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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020468
Receipt No. R000023637
Scientific Title Establishment and analyses of induced pluripotent stem (iPS) cells / human-induced neuronal (hiN) cells / induced microglia-like (iMG) cells from tissue, to elucidate the pathogenesis and pathophysiology of mental and developmental disorders.
Date of disclosure of the study information 2016/01/07
Last modified on 2017/07/10

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Basic information
Public title Establishment and analyses of induced pluripotent stem (iPS) cells / human-induced neuronal (hiN) cells / induced microglia-like (iMG) cells from tissue, to elucidate the pathogenesis and pathophysiology of mental and developmental disorders.
Acronym Establishment and analyses of induced pluripotent stem (iPS) cells / human-induced neuronal (hiN) cells / induced microglia-like (iMG) cells from tissue, to elucidate the pathogenesis and pathophysiology of mental and developmental disorders.
Scientific Title Establishment and analyses of induced pluripotent stem (iPS) cells / human-induced neuronal (hiN) cells / induced microglia-like (iMG) cells from tissue, to elucidate the pathogenesis and pathophysiology of mental and developmental disorders.
Scientific Title:Acronym Establishment and analyses of induced pluripotent stem (iPS) cells / human-induced neuronal (hiN) cells / induced microglia-like (iMG) cells from tissue, to elucidate the pathogenesis and pathophysiology of mental and developmental disorders.
Region
Japan

Condition
Condition Multifactorial psychiatric disorders including schizophrenia, depression, bipolar disorders, neurocognitive disorders, eating disorders, anxiety disorders, sleep disorders and autism spectrum disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To study central nervous system disorders using iPS cells, hiN cells and iMG cells derived from psychiatric patients.
Basic objectives2 Others
Basic objectives -Others analysis of pathophysiology
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, depression, bipolar disorders, substancerelated disorders, neurocognitive disorders, eating disorders, anxiety disorders, sleep disorders, autism spectrum disorders et al.) and psychiatrically normal controls
Key exclusion criteria None
Target sample size 30

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 Yuko Arioka
Organization Nagoya University, Graduate School of Medicine
Division name Department of psychiatry
Zip code
Address Showaku, Tsurumai-cho 65, Nagoya
TEL 052-744-2282
Homepage URL
Email ariokay@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 Japanese Governmental office
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
2016 Year 01 Month 07 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 Enrolling by invitation
Date of protocol fixation
2012 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 17 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.

Management information
Registered date
2016 Year 01 Month 07 Day
Last modified on
2017 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023637

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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