Attention Deficit Disorder With HyperactivityNCT04113551
A Study of Label Compliance for Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan
An observational study of Attention Deficit Disorder With Hyperactivity, run by Janssen Research & Development, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- MPH (Concerta), MPH (Ritalin) and Atomoxetine (ATO)
- How many people
- 17,418 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 10 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Participants who received an unspecified Methylphenidate (MPH) formulation
Trial locations and contacts
1 site in 1 country.
United States1 site
Janssen Investigative Site
Titusville, New Jersey, 08560
About this study
Official title: Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan: A Retrospective Cohort Study of Label Compliance
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.
- Being tested
- MPH (Concerta), MPH (Ritalin), Atomoxetine (ATO), Guanfacine (GFC)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: MPH (Concerta) | |
| 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. Receives: Drug: MPH (Ritalin) | |
| 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. Receives: Drug: MPH (Concerta); Drug: MPH (Ritalin) | |
| 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. Receives: Drug: Atomoxetine (ATO) | |
| 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. Receives: Drug: Guanfacine (GFC) | |
| 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. Receives: Drug: MPH (Concerta); Drug: MPH (Ritalin); Drug: Atomoxetine (ATO); Drug: Guanfacine (GFC) | |
| 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. Receives: Drug: MPH (Concerta); Drug: MPH (Ritalin) | |
| 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. Receives: Drug: MPH (Concerta) | |
| 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. Receives: Drug: MPH (Ritalin) | |
| 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. Receives: Drug: Atomoxetine (ATO) | |
| 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. Receives: Drug: Guanfacine (GFC) | |
| 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. Receives: Drug: MPH (Concerta); Drug: MPH (Ritalin); Drug: Atomoxetine (ATO); Drug: Guanfacine (GFC) | |
| 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). Receives: Drug: MPH (Concerta); Drug: MPH (Ritalin) | |
| 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. Receives: Drug: MPH (Concerta); Drug: MPH (Ritalin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Stratified on Age, Sex, and Medication
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.
Measured: Up to 5.8 years
Percentage of the Specialty of the Department of the First Prescriber who Prescribe MPH (Concerta), MPH (Ritalin), ATO, or GFC
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.
Measured: Up to 5.8 years
Percentage of Participants whose First Prescription for MPH (Concerta), MPH (Ritalin), ATO, or GFC was Associated with an On-label Diagnosis
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.
Measured: Up to 5.8 years
Percentage of Participants who Received More than Maximum Recommended Dose of MPH (Concerta), MPH (Ritalin), Methylphenidate (Concerta and Ritalin), ATO, or GFC
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.
Measured: Up to 5.8 years
Percentage of Participants not Meeting Age Criteria at the Time of Receiving Medication
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.
Measured: Up to 5.8 years
Percentage of Participants not Meeting Medication Criteria at the Time of Receiving Medication
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.
Measured: 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
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.
Measured: Up to 5.8 years
Percentage of Participants with Shopping Behavior as a Marker of Misuse of Medications
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.
Measured: Up to 5.8 years
Time Trends in Percentage of Participants Compliant with all Label Requirements
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.
Measured: Up to 5.8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Oct 2019
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 17,418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research and Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113551
- Sponsor's protocol ID
- CR108692
- Other IDs
- PCSESP001604
- Status last verified
- Apr 2025
- First submitted
- 1 Oct 2019
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 34180161
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan: A Retrospective Cohort Study of Label Compliance
- ClinicalTrials.gov ID
- NCT04113551
- Acronym / sponsor ID
- CR108692
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,418 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Cohort T1: Methylphenidate (MPH) (Concerta) | – | Drug: 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. |
| Cohort T2: MPH (Ritalin) | – | Drug: 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. |
| Cohort T3: MPH (Concerta and Ritalin) | – | Drug: MPH (Concerta), Drug: MPH (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. |
| Cohort T4: Atomoxetine (ATO) | – | Drug: 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. |
| Cohort T5: Guanfacine (GFC) | – | Drug: 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. |
| Cohort T6: MPH (Concerta and Ritalin), ATO, or GFC | – | Drug: MPH (Concerta), Drug: MPH (Ritalin), Drug: Atomoxetine (ATO), Drug: Guanfacine (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. |
| Cohort T7: MPH (Concerta or Ritalin) | – | Drug: MPH (Concerta), Drug: MPH (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. |
| Cohort T8: MPH (Concerta) All Exposures | – | Drug: MPH (Concerta)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. |
| Cohort T9: MPH (Ritalin) All Exposures | – | Drug: MPH (Ritalin)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. |
| Cohort T10: ATO All Exposures | – | Drug: Atomoxetine (ATO)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. |
| Cohort T11: GFC All Exposures | – | Drug: Guanfacine (GFC)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. |
| Cohort T12:MPH(Concerta and Ritalin),ATO,orGFC All Exposures | – | Drug: MPH (Concerta), Drug: MPH (Ritalin), Drug: Atomoxetine (ATO), Drug: Guanfacine (GFC)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. |
| Cohort T13: MPH (Concerta or Ritalin) All Exposures | – | Drug: MPH (Concerta), Drug: MPH (Ritalin)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). |
| Cohort T14: MPH (Concerta and Ritalin) All Exposures | – | Drug: MPH (Concerta), Drug: MPH (Ritalin)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Participants who received an unspecified Methylphenidate (MPH) formulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Cohort T12:MPH(Concerta and Ritalin),ATO,orGFC All Exposures, Cohort T13: MPH (Concerta or Ritalin) All Exposures, Cohort T14: MPH (Concerta and Ritalin) All Exposures, Cohort T1: Methylphenidate (MPH) (Concerta), Cohort T3: MPH (Concerta and Ritalin), Cohort T6: MPH (Concerta and Ritalin), ATO, or GFC, Cohort T7: MPH (Concerta or Ritalin), Cohort T8: MPH (Concerta) All Exposures |
| 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. | Drug | Cohort T12:MPH(Concerta and Ritalin),ATO,orGFC All Exposures, Cohort T13: MPH (Concerta or Ritalin) All Exposures, Cohort T14: MPH (Concerta and Ritalin) All Exposures, Cohort T2: MPH (Ritalin), Cohort T3: MPH (Concerta and Ritalin), Cohort T6: MPH (Concerta and Ritalin), ATO, or GFC, Cohort T7: MPH (Concerta or Ritalin), Cohort T9: MPH (Ritalin) All Exposures |
| 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. | Drug | Cohort T10: ATO All Exposures, Cohort T12:MPH(Concerta and Ritalin),ATO,orGFC All Exposures, Cohort T4: Atomoxetine (ATO), Cohort T6: MPH (Concerta and Ritalin), ATO, or GFC |
| 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. | Drug | Cohort T11: GFC All Exposures, Cohort T12:MPH(Concerta and Ritalin),ATO,orGFC All Exposures, Cohort T5: Guanfacine (GFC), Cohort T6: MPH (Concerta and Ritalin), ATO, or GFC |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Derived from this study: PubMed 34180161Fife 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research and Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder With Hyperactivity, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Stratified on Age, Sex, and Medication (time frame: Up to 5.8 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04113551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.