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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009952
Receipt No. R000011650
Scientific Title Functional MRI study for altruism of schizophrenic patient
Date of disclosure of the study information 2013/02/04
Last modified on 2013/11/10

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Basic information
Public title Functional MRI study for altruism of
schizophrenic patient

Acronym Functional MRI study for altruism
Scientific Title Functional MRI study for altruism of
schizophrenic patient

Scientific Title:Acronym Functional MRI study for altruism
Region
Japan

Condition
Condition schizophrenia
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To uncover the localization of brain function for altruism
Basic objectives2 Others
Basic objectives -Others relation between weakening of
To uncover relation between altruism for schizophrenic patient and lesion of the localization of brain for altruism
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The Self Report Altruism Scale
Aid norm conscious scale
Key secondary outcomes Japanese version of subjective feeling of happiness scale
MMPI
NEO Five-Factor Inventory
Japanese Adult Reading Test
Japanese version of WHO QOL26
EQ(Emotional Intelligence Quotient)
PANSS(Positive and Negative Syndrome
Scale)
GAF(The Global Assessment of
Functioning)
SOFAS(Social and Occupational
Functioning Assessment Scale)
HAM-D
Social Functioning Scale

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment Other
Interventions/Control_1 a wide variety of evaluation scale
Interventions/Control_2 Functional MRI
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
20 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria Patient group
Schizophrenic patient who is outpatient visit or hospital stay in Karasuyama Hospital of Showa University
Right handedness
Person who can collaborate the MRI scans
Person who gave informed consent in writing by himself

Control group
Right handedness
Person who can collaborate the MRI scans
Person who gave informed consent in writing by himself



Key exclusion criteria Patient group
Person who have mental disorder or anamnestic history which is relevant to the axis 1 and 2 of DSM-4-TR
Person who have personality disorder which is relevant to the axis 2 of DSM-4-TR and mental retardation
Person who have anamnestic history of internal medicine and department of neurology
Person who have metal in body
Person who is pregnant female
Person who is not unsuitable for the MRI scans
Compulsory hospitalization patient

Control group
Person who have mental disorder or anamnestic history which is relevant to the axis 1 and 2 of DSM-4-TR
Person who have anamnestic history of internal medicine and department of neurology
Person who have metal in body
Person who is pregnant female
Person who is not unsuitable for the MRI scans



Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Tani
Organization Department of Psychiatry, School of Medicine, Showa University
Division name Showa University Karasuyama Hospital
Zip code
Address 6-11-11,kitakarasuyama,setagaya-ku,Tokyo
TEL 03-3300-5231
Email showa-ctc@ofc.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dan Nakamura
Organization Department of Psychiatry, School of Medicine, Showa University
Division name Showa University Karasuyama Hospital
Zip code
Address 6-11-11,kitakarasuyama,setagaya-ku,Tokyo
TEL 03-3300-5231
Homepage URL
Email dan19831024showa@yahoo.co.jp

Sponsor
Institute Department of Psychiatry, School of Medicine, Showa University
Institute
Department

Funding Source
Organization Department of Psychiatry, School of Medicine, Showa University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 昭和大学附属烏山病院(東京都)         Showa University Karasuyama Hospital

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 04 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 Preinitiation
Date of protocol fixation
2013 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 04 Day
Last modified on
2013 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011650

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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