UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030903 |
|---|---|
| Receipt number | R000035287 |
| Scientific Title | Search and verification test of genome and bio-markers for the purpose of constructing an individualized treatment algorithm for psychiatric disorders |
| Date of disclosure of the study information | 2018/01/20 |
| Last modified on | 2020/01/21 10:57:30 |
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Basic information
Public title
Search and verification test of genome and bio-markers for the purpose of constructing an individualized treatment algorithm for psychiatric disorders
Acronym
Precision medicine research in psychiatric disorders
Scientific Title
Search and verification test of genome and bio-markers for the purpose of constructing an individualized treatment algorithm for psychiatric disorders
Scientific Title:Acronym
Precision medicine research in psychiatric disorders
Region
| Japan |
Condition
Condition
Depression, bipolar disorder, schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
It aims to create an individualized treatment algorithm in depression, bipolar disorder, schizophrenia treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depressive state; Hamilton Depression Rating Scale Japanese version (HAM-D)
Schizophrenia; positive / negative symptom scale (PANSS)
Manic state; Young manic rating scale (YMRS)
Cognitive function
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.person diagnosed with depression, bipolar disorder, schizophrenia with DSM - IV - TR
2. Persons whose age is between 18 and 80
3. Person who satisfies either 14 points of HAM-D or 60 points of PANSS
4. Hospitalization, outpatient and sex are not required
5. Person who gained consent by free will with document
Key exclusion criteria
1.DSM-IV-TR has obvious I / II axis disorder other than depression, bipolar disorder, schizophrenia
2.Those who carried out ECT treatment within three months prior to the start of screening
3.People in a coma state
4.Persons under the strong influence of central nervous system depressants such as barbituric acid derivatives and anesthetics
5.Adrenaline administered person
6.Pregnancy and potential pregnancy, breast-feeding7. Person who judged that the attending physician has a problem with the consent ability
8.Persons with severe physical disorders
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kato |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry
Zip code
570-8506
Address
10-15 Fumizono-cho Moriguchi Osaka
TEL
06-6992-1001
katom@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Masaki Kato |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry
Zip code
570-8506
Address
10-15 Fumizono-cho Moriguchi Osaka
TEL
06-6992-1001
Homepage URL
katom@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Mostly self-procurement
Ministry of education
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Medical Ethics Review Committee
Address
shinmachi 2-3-1 HIrakata-city, Osaka
Tel
0669921001
pangaea1975@gmail.com
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
| 2018 | Year | 01 | Month | 20 | 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
| 2017 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is precision medicine for depression, bipolar disorder and schizophrenia based on clinical background, genetic polymorphism, blood biomarkers such as inflammation-related factors and neuroplasticity-related factors, quantitative EEG of depression, bipolar disorder and schizophrenia, depression.
Management information
Registered date
| 2018 | Year | 01 | Month | 20 | Day |
Last modified on
| 2020 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035287
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
