A Study of Label Compliance for Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan
Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan: A Retrospective Cohort Study of Label Compliance
2 other identifiers
observational
17,418
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedFirst Posted
Study publicly available on registry
October 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2020
CompletedApril 27, 2025
April 1, 2025
3 months
October 1, 2019
April 25, 2025
Conditions
Outcome Measures
Primary Outcomes (9)
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
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
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
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
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
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
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
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
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
Study Arms (14)
Cohort T1: Methylphenidate (MPH) (Concerta)
Analysis of data will be performed for participants who have had first exposure of MPH (Concerta) and who were never exposed to MPH (Ritalin) between 1 January 2013 and 30 September 2018 that also has continuous observation of at least 30 days prior to exposure.
Cohort T2: MPH (Ritalin)
Analysis of data will be performed for participants who have had first exposure of MPH (Ritalin) and who were never exposed to MPH (Concerta) between 1 January 2013 and 30 September 2018 that also has continuous observation of at least 30 days prior to exposure.
Cohort T3: MPH (Concerta and Ritalin)
Analysis of data will be performed for participants who have had exposure to Concerta and Ritalin during the time in the cohort between 1 January 2013 and 30 September 2018 and has continuous observation of at least 30 days prior to the exposures.
Cohort T4: Atomoxetine (ATO)
Analysis of data will be performed for participants who have had first exposure of ATO between 1 January 2013 and 30 September 2018 that also has continuous observation of at least 30 days prior to exposure.
Cohort T5: Guanfacine (GFC)
Analysis of data will be performed for participants who have had first exposure of GFC between 1 January 2013 and 30 September 2018 that also has continuous observation of at least 30 days prior to exposure.
Cohort T6: MPH (Concerta and Ritalin), ATO, or GFC
Analysis of data will be performed for participants who had have MPH (Concerta or Ritalin), ATO, or GFC first exposure between 1 January 2013 and 30 September 2018 that also has continuous observation of at least 30 days prior to exposure. These are all exposures to any study drug(s) among the participants with an exposure to at least one of the study drugs.
Cohort T7: MPH (Concerta or Ritalin)
Analysis of data will be performed for participants who had have MPH (Concerta or Ritalin) first exposure between 1 January 2013 and 30 September 2018 that also has continuous observation of at least 30 days prior. These are the first exposure to any MPH among the participants with who had some exposure to MPH.
Cohort T8: MPH (Concerta) All Exposures
Analysis of data will be performed for participants who have had all exposures of MPH (Concerta) and were never exposed to MPH (Ritalin) between 1 January 2013 and 30 September 2018 that also has continuous observation of at least 30 days prior to exposure.
Cohort T9: MPH (Ritalin) All Exposures
Analysis of data will be performed for participants who have had all exposures of MPH (Ritalin) and were never exposed to MPH (Concerta) between 1 January 2013 and 30 September 2018 that also has continuous observation of at least 30 days prior to exposure.
Cohort T10: ATO All Exposures
Analysis of data will be performed for participants who have had all exposures of ATO between 1 January 2013 and 30 September 2018 that also has continuous observation of at least 30 days prior to exposure.
Cohort T11: GFC All Exposures
Analysis of data will be performed for participants who have had all exposures of GFC between 1 January 2013 and 30 September 2018 that also has continuous observation of at least 30 days prior to exposure.
Cohort T12:MPH(Concerta and Ritalin),ATO,orGFC All Exposures
Analysis of data will be performed for participants who have had all exposures of MPH (Concerta or Ritalin), ATO, or GFC between 1 January 2013 and 30 September 2018 that also has continuous observation of at least 30 days prior to exposure. These are all exposures to any study drug(s) among the participants with an exposure to at least one of the study drugs.
Cohort T13: MPH (Concerta or Ritalin) All Exposures
Analysis of data will be performed for participants who have had all exposures of MPH (Concerta or Ritalin) between 1 January 2013 and 30 September 2018 that also has continuous observation of at least 30 days prior to exposure. These are all exposures to any MPH (Concerta or Ritalin) among the participants with an exposure to MPH (Concerta or Ritalin).
Cohort T14: MPH (Concerta and Ritalin) All Exposures
Analysis of data will be performed for participants who have had all exposures of MPH (Concerta and Ritalin) between 1 January 2013 and 30 September 2018 that also has continuous observation of at least 30 days prior to exposure. These are all exposures to any MPH (Concerta or Ritalin) among the participants with an exposure to MPH (Concerta) during the study period and to an exposure to MPH (Ritalin) during the study period.
Interventions
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) 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) 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) 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.
Eligibility Criteria
The study population will comprise of population (participants with attention deficit/hyperactivity disorder \[ADHD\]) described in the Japan Medical Data Center (JMDC) database which has data available through 1 January 2005 to 30 September 2018.
You may qualify if:
- 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)
You may not qualify if:
- \- Participants who received an unspecified Methylphenidate (MPH) formulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Janssen Investigative Site
Titusville, New Jersey, 08560, United States
Related Publications (1)
Fife D, Voss EA, Hardin J, Rofael H, Solomon ID, Ryan PB, Stang P. Medications for attention-deficit/hyperactivity disorder in Japan: A retrospective cohort study of label compliance. Neuropsychopharmacol Rep. 2021 Sep;41(3):385-392. doi: 10.1002/npr2.12191. Epub 2021 Jun 28.
PMID: 34180161DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research and Development, LLC Clinical Trial
Janssen Research and Development LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2019
First Posted
October 2, 2019
Study Start
October 1, 2019
Primary Completion
January 10, 2020
Study Completion
January 10, 2020
Last Updated
April 27, 2025
Record last verified: 2025-04