UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043155 |
|---|---|
| Receipt number | R000049141 |
| Scientific Title | Exploratory research for blood markers associated with clinical symptoms of psychiatric disorders |
| Date of disclosure of the study information | 2021/01/27 |
| Last modified on | 2023/01/30 15:46:33 |
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Basic information
Public title
Exploratory research for blood markers associated with clinical symptoms of psychiatric disorders
Acronym
Exploratory research for blood markers of psychiatric disorders
Scientific Title
Exploratory research for blood markers associated with clinical symptoms of psychiatric disorders
Scientific Title:Acronym
Exploratory research for blood markers of psychiatric disorders
Region
| Japan |
Condition
Condition
Depressive Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Anxiety Disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Search for blood markers associated with clinical symptoms of psychiatric disorders
Basic objectives2
Others
Basic objectives -Others
Correlation among blood markers and symptom rating scales for psychiatric disorders
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation among nardilysin and symptom rating scales for psychiatric disorders
Key secondary outcomes
Correlation among time-course changes of blood markers and those of symptom rating scales for psychiatric disorders
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have any of the following diseases: Depressive Disorders, Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, and Anxiety Disorders
People who can understand the explanatory document of the research and can obtain written consent.
Key exclusion criteria
Patients who are considered unsuitable as research subjects by the principal investigator or sub-investigator
Patients with severe anemia (hemoglobin less than 6 g/dL, etc.)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ozeki |
| Middle name | |
| Last name | Yuji |
Organization
Shiga University of Medical Science
Division name
Department of Psychiatry
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
+81-77-548-2291
ozeki@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Sumi |
| Middle name | |
| Last name | Yukiyoshi |
Organization
Shiga University of Medical Science
Division name
Department of Psychiatry
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
+81-77-548-2291
Homepage URL
ysumi@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Scholarship donations from Sanyo Chemical Industries, Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science Research Ethics Committee
Address
Seta Tsukinowa-cho, Otsu, Shiga
Tel
+81-77-548-3576
hqrec@belle.shiga-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R2020-141
Org. issuing International ID_1
Shiga University of Medical Science Research Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
滋賀医科大学病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 27 | 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
| 2020 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study.
It may lead to the development of objective biomarkers for psychiatric disorders.
Management information
Registered date
| 2021 | Year | 01 | Month | 27 | Day |
Last modified on
| 2023 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049141
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
