Psychosis Associated With Methylphenidate in Children and Adolescents

Caen University Hospital

Status: Completed

Conditions: Psychosis

Treatments: Drug: Intake of Methylphenidate

Study type: Observational

Funder types: Other

Identifiers

NCT06518330

Caen_MPH_2024

Details and patient eligibility

About

perform a study in VigiBase® to assess if methylphenidate was associated with an over-reporting of psychosis including hallucinations in children and adolescents and to characterize those psychosis.

Enrollment: 46,233 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Case reported in the World Health Organization (WHO) database of individual safety case reports until 16/02/2024 in children and adolescents treated with drugs with an indication in ADHD.

Adverse events reported were including a list of MedDRA Preferred Terms related to psychosis

Exclusion criteria

Chronology not compatible between the drug and the toxicity

Trial design

46,233 participants in 1 patient group

Patients presenting a possible drug-induced adverse effects

Description:

Drug: search for methylphenidate intake

Treatment:

Drug: Intake of Methylphenidate