months of follow-up

• Assessment of change of prolactin level at different times of the study

  Laboratory testing includes prolactin level with normal range between 5 to 20 ng/mL.

  At baseline, at 3, 12 and 24 months of follow-up

• Assessment of change of thyroid stimulating hormone (TSH) level at different times of the study

  Laboratory testing includes thyroid stimulating hormone level with normal rate \< 10 milliunits per liter (mU/L).

  At baseline, at 6, 12 and 24 months of follow-up.

• Assessment of change of alanine aminotransferase (ALT) level at different times of the study

  Laboratory testing includes alanine aminotransferase level with normal range between 5 to 40 U/L.

  At baseline, at 6, 12 and 24 months of follow-up

• Assessment of change in responses to the physical activity MEMAS questionnaire at different times of the study

  This self-questionnaire using a compilation of different validated items obtained from the United States Youth Risk Behavior Surveillance System (Brener et al, 2013), from Patient-centered Assessment and Counseling for Exercise + Nutrition, a 2-item validated questionnaire for adolescent physical activity (Hardie Murphy et al, 2015; Prochaska et al, 2001) and also include questions on the perception of self-efficacy during exercise (Motl et al, 2000). Screen time questions collect the number of hours spent during weekdays/ends (Schmitz et al, 2004). Items about transportation to school were adapted from the questionnaire of the Canadian branch of the Health Behavior in School-aged Children (Currie et al, 2010; Gropp et al, 2013). Time spent outdoors outside of school hours is evaluated by the International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE)(LeBlanc et al, 2015; Katzmarzyk et al,2013), items are rated from 0 (strongly disagree) to 4 (very much agree).

  At baseline, at 1, 3, 6, 12 and 24 months of follow-up

• Assessment of change in responses to the sleep MEMAS questionnaire at different times of the study

  This part of the questionnaire compiles items on the duration (in number of hours) and quality of sleep (from " very good " =1 to " very bad " =4). Items were included since the literature seems to point out a link between lack of sleep and obesity (Chaput \& Tremblay, 2012; Chen et al., 2008; Fatima et al., 2015; Patel \& Hu, 2008).

  At baseline, at 1, 3, 6, 12 and 24 months of follow-up

• Assessment of change in responses to the eating habits MEMAS questionnaire at different times of the study

  Eating habits will be assessed using a Food Frequency Questionnaire from the Canadian branch of the Health Behavior in School-aged Children study (Currie et al., 2010; Vereecken \& Maes, 2003) and culturally adapted by the ISCOLE team. These items are rated from 1 (no day a week) to 6 (5 days a week). Additional items concerning snacks while watching television (Van den Bulck \& Van Mierlo, 2004), school meals (Johnson et al., 2014), meals from outside. These items are rated from 1 (no day a week) to 6 (5 days a week). Emotional hunger (Striegel-Moore et al., 1999) are also included. These items are rated from 1 (" never or almost never ") to 3 (" usually or always ").

  At baseline, at 1, 3, 6, 12 and 24 months of follow-up

• Assessment of change of Tanner scores at different times of the study

  Puberty status will be assessed using a questionnaire developed by Morris and Udry (1980) which includes illustrations of the five Tanner stages of pubertal development, accompanied by brief descriptions (stage 1 = no puberty, stade 2 = completed puberty).

  At baseline, at 1, 3, 6, 12 and 24 months of follow-up

Study Arms (1)

24 months follow-up

Single-group study Patients have been included for up to 4 weeks after the initiation of Second Generation Antipsychotic (SGA) treatment (baseline) Patients under 18 years of age, previously naïve of antipsychotics, starting an SGA or who started an SGA treatment for less than 4 weeks, followed longitudinally at one of the selected recruiting centers, regardless of the diagnosis that motivated the prescription. Comedications and combination of APs are allowed, as this is an observational study. The exclusion criteria are the following: participants diagnosed before or at the baseline with diabetes, dyslipidemia, high blood pressure, thyroid dysfunction, hepatic disease, a disorder that can lead to hyperprolactinemia or another disorder that may interfere with the development of the side effects studied in this research, participants taking a drug intended to treat one of the conditions mentioned above before starting the SGA treatment, and pregnancy.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric Population Followed in Mental Health Outpatient and Inpatient Clinical Settings treated by second generation antipsychotics for the first time.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Ciusss de L'Est de l'Île de Montréal: collaborator

Study Sites (1)

Ben Amor Leila

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

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MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Leila Ben Amor, MD, MSc

  Sainte Justine Hospital

  STUDY CHAIR

• Drigissa Ilies, MD, MSC

  Rivières des Praires Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leila Ben Amor, MD, MSc

CONTACT

(1) 514 345 4931; leila.ben.amor.hsj@ssss.gouv.qc.ca

Drigissa Ilies, MD, MSc

CONTACT

(1) 514 323 7260; drigissa-andrada.ilies.cnmtl@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 20, 2020
• Study Start: January 1, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 20, 2020

Record last verified: 2020-04

Locations

CA (1)