UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038699 |
|---|---|
| Receipt number | R000044117 |
| Scientific Title | Development of biomarkers for psychiatric disorders (schizophrenia, mood disorders, dementia) by cerebrospinal fluid |
| Date of disclosure of the study information | 2021/11/27 |
| Last modified on | 2025/12/02 14:34:32 |
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Basic information
Public title
Development of biomarkers for psychiatric disorders (schizophrenia, mood disorders, dementia) by cerebrospinal fluid
Acronym
Development of biomarkers for psychiatric disorders (schizophrenia, mood disorders, dementia) by cerebrospinal fluid
Scientific Title
Development of biomarkers for psychiatric disorders (schizophrenia, mood disorders, dementia) by cerebrospinal fluid
Scientific Title:Acronym
Development of biomarkers for psychiatric disorders (schizophrenia, mood disorders, dementia) by cerebrospinal fluid
Region
| Japan |
Condition
Condition
Schizophrenia, mood disorder, dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop cerebrospinal fluid markers for schizophrenia, mood disorders, and dementia.
Basic objectives2
Others
Basic objectives -Others
To investigate biomarkers of cerebrospinal fluid in schizophrenia, mood disorders, and dementia by correlation with symptom evaluation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive and negative symptom rating scale (PANSS) for schizophrenia, Hamilton depression rating scale (GRID-HAM-D) for mood disorders, or Young Mania Rating Scale, and Mini Mental State Examination (MMSE) for dementia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Cerebrospinal fluid examination
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients with schizophrenia, mood disorders and dementia
Key exclusion criteria
Exclude high-risk patients such as Bleeding tendency, heparin use, anesthesia allergies,increased brain pressure, or patients judged to be inappropriate by a doctor.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Monji |
Organization
Faculty of Medicine, Saga University
Division name
Department of Psychiatry
Zip code
849-8501
Address
5-1-1, Nabeshima, Saga
TEL
0952-34-2304
amonji@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tateishi |
Organization
Saga University Hospital
Division name
Department of Psychiatry
Zip code
849-8501
Address
5-1-1, Nabeshima, Saga
TEL
0952-34-2304
Homepage URL
tateishh@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethics Committee Saga University Hospital
Address
5-1-1 Nabeshima, Saga City, Saga
Tel
0952-34-3357
kenkyu-shinsei@ml.cc.saga-u.ac.jp
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
| 2021 | Year | 11 | Month | 27 | Day |
Related information
URL releasing protocol
https://clinicalresearch.hospital.med.saga-u.ac.jp/rinri/Apply/show.aspx?TYPE=0&ID=331
Publication of results
Unpublished
Result
URL related to results and publications
https://clinicalresearch.hospital.med.saga-u.ac.jp/rinri/Apply/show.aspx?TYPE=4&ID=2547
Number of participants that the trial has enrolled
8
Results
We found cases in which patients with depression were diagnosed with Alzheimer's disease or mild cognitive impairment due to Alzheimer's disease. We also found cases in which dementia was ruled out and a diagnosis of depression was made, making it possible to differentiate between depression and dementia.
Results date posted
| 2025 | Year | 12 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All eight are women.
Participant flow
Cerebrospinal fluid testing was performed on patients admitted to our department with mood disorders or dementia, who met the exclusion criteria, and who provided consent.
Adverse events
none.
Outcome measures
A beta 42 and p-tau concentrations in cerebrospinal fluid.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 27 | Day |
Last modified on
| 2025 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044117
