UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016097 |
|---|---|
| Receipt number | R000018693 |
| Scientific Title | Biological tests for major depressive disorder that involve leukocyte gene expression assays. |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2015/01/01 22:49:40 |
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Basic information
Public title
Biological tests for major depressive disorder that involve leukocyte gene expression assays.
Acronym
Biological tests for major depressive disorder
Scientific Title
Biological tests for major depressive disorder that involve leukocyte gene expression assays.
Scientific Title:Acronym
Biological tests for major depressive disorder
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The goal of present work was to develop and test the performance of a composite, multi-assay diagnostic test for MDD based on the leukocyte gene expression profiles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
sensitivity and specificity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Biological tests for major depressive disorder that involve leukocyte gene expression assays.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with major depressive disorder.
Key exclusion criteria
Exclusion criteria for MDDs have not used non-steroidal anti-inflammatory agents, steroids, antipsychotic medications, and anticonvulsants at least past 2 months.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuro Ohmori |
Organization
Course of Integrated Brain Sciences, University of Tokushima School of Medicine
Division name
Department of Psychiatry
Zip code
Address
3-18-15 Kuramoto-cho Tokushima-shi
TEL
+81-86-633-7130
ohmori@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Iga |
Organization
Course of Integrated Brain Sciences, University of Tokushima School of Medicine
Division name
Department of Psychiatry
Zip code
Address
3-18-15 Kuramoto-cho Tokushima-shi
TEL
+81-86-633-7130
Homepage URL
igajunichi@hotmail.com
Sponsor or person
Institute
Course of Integrated Brain Sciences, University of Tokushima School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Health and Labor Science Research Grant from the Japanese Ministry of Health, Labor and welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
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
Tokushima University Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | 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
Completed
Date of protocol fixation
| 2005 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 01 | Day |
Last modified on
| 2015 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018693
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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