NCT06518330Completed
Psychosis Associated With Methylphenidate in Children and Adolescents
Psychosis and Hallucinations in Methylphenidate-Treated Children: A Pharmacovigilance Study Using Vigibase
Source: ClinicalTrials.gov · Last updated 24 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 46233 (actual)
- First submitted
- 18 Jul 2024
- Start date
- 1 Jan 1967
- Primary completion date
- 16 Feb 2024
- Lead sponsor
- University Hospital, Caen
- Diseases
- Schizophrenia
- NCT number
- NCT06518330
What you commit to
- Study type: Observational
- Participants enrolled: 46233
- From 1 Jan 1967 to the primary completion date, 16 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronology not compatible between the drug and the toxicity
Who the study is looking for
- 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
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Caen University Hospital, Department of Pharmacology Coordinator of this site? Confirm its status | Caen | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.