UMIN-CTR Clinical Trial

Basic information
Public title	Prevalence of autism spectrum disorder and attention-deficit hyperactivity disorder in adults with chronic pain in Japan
Acronym	epidemiological survey of ASD and ADHD with chronic pain in Japan
Scientific Title	Prevalence of autism spectrum disorder and attention-deficit hyperactivity disorder in adults with chronic pain in Japan
Scientific Title:Acronym	epidemiological survey of ASD and ADHD with chronic pain in Japan
Region	Japan

Condition
Condition	autism spectrum disorder, attention-deficit hyperactivity disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	investigation autism spectrum disorder and atention-deficit hyperactivity disorder in adult with chronic pain in Japan
Basic objectives2	Others
Basic objectives -Others	investigation of prevalence, location, duration and causes of chronic pan in ASD and ADHD in adult in Japan
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	prevalence of prevalence of autism spectrum disorder and attention-deficit hyperactivity disorder in adults with chronic 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with ASD and ADHD over 20 years old
Key exclusion criteria	dementia patients who cannot read and write Japanese
Target sample size	250

Research contact person
Name of lead principal investigator	1st name YOSUKE Middle name Last name TOMINAGA
Organization	Showa university Karasuyama hospital
Division name	Psychiatry
Zip code	157-8577
Address	6-11-11 Kitakarasuyama, Setagaya-ku, Tokyo
TEL	03-3300-5231
Email	ytomi@med.showa-u.ac.jp

Public contact
Name of contact person	1st name YOSUKE Middle name Last name TOMINAGA
Organization	Showa university Karasuyama hospital
Division name	Psychiatry
Zip code	157-8577
Address	6-11-11 Kitakarasuyama, Setagaya-ku, Tokyo
TEL	03-3300-5231
Homepage URL
Email	ytomi@med.showa-u.ac.jp

Sponsor
Institute	Showa university
Institute
Department

Funding Source
Organization	Showa university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of ShowaUniversity Karasuyama Hospital
Address	6-11-11 Kitakarasuyama, Setagaya-ku, Tokyo
Tel	0333005231
Email	scri@ofc.showa-u.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	2021 Year 08 Month 01 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	2021 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	epidemiological study, prevalence study

Management information
Registered date	2021 Year 06 Month 24 Day
Last modified on	2021 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050973