Clinical trial NCT04113551: A Study of Label Compliance for Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan
Official title: Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan: A Retrospective Cohort Study of Label Compliance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-10-02
Enrollment: 17418
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Stratified on Age, Sex, and Medication
timeFrame: Up to 5.8 years
measure: Percentage of the Specialty of the Department of the First Prescriber who Prescribe MPH (Concerta), MPH (Ritalin), ATO, or GFC
timeFrame: Up to 5.8 years
measure: Percentage of Participants whose First Prescription for MPH (Concerta), MPH (Ritalin), ATO, or GFC was Associated with an On-label Diagnosis
timeFrame: Up to 5.8 years
measure: Percentage of Participants who Received More than Maximum Recommended Dose of MPH (Concerta), MPH (Ritalin), Methylphenidate (Concerta and Ritalin), ATO, or GFC
timeFrame: Up to 5.8 years
measure: Percentage of Participants not Meeting Age Criteria at the Time of Receiving Medication
timeFrame: Up to 5.8 years
measure: Percentage of Participants not Meeting Medication Criteria at the Time of Receiving Medication
timeFrame: Up to 5.8 years
measure: Percentage of Participants whose Prescriptions were Consistent with all Aspects of the Label that was Current at the Time of the Prescription
timeFrame: Up to 5.8 years
measure: Percentage of Participants with Shopping Behavior as a Marker of Misuse of Medications
timeFrame: Up to 5.8 years
measure: Time Trends in Percentage of Participants Compliant with all Label Requirements
timeFrame: Up to 5.8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Titusville
country: United States
facility: Janssen Investigative Site
state: New Jersey
Study officials:
affiliation: Janssen Research and Development LLC
name: Janssen Research and Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.