Recruiting

Metabolic Adverse Events

Sponsor:

St. Justine's Hospital

Code:

NCT04395326

Conditions

Adverse Drug Event

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04395326

Start date

Jan 1, 2017

Status verified date

Apr, 2020

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Participant's demographic informations [ Time Frame: At baseline (inclusion) ]
  • Participant's clinical informations [ Time Frame: At baseline (inclusion) ]
  • Family metabolic informations [ Time Frame: At baseline (inclusion) ]
  • Evaluation of Adherence to second generation antipsychotic treatment [ Time Frame: At baseline (inclusion) ]
  • Evaluation of Adherence to second generation antipsychotic treatment [ Time Frame: At 1 month of follow-up ]
  • Evaluation of Adherence to second generation antipsychotic treatment [ Time Frame: At 2 months of follow-up ]
  • Evaluation of Adherence to second generation antipsychotic treatment [ Time Frame: At 3 months of follow-up ]
  • Evaluation of Adherence to second generation antipsychotic treatment [ Time Frame: At 6 months of follow-up ]
  • Evaluation of Adherence to second generation antipsychotic treatment [ Time Frame: At 9 months of follow-up ]
  • Evaluation of Adherence to second generation antipsychotic treatment [ Time Frame: At 12 months of follow-up ]
  • Evaluation of Adherence to second generation antipsychotic treatment [ Time Frame: At 24 months of follow-up ]
  • Assessment of change of Body Mass Index (BMI) at different times of the study [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At baseline, at 3, 6, 12 and 24 months of follow-up ]
  • Assessment of change of prolactin level at different times of the study [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At baseline, at 1, 3, 6, 12 and 24 months of follow-up ]

Central Contacts and Locations

Central contacts

Leila Ben Amor, MD, MSc

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

Drigissa Ilies, MD, MSc

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

Locations

Ben Amor Leila

Recruiting

Montréal, Quebec, Canada, H3T 1C5

Contacts

Leila Ben Amor, MD, MSc

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

Principal Investigator:

Leila Ben Amor, MD, MSc

More Information

Sponsor

St. Justine's Hospital

Last update posted

May 20, 2020

Last verified

Apr, 2020

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2020-05-20.