UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000048319
Receipt number	R000055067
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
Date of disclosure of the study information	2022/07/17
Last modified on	2022/07/08 11:23:00

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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

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Neurodevelopmental Disorders (Attention Deficit/Hyperactivity Disorder: ADHD/Autistic Spectrum Disorder: ASD)

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

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

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

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 or person

Institute

International University of Health and Welfare

Institute

Department

Personal name

Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055067