Psychosis Associated With Methylphenidate in Children and Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46233 participants

Study Classification

OBSERVATIONAL

Study Start Date

1967-01-01

Study Completion Date

2024-02-16

Brief Summary

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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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Detailed Description

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Conditions

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Psychosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients presenting a possible drug-induced adverse effects

Drug: search for methylphenidate intake

Intake of Methylphenidate

Intervention Type DRUG

Intake of Methylphenidate

Interventions

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Intake of Methylphenidate

Intervention Type DRUG

Eligibility Criteria

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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