Psychosis Associated With Methylphenidate in Children and Adolescents

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06518330

Enrollment

46233

Registered

2024-07-24

Start date

1967-01-01

Completion date

2024-02-16

Last updated

2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis

Brief 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.

Interventions

DRUGIntake of Methylphenidate

Intake of Methylphenidate

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame
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.	from the 01/01/1967 to the 16/02/2024

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026