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Completed

NCT Number: NCT04113551

A Study of Label Compliance for Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Janssen Investigative Site

Titusville, New Jersey, 08560, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MPH (Concerta)

Drug

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)

Drug

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)

Drug

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)

Drug

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.

Primary outcomes

  1. Percentage of Participants Stratified on Age, Sex, and Medication

    Time frame: 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.

  2. Percentage of the Specialty of the Department of the First Prescriber who Prescribe MPH (Concerta), MPH (Ritalin), ATO, or GFC

    Time frame: 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.

  3. Percentage of Participants whose First Prescription for MPH (Concerta), MPH (Ritalin), ATO, or GFC was Associated with an On-label Diagnosis

    Time frame: 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.

  4. Percentage of Participants who Received More than Maximum Recommended Dose of MPH (Concerta), MPH (Ritalin), Methylphenidate (Concerta and Ritalin), ATO, or GFC

    Time frame: 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.

  5. Percentage of Participants not Meeting Age Criteria at the Time of Receiving Medication

    Time frame: 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.

  6. Percentage of Participants not Meeting Medication Criteria at the Time of Receiving Medication

    Time frame: 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.

  7. Percentage of Participants whose Prescriptions were Consistent with all Aspects of the Label that was Current at the Time of the Prescription

    Time frame: 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.

  8. Percentage of Participants with Shopping Behavior as a Marker of Misuse of Medications

    Time frame: 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.

  9. Time Trends in Percentage of Participants Compliant with all Label Requirements

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan: A Retrospective Cohort Study of Label Compliance

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2019
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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