UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038419 |
|---|---|
| Receipt number | R000043780 |
| Scientific Title | Investigation of continuity in developmental disorders using multidimensional cognitive functions |
| Date of disclosure of the study information | 2019/10/29 |
| Last modified on | 2022/05/01 09:47:52 |
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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
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
ita3@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043780
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
