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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018892
Receipt No. R000021863
Scientific Title Genomic study for brain and mental disorders and effectiveness and side effect of pharmacological treatment
Date of disclosure of the study information 2015/09/03
Last modified on 2019/09/05

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Basic information
Public title Genomic study for brain and mental disorders and effectiveness and side effect of pharmacological treatment
Acronym Genomic study for brain and mental disorders and effectiveness and side effect of pharmacological treatment
Scientific Title Genomic study for brain and mental disorders and effectiveness and side effect of pharmacological treatment
Scientific Title:Acronym Genomic study for brain and mental disorders and effectiveness and side effect of pharmacological treatment
Region
Japan

Condition
Condition Multifactorial psychiatric disorders including schizophrenia, mood disorders, neurocognitive disorders, eating disorders, anxiety disorders, sleep disorders, autism spectrum disorders, substance-related disorders, attention-deficit/hyperactivity disorder, learning disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To identify genetic variants implicated in susceptibility to psychiatric disorders and effectiveness and side effect of pharmacological treatment
Basic objectives2 Others
Basic objectives -Others Genomic analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes None
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
0 years-old <=
Age-upper limit
120 years-old >=
Gender Male and Female
Key inclusion criteria Patients with psychiatric disorders (schizophrenia, mood disorders, substance related disorders, neurocognitive disorders, eating disorders, anxiety disorders, sleep disorders, autism spectrum disorders, attention-deficit/hyperactivity disorder, learning disorder) and psychiatrically normal controls
Key exclusion criteria None
Target sample size 2200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Ozaki
Organization Nagoya University, Graduate School of Medicine
Division name Department of psychiatry
Zip code
Address Showaku, Tsurumai-cho 65, Nagoya
TEL 052-744-2282
Email ozaki-n@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Itaru Kushima
Organization Nagoya University
Division name Graduate School of Medicine
Zip code
Address Showaku, Tsurumai-cho 65, Nagoya
TEL 052-744-2282
Homepage URL
Email kushima@med.nagoya-u.ac.jp

Sponsor
Institute Department of Psychiatry, Nagoya University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology of Japan, AMED
Organization
Division
Category of Funding Organization
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
2015 Year 09 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2010 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case-control study.
Study subjects: patients meeting diagnositic criteria for psychiatric disorders (recruited at Nagoya university hospital and its related hospitals) and psychiatrically normal controls.
Genetic variants are measured.

Management information
Registered date
2015 Year 09 Month 02 Day
Last modified on
2019 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021863

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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