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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002788
Receipt No. R000003389
Scientific Title Elucidation of pathogenesis of schizophrenia using biological and symtomatological methods
Date of disclosure of the study information 2009/11/20
Last modified on 2010/06/24

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Basic information
Public title Elucidation of pathogenesis of schizophrenia using biological and symtomatological methods
Acronym Elucidation of pathogenesis of schizophrenia using biological and symtomatological methods
Scientific Title Elucidation of pathogenesis of schizophrenia using biological and symtomatological methods
Scientific Title:Acronym Elucidation of pathogenesis of schizophrenia using biological and symtomatological methods
Region
Japan

Condition
Condition schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Elucidation of pathogenesis of schizophrenia using biological and symtomatological methods
Basic objectives2 Others
Basic objectives -Others Clarifying the pathogenesis of schizophrenia using genetical, symptomatological, physiological and pharmacological approaches
Trial characteristics_1
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Candidate genes, exploratory eye movement, PANSS, SAPS, DIEPSS
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

Not applicable
Gender Male and Female
Key inclusion criteria Schizophrenia patients diagnosed by ICD-10
Key exclusion criteria Psychiatric patient who has a history of alcohol or illicit substance abuse, head injury, convulsion, or neurologic or ophthalmologic disorder.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sakae Takahashi
Organization Nihon University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 30-1 Oyaguchi- Kamicho, Itabashi-ku, Tokyo 173-8610, Japan
TEL +81-3-3972-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nihon University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 30-1 Oyaguchi- Kamicho, Itabashi-ku, Tokyo 173-8610, Japan
TEL +81-3-3972-8111
Homepage URL
Email

Sponsor
Institute Nihon University School of Medicine
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Jiundo-Naika Hospital
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 日本大学医学部附属板橋病院(東京都)、慈雲堂内科病院(東京都)

Other administrative information
Date of disclosure of the study information
2009 Year 11 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 Enrolling by invitation
Date of protocol fixation
2009 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Clarifying the pathogenesis of schizophrenia using genetical, symptomatological, physiological and pharmacological approaches

Management information
Registered date
2009 Year 11 Month 20 Day
Last modified on
2010 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003389

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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