Psychosis Associated With Methylphenidate in Children and... | NCT06518330

Studies
Psychosis Associated With Methylphenidate in Children and Adolescents

NCT06518330

Sponsor

University Hospital, Caen

Status

Completed

Last Update Posted

Jul 24, 2024Actual

Enrollment

46,233Actual

Phase

Not provided

Conditions

Psychosis

Interventions

Intake of Methylphenidate

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 1967Actual

Primary Completion Date

Feb 16, 2024Actual

Completion Date

Feb 16, 2024Actual

First Submitted Date

Jul 18, 2024

First Submission Date that Met QC Criteria

Jul 18, 2024

First Posted Date

Jul 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2024

Last Update Posted Date

Jul 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46,233Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intake of Methylphenidate	Drug	Intake of Methylphenidate	Patients presenting a possible drug-induced adverse effects

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Patients with a possible drug-induced adverse effect

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Caen University Hospital, Department of Pharmacology		Caen			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011618	Psychotic Disorders

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided