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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024000
Receipt No. R000027630
Scientific Title Investigation for frontal function in psychiatric disorder, by using functional near-infrared spectroscopy.
Date of disclosure of the study information 2016/09/10
Last modified on 2016/09/10

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Basic information
Public title Investigation for frontal function in psychiatric disorder, by using functional near-infrared spectroscopy.
Acronym Investigation for frontal function in psychiatric disorder, by using functional near-infrared spectroscopy.
Scientific Title Investigation for frontal function in psychiatric disorder, by using functional near-infrared spectroscopy.
Scientific Title:Acronym Investigation for frontal function in psychiatric disorder, by using functional near-infrared spectroscopy.
Region
Japan

Condition
Condition Psychiatric disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the frontal lobe function among the psychiatric disorders, by using functional near-infrared spectroscopy.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. NIRS signals is compared between each subject group.
2. Correlation between the NIRS signals and clinical symptoms.
3. longitudinal change of NIRS signals in each subjects group.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Schizophrenia
Interventions/Control_2 Unipolar depression
Interventions/Control_3 Bipolar depression
Interventions/Control_4 Healthy control
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (i) Clinical diagnosis of Major depressive disorder, Bipolar disorder, or Schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders-IV-TR (DSM-IV-TR)
(ii) Ages over 15
Key exclusion criteria 1) Reported an unstable medical condition
2) Presence of severe suicide ideation,or self-harm.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Mimura
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3829
Email mimura@a7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jinichi Hirano
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3829
Homepage URL
Email hjinichi@gmail.com

Sponsor
Institute Keio University School of Medicine, Department of Neuropsychiatry
Institute
Department

Funding Source
Organization Ministry of health and welfare
Organization
Division
Category of Funding Organization Government offices of other countries
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
2016 Year 09 Month 10 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 Completed
Date of protocol fixation
2012 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 10 Day
Last modified on
2016 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027630

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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