A Study of Label Compliance for Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan: A Retrospective Cohort Study of Label Compliance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04113551
• Other study ID #: CR108692
• Secondary ID: PCSESP001604
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: January 10, 2020

Study information

• Verified date: January 2020
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to document the extent of on-label and off-label use of Methylphenidate (MPH) (Concerta), MPH (Ritalin), Atomoxetine (ATO), and Guanfacine (GFC) in Japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17418
• Est. completion date: January 10, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participants have been in the database for greater than or equal to (>=) 30 days

• Have received, between 1 January, 2013 and 30 September, 2018, a prescription for Concerta, Ritalin, Atomoxetine (ATO) or Guanfacine (GFC)

Exclusion Criteria:

• Participants who received an unspecified Methylphenidate (MPH) formulation

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• MPH (Concerta)
MPH (Concerta) is approved for the indications of ADHD and Narcolepsy in Japan. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from Japan medical data center (JDMC) database.
• MPH (Ritalin)
MPH (Ritalin) is approved for the indication of ADHD in Japan. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from JDMC database.
• Atomoxetine (ATO)
Atomoxetine (ATO) is approved for the indication of ADHD in Japan. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from JDMC database.
• Guanfacine (GFC)
Guanfacine (GFC) is approved for the indication of ADHD in Japan. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from JDMC database.

Locations

Country	Name	City	State
United States	Janssen Investigative Site	Titusville	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Stratified on Age, Sex, and Medication	The percentage of participants stratified on age, sex, and medication (Methylphenidate [MPH] [Concerta], MPH [Ritalin], Atomoxetine [ATO], Guanfacine [GFC]) will be reported. The data will be taken from Japan Medical Data Center (JMDC) database for analysis.	Up to 5.8 years
Primary	Percentage of the Specialty of the Department of the First Prescriber who Prescribe MPH (Concerta), MPH (Ritalin), ATO, or GFC	The percentage of specialty of the department of the first prescriber for each first dispensing of each study medication will be reported. The data will be taken from JMDC database for analysis.	Up to 5.8 years
Primary	Percentage of Participants whose First Prescription for MPH (Concerta), MPH (Ritalin), ATO, or GFC was Associated with an On-label Diagnosis	The percentage of participants whose first prescription for MPH (Concerta), MPH (Ritalin), ATO, or GFC was associated with an on-label diagnosis, that is, a diagnosis of Attention Deficit Disorder with Hyperactivity (ADHD) for MPH (Concerta), ATO or GFC; or a diagnosis of narcolepsy for MPH (Ritalin) will be reported. The data will be taken from JMDC database for analysis.	Up to 5.8 years
Primary	Percentage of Participants who Received More than Maximum Recommended Dose of MPH (Concerta), MPH (Ritalin), Methylphenidate (Concerta and Ritalin), ATO, or GFC	The percentage of participants who received more than the maximum recommended dose of MPH (Concerta), MPH (Ritalin), Methylphenidate (Concerta and Ritalin), ATO, or GFC will be reported. The data will be taken from JMDC database for analysis.	Up to 5.8 years
Primary	Percentage of Participants not Meeting Age Criteria at the Time of Receiving Medication	Percentage of participants who at the time of receiving the medication were outside the approved age range will be reported. The data will be taken from JMDC database for analysis.	Up to 5.8 years
Primary	Percentage of Participants not Meeting Medication Criteria at the Time of Receiving Medication	Percentage of participants who at the time of receiving the medication had other contraindications will be reported. The data will be taken from JMDC database for analysis.	Up to 5.8 years
Primary	Percentage of Participants whose Prescriptions were Consistent with all Aspects of the Label that was Current at the Time of the Prescription	Percentage of participants whose prescriptions were consistent with all aspects of the label that was current at the time of the prescription will be reported. The data will be taken from JMDC database for analysis.	Up to 5.8 years
Primary	Percentage of Participants with Shopping Behavior as a Marker of Misuse of Medications	Percentage of participants whose use pattern of MPH (Concerta), MPH (Ritalin), MPH (Concerta and Ritalin) or ATO included prescriptions from three or more departments within any 18-month period will be reported. This describes "shopping behavior", which is a marker for misuse or abuse of medications. The data will be taken from JMDC database for analysis.	Up to 5.8 years
Primary	Time Trends in Percentage of Participants Compliant with all Label Requirements	The time trends in the percentage of participants whose prescriptions complied with all requirements of the label for MPH (Concerta), MPH (Ritalin), MPH (Concerta and Ritalin), ATO, and GFC will be reported. The data will be taken from JMDC database for analysis.	Up to 5.8 years