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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038424
Receipt No. R000043785
Scientific Title GABA tuning of brain activity in adolescence
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/29

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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
Email middr@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 157-8577
Address 6-11-11 Kitakarasuyama Setagaya, Tokyo, JAPAN
TEL 03-3300-5231
Homepage URL
Email middr@med.showa-u.ac.jp

Sponsor
Institute KAKENHI
Institute
Department

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
Email 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
2019 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043785

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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