UMIN-CTR Clinical Trial

Basic information
Public title	An Attempt to Understand the Actual Condition of Comorbidities in Adult Patients with Neurodevelopmental Disorders (Attention Deficit/Hyperactivity Disorder: ADHD/Autistic Spectrum Disorder: ASD) Using DPC Data
Acronym	An Attempt to Understand the Actual Condition of Comorbidities in Adult Patients with Neurodevelopmental Disorders (Attention Deficit/Hyperactivity Disorder: ADHD/Autistic Spectrum Disorder: ASD) Using DPC Data
Scientific Title	An Attempt to Understand the Actual Condition of Comorbidities in Adult Patients with Neurodevelopmental Disorders (Attention Deficit/Hyperactivity Disorder: ADHD/Autistic Spectrum Disorder: ASD) Using DPC Data
Scientific Title:Acronym	An Attempt to Understand the Actual Condition of Comorbidities in Adult Patients with Neurodevelopmental Disorders (Attention Deficit/Hyperactivity Disorder: ADHD/Autistic Spectrum Disorder: ASD) Using DPC Data
Region	Japan

Condition
Condition	Neurodevelopmental Disorders (Attention Deficit/Hyperactivity Disorder: ADHD/Autistic Spectrum Disorder: ASD)
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study will evaluate the actual status of comorbidities in adult patients with neurodevelopmental disorders such as attention-deficit/hyperactivity disorder (ADHD) and autistic spectrum disorder (ASD) using the DPC database, a big data set for medical care, and compare the results obtained with previous Japanese studies to determine to what extent the DPC data reflect the actual clinical status of neurodevelopmental disorders.
Basic objectives2	Others
Basic objectives -Others	In this study, we will utilize DPC data, which is Japanese big data, to understand the actual status of comorbidities in patients with developmental disabilities, and compare it with previous studies. By understanding the degree of discrepancy, we will examine whether the DPC data is a database that can withstand investigation of patients with neurodevelopmental disorders. It is easy to assume that patients with developmental disorders in adulthood tend to present with symptoms of comorbidities rather than with symptoms of developmental disorders themselves. Since such patients are likely to have severe developmental disorders, it is important to diagnose them without overlooking the developmental disorders underlying their comorbidities. Therefore, clarifying which comorbidities tend to be associated with developmental disorders in adult patients with developmental disorders is expected to help in the proper diagnosis of ASD/ADHD.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The objectives of the study are (1) To understand the actual status of comorbidities in ADHD patients using the DPC database (2) To understand the actual status of comorbidities in ASD patients using the DPC database. (3) To compare the results of the survey using the DPC database with previous studies in Japan, and to examine the validity of the survey of the actual conditions of neurodevelopmental disorders using the DPC database. These are the above three points. <Data Acquisition Method> Survey data: DPC data for the past five years will be provided by a third party from the DPC Data Research Group (Fushimi Group of the MHLW Science Research). Subjects will be cases at all DPC survey hospitals in Japan (approximately 1,600 facilities). Target facilities: Of the approximately 1,600 DPC hospitals, those that have agreed to provide data to the study group and have provided DPC survey data to the Diagnostic Group Classification Research Support Organization. Subjects: ADHD/ASD cases in adulthood (age 18 or older) from April 2016 to March 2020 included in the DPC survey data Data to be obtained: DPC survey data; Form 1, Form 3, Form 4, inpatient and outpatient EF and D files Extraction method: [ADHD/ASD [ADHD/ASD] is extracted from the following codes. (Disease name: ICD10 code) ADHD F90: Hyperactivity disorder (Attention deficit hyperactivity disorder: F900, Hyperactivity disorder: F901, Childhood behavioral disorder/hyperactivity disorder: F909) ASD F84.9: Pervasive developmental disorder, details unknown (Pervasive developmental disorder: F849, Autism spectrum disorder:F849)
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
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Dynamic allocation
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Blocking
Concealment

Intervention
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Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients diagnosed with ADHD/ASD Patients over 18 years old at the time of ADHD/ASD diagnosis
Key exclusion criteria	None
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Mutsuhiro Middle name Last name Nakao
Organization	International University of Health and Welfare
Division name	Graduate School of Medicine, Department of Public Health
Zip code	107-8402
Address	4-1-26 Akasaka, Minato-ku, Tokyo
TEL	03-5574-3900
Email	m-nakao@iuhw.ac.jp

Public contact
Name of contact person	1st name Takuma Middle name Last name Sotodate
Organization	International University of Health and Welfare
Division name	Graduate School of Medicine, Department of Public Health
Zip code	162-0811
Address	201 Grantebach Kagurazaka, 4-7 Suido-cho, Shinjuku-ku, Tokyo
TEL	090-9305-2543
Homepage URL
Email	takuma.sotodate@takeda.com

Sponsor
Institute	International University of Health and Welfare
Institute
Department

Funding Source
Organization	None
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Division
Category of Funding Organization	Other
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IRB Contact (For public release)
Organization	International University of Health and Welfare
Address	4-1-26 Akasaka, Minato-ku, Tokyo
Tel	03-5574-3900
Email	akasaka-nyushi@iuhw.ac.jp

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 07 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Progress
Recruitment status	Preinitiation
Date of protocol fixation	2022 Year 04 Month 28 Day
Date of IRB	2022 Year 06 Month 07 Day
Anticipated trial start date	2022 Year 08 Month 01 Day
Last follow-up date	2022 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Data will be extracted after August 1, 2022.

Management information
Registered date	2022 Year 07 Month 08 Day
Last modified on	2022 Year 07 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055067