UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026411 |
|---|---|
| Receipt number | R000030241 |
| Scientific Title | Investigation of clinical biomarkers reflecting the neurological basis of depressive symptoms and their usefulness in novel therapeutic technique |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2021/03/09 16:57:57 |
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Basic information
Public title
Investigation of clinical biomarkers reflecting the neurological basis of depressive symptoms and their usefulness in novel therapeutic technique
Acronym
Investigation of clinical biomarkers of depressive symptoms and their usefulness
Scientific Title
Investigation of clinical biomarkers reflecting the neurological basis of depressive symptoms and their usefulness in novel therapeutic technique
Scientific Title:Acronym
Investigation of clinical biomarkers of depressive symptoms and their usefulness
Region
| Japan |
Condition
Condition
depressive symptoms
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploring clinical biomarkers useful for diagnosis and treatment of depressive symptoms.
Basic objectives2
Others
Basic objectives -Others
nothing
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Group comparison of psychological examination and brain imaging between psychiatric disorder patients with depressed symptoms and healthy comparison.
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a. or b.
A. Among patients visiting or hospitalized at Gunma University Hospital who has been diagnosed as a corresponding psychiatric disorder in accordance with DSM-5 and has been informed of the disorder or a state.
B. Normal people who are free from mental illness and neurological disorder in the present and past.
Key exclusion criteria
1) Under 15 years old
2) Pacemakers, claustrophobia etc. MRI equipment contraindicated
3) Merging serious physical disorders
4) Measures Inpatients
5) Emergency hospitalized patients
6) Others judged inappropriate as subjects by doctors
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Fukuda |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Psychiatry and Neuroscience
Zip code
371-8511
Address
3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8180
fukuda-psy@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Takei |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Psychiatry and Neuroscience
Zip code
371-8511
Address
3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8190
Homepage URL
tyuichi@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Strategic Research Program for Train science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
showa 3-39-22
Tel
0272207111
takeiyuichi@gmail.com
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 | 04 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
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 | 03 | Month | 06 | Day |
Last modified on
| 2021 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030241
