UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041145 |
|---|---|
| Receipt number | R000046989 |
| Scientific Title | Association study between single nucleotide polymorphisms of GSK-3 and a specific group of patients with diagnostic conversion from depression to bipolar disorder and finally to dementia. |
| Date of disclosure of the study information | 2020/07/17 |
| Last modified on | 2024/01/19 09:03:46 |
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Basic information
Public title
Association study between single nucleotide polymorphisms of glycogen synthase kinase -3 (GSK-3) and a specific group of patients with diagnostic conversion from depression to bipolar disorder and finally to dementia.
Acronym
Association study of a specific group of patients with diagnostic conversion from depression to bipolar disorder and finally to dementia.
Scientific Title
Association study between single nucleotide polymorphisms of GSK-3 and a specific group of patients with diagnostic conversion from depression to bipolar disorder and finally to dementia.
Scientific Title:Acronym
Association study of a specific group of patients with diagnostic conversion from depression to bipolar disorder and finally to dementia.
Region
| Japan |
Condition
Condition
Depression, bipolar disorder, dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The primary objective of this study is to investigate differences in genotypic and allelic distributions between the group of dementia with the past history of mood disorder (depression or bipolar disorder) and the group of dementia without.
Basic objectives2
Others
Basic objectives -Others
The secondary objective is to investigate genetic association of the group of patients whose diagnosis is not changed from depression to bipolar disorder.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Genotypic and allelic distributions of GSK-3 single nucleotide polymorphism.
To compare the group of dementia with the past history of mood disorder (depression or bipolar disorder) and the group of dementia without.
Key secondary outcomes
Genotypic and allelic distributions of GSK-3 single nucleotide polymorphism.
To investigate genetic association of the group of patients whose diagnosis is not changed from depression to bipolar disorder.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients suffering from depression, bipolar disorder or dementia who or whose family member give written informed consent to their participation in this study.
Key exclusion criteria
Subjects who are judged as inappropriate one at the discretion of the doctors.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Terao |
Organization
Oita University Faculty of Medicine
Division name
Department of Neuropsychiatry
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama-machi, Yufu-city, Oita prefecture
TEL
097-586-5823
terao@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Hirakawa |
Organization
Oita University Faculty of Medicine
Division name
Department of Neuropsychiatry
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama-machi, Yufu-city, Oita prefecture
TEL
097-586-5823
Homepage URL
hira-hiro@oita-u.ac.jp
Sponsor or person
Institute
Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Scientific reseach funds
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
The Institutional Review Board of Oita University Faculty of Medicine
Address
1-1 Idaigaoka, Hasama-machi,Yufu-city, Oita prefecture
Tel
097-586-6110
gcrcjimu@oita-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
大分大学医学部附属病院（大分県）/ Oita University Hospital (Oita prefecture)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 17 | 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 | 07 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 17 | 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
Study design:Case-control study
Management information
Registered date
| 2020 | Year | 07 | Month | 17 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046989
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| Registered date | File name |
| Research case data | |
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