UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038424 |
|---|---|
| Receipt number | R000043785 |
| Scientific Title | GABA tuning of brain activity in adolescence |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2020/10/29 11:33:11 |
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Basic information
Public title
GABA tuning of brain activity in adolescence
Acronym
GABA tuning of brain activity in adolescence
Scientific Title
GABA tuning of brain activity in adolescence
Scientific Title:Acronym
GABA tuning of brain activity in adolescence
Region
| Japan |
Condition
Condition
developmental disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the current project is to investigate the tuning role of GABA on the brain activity of the anterior cingulate cortex during the executive function task
Basic objectives2
Others
Basic objectives -Others
measuring GABA and fMRI during rest and task
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
T1, T2, resting state fMRI, DTI, task fMRI, resting state H-MRS, task fMRS
Key secondary outcomes
JART, BDI-II, TAS, LSAS, WISC
age, sex, birth information, SES
SRS, CCC-2, CBCL
SDQ, NRI, Vineland
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
| 10 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals whose diagnoses is either ASD or ADHD at Showa University
No psychiatric or medical complication
Participants need to provide ascent
Parents or guardians needs to fully understand the protocol and agree to take part in
Key exclusion criteria
Judged by physicians
People contraindicated to MRI
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | Y |
| Last name | Aoki |
Organization
Showa University
Division name
Medical Institute of Developmental Disabilities Research
Zip code
157-8577
Address
6-11-11 Kitakarasuyama Setagaya, Tokyo, JAPAN
TEL
03-3300-5231
yuaoki-tky@umin.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
157-8577
Address
6-11-11 Kitakarasuyama Setagaya, Tokyo, JAPAN
TEL
03-3300-5231
Homepage URL
yuaoki-tky@umin.ac.jp
Sponsor or person
Institute
KAKENHI
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB at Showa University Karasuyama Hospital
Address
6-11-11 Kitakarasuyama Setagaya, Tokyo, JAPAN
Tel
03-3300-5247
kawashima@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 | 11 | 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
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2019 | Year | 10 | Month | 29 | Day |
Last modified on
| 2020 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043785
