UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020468 |
|---|---|
| Receipt number | 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 | 2025/03/11 18:28:49 |
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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
This study aims to establish iPS cells from patients with psychiatric disorders, differentiate them into such as neuronal cells and brain tissues, and identify disease mechanisms while developing a drug evaluation system. Additionally, we will induce and analyze blood vessels, blood cells, the gut, macrophages, and the heart, which are linked to psychiatric disorders and potential comorbidities. Through these efforts, we seek a comprehensive understanding of psychiatric disease pathophysiology.
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
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
ariokay@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Nagoya University, Graduate School of Medicine
Institute
Department
Personal name
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
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
| 2025 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
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
| 2025 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023637
