Attention Deficit Disorder With Hyperactivity
Conditions
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.
Interventions
DRUGMPH (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.
DRUGMPH (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.
DRUGAtomoxetine (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.
DRUGGuanfacine (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.
Sponsors
Janssen Research & Development, LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Stratified on Age, Sex, and Medication | Up to 5.8 years | 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. |
| Percentage of the Specialty of the Department of the First Prescriber who Prescribe MPH (Concerta), MPH (Ritalin), ATO, or GFC | Up to 5.8 years | 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. |
| Percentage of Participants whose First Prescription for MPH (Concerta), MPH (Ritalin), ATO, or GFC was Associated with an On-label Diagnosis | Up to 5.8 years | 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. |
| Percentage of Participants who Received More than Maximum Recommended Dose of MPH (Concerta), MPH (Ritalin), Methylphenidate (Concerta and Ritalin), ATO, or GFC | Up to 5.8 years | 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. |
| Percentage of Participants not Meeting Age Criteria at the Time of Receiving Medication | Up to 5.8 years | 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. |
| Percentage of Participants not Meeting Medication Criteria at the Time of Receiving Medication | Up to 5.8 years | 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. |
| Percentage of Participants whose Prescriptions were Consistent with all Aspects of the Label that was Current at the Time of the Prescription | 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 will be reported. The data will be taken from JMDC database for analysis. |
| Percentage of Participants with Shopping Behavior as a Marker of Misuse of Medications | Up to 5.8 years | 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. |
| Time Trends in Percentage of Participants Compliant with all Label Requirements | Up to 5.8 years | 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. |
Countries
United States
Outcome results
None listed