UMIN-CTR Clinical Trial

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	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
Email	yuaoki-tky@umin.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	2020 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