UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of continuity in developmental disorders using multidimensional cognitive functions
Acronym	Investigation of continuity in developmental disorders using multidimensional cognitive functions
Scientific Title	Investigation of continuity in developmental disorders using multidimensional cognitive functions
Scientific Title:Acronym	Investigation of continuity in developmental disorders using multidimensional cognitive functions
Region	Japan

Condition
Condition	Autism spectrum disorder, attention deficit/hyper-activity disorder, healthy adults
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate heterogeneity or homogeneity within developmental disorders using multidimensional cognitive functions.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitive behavioral battery
Key secondary outcomes	Self-report questionnaire

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Diagnosis
Type of intervention	Behavior,custom
Interventions/Control_1	Individuals with autism spectrum disorder
Interventions/Control_2	Individuals with attention deficit/hyper-activity disorder
Interventions/Control_3	healthy adults
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	ASD group 1) Subjects who had received a clinical diagnosis of ASD in outpatient units of the Showa University Karasuyama Hospital. 2) male and female whose age is more than 20 years-old. 3) No serious comorbid psychiatric disorders or medical illness. 4) Capability of informed consent ADHD group 1) Subjects who had received a clinical diagnosis of ADHD in outpatient units of the Showa University Karasuyama Hospital. 2) male and female whose age is more than 20 years-old 3) No serious comorbid psychiatric disorders or medical illness. 4) Capability of informed consent Healthy group 1) male and female whose age is more than 20 years-old 2) No serious psychiatric disorders or medical illness. 3) Capability of informed consent
Key exclusion criteria	Subjects who are judged as unsuitable for participation in this study
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Itahashi
Organization	Showa University
Division name	Medical Institute of Developmental Disabilities Research
Zip code	157-0057
Address	6-11-11 Kitakarasuyama Setagaya-ku, Tokyo
TEL	03-3300-5231
Email	ita3@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Itahashi
Organization	Showa University
Division name	Medical Institute of Developmental Disabilities Research
Zip code	157-0057
Address	6-11-11 Kitakarasuyama Setagaya-ku, Tokyo
TEL	03-3300-5231
Homepage URL
Email	ita3@med.showa-u.ac.jp

Sponsor
Institute	Showa University
Institute
Department

Funding Source
Organization	the Ministry of Education, Culture, Sports, Science and Technology of Japan, the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board of Showa University, Karasuyama Hospital
Address	6-11-11 Kitakarasuyama,Setagaya-ku,Tokyo,157-8577 Japan
Tel	03-3300-5247
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	2019 Year 10 Month 29 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	Enrolling by invitation
Date of protocol fixation	2019 Year 09 Month 03 Day
Date of IRB	2019 Year 09 Month 03 Day
Anticipated trial start date	2019 Year 10 Month 20 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 29 Day
Last modified on	2022 Year 05 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043780