Psychosis Associated With Methylphenidate in Children and Adolescents

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.

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Key information

Conditions

Psychosis Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen University Hospital, Department of Pharmacology

Caen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intake of Methylphenidate

Drug

Intake of Methylphenidate

Primary outcomes

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.

Time frame: from the 01/01/1967 to the 16/02/2024

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

Psychosis and Hallucinations in Methylphenidate-Treated Children: A Pharmacovigilance Study Using Vigibase

Important dates

Study start: 1967
Primary completion: 2024
Study completion: 2024
First posted: Jul 24, 2024
Registry last updated: Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed