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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030903
Receipt No. 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 2018/01/20

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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 Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Gene
Interventions/Control_1 10 cc of blood is collected before the start of usual treatment(TAU) ,4 weeks and 12 weeks after treatment.
Interventions/Control_2 EEG test before and 2 weeks after the start of treatment
Interventions/Control_3 MRI test before and 12 weeks after the start of treatment
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
Middle name
Last name Masaki Kato
Organization Kansai Medical University
Division name Department of Neuropsychiatry
Zip code
Address 10-15 Fumizono-cho Moriguchi Osaka
TEL 06-6992-1001
Email katom@takii.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Kato
Organization Kansai Medical University
Division name Department of Neuropsychiatry
Zip code
Address 10-15 Fumizono-cho Moriguchi Osaka
TEL 06-6992-1001
Homepage URL
Email katom@takii.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2018 Year 01 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 20 Day
Last modified on
2018 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035287

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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