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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030008
Receipt No. R000034251
Scientific Title Description of research on establishment of quantitative clinical index for treatment of psychiatric disorders by noninvasive local cerebral blood flow measurement using near-infrared spectroscopy
Date of disclosure of the study information 2017/11/20
Last modified on 2018/11/19

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Basic information
Public title Description of research on establishment of quantitative clinical index for treatment of psychiatric disorders by noninvasive local cerebral blood flow measurement using near-infrared spectroscopy
Acronym Near-infrared spectroscopy study of psychiatric disorders
Scientific Title Description of research on establishment of quantitative clinical index for treatment of psychiatric disorders by noninvasive local cerebral blood flow measurement using near-infrared spectroscopy
Scientific Title:Acronym Near-infrared spectroscopy study of psychiatric disorders
Region
Japan

Condition
Condition psychiatric disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Establish a new clinical test useful for the diagnosis and treatment of psychiatric disorder
Basic objectives2 Others
Basic objectives -Others Nothing
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analysis data of cerebral blood flow changes
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with psychiatric disorder and healthy control over 10 years old
Key exclusion criteria Nothing
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fukuda Masato
Organization Gunma University
Division name Department of Psychiatry and Neuroscience
Zip code
Address 3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL 027-220-8190
Email fukuda-psy@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fukuda Masato
Organization Gunma University
Division name Department of Psychiatry and Neuroscience
Zip code
Address 3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL 027-220-8190
Homepage URL
Email fukuda-psy@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
Address
Tel
Email

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
2017 Year 11 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2017 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing

Management information
Registered date
2017 Year 11 Month 17 Day
Last modified on
2018 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034251

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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