Psychosis Associated With Methylphenidate in Children and Adolescents

Completed

• Conditions: Psychosis
• Interventions: Drug: Intake of Methylphenidate

• Registration Number: NCT06518330
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1967-01-01
• Primary Completion: 2024-02-16
• Study Completion: 2024-02-16
• Status Verified: 2024-07
• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-18
• Last Update Submitted: 2024-07-18
• Study First Posted: 2024-07-24
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46233

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients presenting a possible drug-induced adverse effects	Intake of Methylphenidate	Drug: search for methylphenidate intake

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Caen University Hospital, Department of Pharmacology; 🇫🇷 Caen, France