UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054837 |
|---|---|
| Receipt number | R000062650 |
| Scientific Title | Genetic research in psychiatric disorders |
| Date of disclosure of the study information | 2024/07/10 |
| Last modified on | 2024/07/01 17:02:03 |
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Basic information
Public title
Genetic research in psychiatric disorders
Acronym
Genetic research in psychiatric disorders
Scientific Title
Genetic research in psychiatric disorders
Scientific Title:Acronym
Genetic research in psychiatric disorders
Region
| Japan |
Condition
Condition
various psychiatric disorders (including adverse events caused by psychotropic agents
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The main aim is to analyze various genetic variants to clarify involvements of them in psychiatric diseases from basic and clinical viewpoints.
Basic objectives2
Others
Basic objectives -Others
The 2nd aim is to measure various molecules (including drugs) in peripheral bloods in order to understanding the pathology and treatment strategy in various psychiatric diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Genetic variants and concentrations of molecules
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
| 7 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients:
1. Subjects are treated in the department of psychiatry in Chiba University Hospital (and other hospitals that participate in this research project)
2. Subjects are 7 years or older at the informed consent.
3. Subjects provide the written informed consents by their own decisions following full explanation of the present study. Or their guardian provide the written informed consents in case of subjects that are judged not to understand the contents of this study, or subjects under 18 years old.
Healthy controls:
Subjects are 18 years or older at the informed consent.
Key exclusion criteria
Subjects who are judged to be inappropriate to participate in this study by their physicians or research personnel.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Tomihisa |
| Middle name | |
| Last name | Niitsu |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL
043-222-7171
niitsu@chiba-u.jp
Public contact
Name of contact person
| 1st name | Nobuhisa |
| Middle name | |
| Last name | Kanahara |
Organization
Chiba University Center for Forensic Mental Health
Division name
Division of Clinical Neuroscience
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL
043-222-7171
Homepage URL
kanahara@faculty.chiba-u.jp
Sponsor or person
Institute
-
Institute
Department
Personal name
Funding Source
Organization
-
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of Chiba University Hospital
Address
1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan
Tel
043-222-7171
hsp-seimei@chiba-u.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
| 2024 | Year | 07 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1
Management information
Registered date
| 2024 | Year | 07 | Month | 01 | Day |
Last modified on
| 2024 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062650
