UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049401 |
|---|---|
| Receipt number | R000056252 |
| Scientific Title | A study describing the prevalence of non-psychiatric disorders in adult ADHD patients and conducting comparison with a control population: a cross-sectional study using the Japanese health insurance claims database |
| Date of disclosure of the study information | 2022/11/02 |
| Last modified on | 2023/11/16 09:39:53 |
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Basic information
Public title
A cross-sectional study investigating non-psychiatric comorbidities in adults with ADHD using the Japanese health insurance claims database
Acronym
A cross-sectional study investigating non-psychiatric comorbidities in Japanese adults with ADHD
Scientific Title
A study describing the prevalence of non-psychiatric disorders in adult ADHD patients and conducting comparison with a control population: a cross-sectional study using the Japanese health insurance claims database
Scientific Title:Acronym
A study describing the prevalence of non-psychiatric disorders in Japanese adult ADHD patients and conducting comparison with a control population
Region
| Japan |
Condition
Condition
Attention deficit / hyperactivity disorder (ADHD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the prevalence of non-psychiatric disorders in the adult ADHD patient population in Japan and to calculate the odds ratios of these disorders to the control population.
Basic objectives2
Others
Basic objectives -Others
Disease characteristics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence and odds ratios for type 2 diabetes mellitus, diabetic complications, hypertension, cardiovascular disease, dyslipidemia, gout/hyperuricemia, chronic obstructive pulmonary disease (COPD), nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH), atopic dermatitis, injury, upper respiratory infection, and low back pain
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 18 years or older at the end of October 2020.
2) The observation start date is before October 2020.
3) The observation end date is September 2021 or after.
Key exclusion criteria
No criteria
Target sample size
1200000
Research contact person
Name of lead principal investigator
| 1st name | Shinpei |
| Middle name | |
| Last name | Iwata |
Organization
Shionogi Pharmacovigilance Center Co., Ltd.
Division name
PMS & Pharmacoepidemiology
Zip code
541-0045
Address
4-7-6, Doshomachi, Chuo-ku, Osaka
TEL
070-7812-6559
shinpei.iwata@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Ishimoto |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs Department
Zip code
541-0045
Address
1-8, Doshomachi 3-Chome, Chuo-ku, Osaka
TEL
090-6916-8097
Homepage URL
yoshikazu.ishimoto@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Takeda Pharmaceutical Company Limited.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NO
Management information
Registered date
| 2022 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056252
