UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009952 |
|---|---|
| Receipt number | 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 11:45:03 |
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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
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
dan19831024showa@yahoo.co.jp
Sponsor or person
Institute
Department of Psychiatry, School of Medicine, Showa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011650
