UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022614 |
|---|---|
| Receipt number | R000026066 |
| Scientific Title | Performance evaluation of portable near-infrared spectroscopy |
| Date of disclosure of the study information | 2016/06/05 |
| Last modified on | 2017/12/27 12:40:50 |
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Basic information
Public title
Performance evaluation of portable near-infrared spectroscopy
Acronym
Performance evaluation of portable near-infrared spectroscopy
Scientific Title
Performance evaluation of portable near-infrared spectroscopy
Scientific Title:Acronym
Performance evaluation of portable near-infrared spectroscopy
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Performance evaluation of portable near-infrared spectroscopy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Homology with the conventional near-infrared spectroscopy
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
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of brain function by portable near-infrared spectroscopy
Interventions/Control_2
Healthy control
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Diagnosis of major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5)
2) 20 to 65 years old of age
Key exclusion criteria
1)Presence of any unstable physical illness
2)Presence of severe suicide ideation, or self harm
Target sample size
60
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, 160-8582, Japan.
TEL
03-5363-3829
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, 160-8582, Japan.
TEL
03-5363-3829
Homepage URL
hjinichi@gmail.com
Sponsor or person
Institute
Department of Neuropsychiatry,Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Brain Energy Inc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 06 | Month | 05 | 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
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | 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
Management information
Registered date
| 2016 | Year | 06 | Month | 05 | Day |
Last modified on
| 2017 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026066
