UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024000 |
|---|---|
| Receipt number | 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 15:32:43 |
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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
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
hjinichi@gmail.com
Sponsor or person
Institute
Keio University School of Medicine, Department of Neuropsychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027630
