Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Case-control
Other

Non-interventional study design, other

Observational open-label pharmacovigilance study
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

METHYLPHENIDATE HYDROCHLORIDE

Medical condition to be studied

Attention deficit hyperactivity disorder
Population studied

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)

Estimated number of subjects

1600
Study design details

Main study objective

To establish three prospective cohorts of children and adolescents and to conduct a 24-month prospective open-label naturalistic observational cohort pharmacovigilance study to provide data required to answer several specific scientific questions about prevalence, clinical significance, and development for four specific classes of potential long-term adverse effects of methylphenidate use.

Outcomes

The primary outcome is the height velocity standard deviation scores (SDS) which is defined as: (Child’s height velocity - mean height velocity for sex & age) / (Standard Deviation of height velocity for sex & age). Secondary outcome parameters refer to growth, cardiovascular system, psychiatric and neurological measurements.

Data analysis plan

Characteristics of subjects included in the study will be described using the “5 number statistics” for quanitative variables and percentages for categorical variables. Traditional trivariate/bivariate comparisons will be done to compare the groups (ANOVA, chi-square tests and non-parametric tests, according to their conditions of validity).Incidence rates of side effects will be estimated in each of the 3 groups, but not compared statistically. The association with all primary and secondary endpoints will be statistically tested with all potential covariates of interest using traditional procedures (correlations, ANOVA, chi-square tests or non-parametric tests, according to their conditions of validity).The child’s height velocity will be estimated from all available data using simple linear regression of height with time.