CompletedNot Applicable

Psychosis Associated With Methylphenidate in Children and Adolescents

France46,233 participantsStarted 1967-01-01

Plain-language summary

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.

Who can participate

Age range5 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Correlation between methylphenidate and psychosis in children and adolescents using a disproportionality analysis in Individual Case Reports involving at least one liable drug with an indication in ADHD.

Timeframe: from the 01/01/1967 to the 16/02/2024

Trial details

NCT IDNCT06518330

SponsorUniversity Hospital, Caen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-16

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