A Study of Label Compliance for Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan
NCT ID: NCT04113551
Last Updated: 2025-04-27
Study Results
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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COMPLETED
17418 participants
OBSERVATIONAL
2019-10-01
2020-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Have received, between 1 January, 2013 and 30 September, 2018, a prescription for Concerta, Ritalin, Atomoxetine (ATO) or Guanfacine (GFC)
Exclusion Criteria
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research and Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research and Development LLC
Locations
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Janssen Investigative Site
Titusville, New Jersey, United States
Countries
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References
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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.
Other Identifiers
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PCSESP001604
Identifier Type: OTHER
Identifier Source: secondary_id
CR108692
Identifier Type: -
Identifier Source: org_study_id
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