UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050258 |
|---|---|
| Receipt number | R000057225 |
| Scientific Title | Investigating the endophenotype of ADHD |
| Date of disclosure of the study information | 2023/02/07 |
| Last modified on | 2023/02/07 17:57:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigating the endophenotype of ADHD
Acronym
Investigating the endophenotype of ADHD
Scientific Title
Investigating the endophenotype of ADHD
Scientific Title:Acronym
Investigating the endophenotype of ADHD
Region
| Japan |
Condition
Condition
Individuals with ADHD and their first-degree relatives
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the neurocognitive and neuroimaging endophenotype of ADHD
Basic objectives2
Others
Basic objectives -Others
Correlation between cognitive function and neuroimging marker
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Common neuroimaging and neurocognitive marker of individuals with ADHD and their first-degree relatives
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
MRI data acquisition
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals with ADHD diagnosed by using DSM-5 and their first-degree relatives
Healthy individuals
Key exclusion criteria
Severe neurological disease, current and past history of alchol abuse, pregnancy, severe psysical disease
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | hirofumi |
| Middle name | |
| Last name | tomiyama |
Organization
Kyushu University
Division name
Psychiatry
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka-shi
TEL
092-642-5640
tomiyama.hirofumi.765@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | hirofumi |
| Middle name | |
| Last name | tomiyama |
Organization
Kyushu University
Division name
Psychiatry
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka-shi
TEL
092-642-5640
Homepage URL
bt.group@icloud.com
Sponsor or person
Institute
Kyushu-University
Institute
Department
Personal name
Funding Source
Organization
JSPS Kaken
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
Kyushu University Hospital Ethics Committee
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka-shi
Tel
092-641-1151
byskenkyu@jimu.kyushu-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
| 2023 | Year | 02 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 02 | Month | 07 | Day |
Last modified on
| 2023 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057225
