A Study of Label Compliance for Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan
Status
Completed
Conditions
Attention Deficit Disorder With Hyperactivity
Treatments
Drug: Guanfacine (GFC)
Drug: Atomoxetine (ATO)
Drug: MPH (Concerta)
Drug: MPH (Ritalin)
Study type
Observational
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
17,418 patients
Sex
All
Volunteers
No Healthy Volunteers
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
Trial design
17,418 participants in 14 patient groups
Cohort T1: Methylphenidate (MPH) (Concerta)
Description:
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.
Treatment:
Drug: MPH (Concerta)
Cohort T2: MPH (Ritalin)
Description:
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.
Treatment:
Drug: MPH (Ritalin)
Cohort T3: MPH (Concerta and Ritalin)
Description:
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.
Treatment:
Drug: MPH (Ritalin)
Drug: MPH (Concerta)
Cohort T4: Atomoxetine (ATO)
Description:
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.
Treatment:
Drug: Atomoxetine (ATO)
Cohort T5: Guanfacine (GFC)
Description:
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.
Treatment:
Drug: Guanfacine (GFC)
Cohort T6: MPH (Concerta and Ritalin), ATO, or GFC
Description:
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.
Treatment:
Drug: MPH (Ritalin)
Drug: MPH (Concerta)
Drug: Atomoxetine (ATO)
Drug: Guanfacine (GFC)
Cohort T7: MPH (Concerta or Ritalin)
Description:
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.
Treatment:
Drug: MPH (Ritalin)
Drug: MPH (Concerta)
Cohort T8: MPH (Concerta) All Exposures
Description:
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.
Treatment:
Drug: MPH (Concerta)
Cohort T9: MPH (Ritalin) All Exposures
Description:
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.
Treatment:
Drug: MPH (Ritalin)
Cohort T10: ATO All Exposures
Description:
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.
Treatment:
Drug: Atomoxetine (ATO)
Cohort T11: GFC All Exposures
Description:
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.
Treatment:
Drug: Guanfacine (GFC)
Cohort T12:MPH(Concerta and Ritalin),ATO,orGFC All Exposures
Description:
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.
Treatment:
Drug: MPH (Ritalin)
Drug: MPH (Concerta)
Drug: Atomoxetine (ATO)
Drug: Guanfacine (GFC)
Cohort T13: MPH (Concerta or Ritalin) All Exposures
Description:
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).
Treatment:
Drug: MPH (Ritalin)
Drug: MPH (Concerta)
Cohort T14: MPH (Concerta and Ritalin) All Exposures
Description:
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.
Treatment:
Drug: MPH (Ritalin)
Drug: MPH (Concerta)
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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