UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022670 |
|---|---|
| Receipt number | R000026129 |
| Scientific Title | Mean kurtosis alterations of cerebral white matter in patients with schizophrenia revealed by diffusion kurtosis imaging |
| Date of disclosure of the study information | 2016/06/10 |
| Last modified on | 2022/06/13 09:13:28 |
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Basic information
Public title
Mean kurtosis alterations of cerebral white matter in patients with schizophrenia revealed by diffusion kurtosis imaging
Acronym
MK alterations of cerebral WM in patients with schizophrenia revealed by diffusion kurtosis imaging
Scientific Title
Mean kurtosis alterations of cerebral white matter in patients with schizophrenia revealed by diffusion kurtosis imaging
Scientific Title:Acronym
MK alterations of cerebral WM in patients with schizophrenia revealed by diffusion kurtosis imaging
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of the present study were to examine the differences of MK values between patients with schizophrenia and healthy control subjects using voxel-based analysis.
Basic objectives2
Others
Basic objectives -Others
To examine correlation between the MK values and the severity of clinical symptoms, especially positive symptoms, in schizophrenia.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Alteration of MK and FA values.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
schizophrenia was diagnosed by a research psychiatrist ( H.N. 8 years of experience in psychiatry) based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) using the Structured Clinical Interview for DSM-IV Axis I disorders (SCID-I).
Key exclusion criteria
any absolute contraindication to MRI, comorbidity of axis I or II disorders, history of diseases that might affect WM integrity (i.e., prior head injury, cerebrovascular disorder, or degenerative disease), existence of past substance abuse or dependency, pregnancy, or a high risk of suicide.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Kusumi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Dept. of Psychiatry
Zip code
060-8638
Address
North15, West7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
0117065160
aqualife99@hotmail.com
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Narita |
Organization
Hokkaido University Graduate School of Medicine
Division name
Dept. of Psychiatry
Zip code
060-8638
Address
North15, West7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
0117065160
Homepage URL
aqualife99@hotmail.com
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Psychiatry, Hokkaido University Graduate School of Medicine
Address
North15, West7, Sapporo, Japan
Tel
011-706-5160
aqualife99@hotmail.com
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 | 06 | Month | 10 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Compared to FA values, voxels with MK decrease were more widespread across bilateral cerebral the WM of patients with schizophrenia.
Management information
Registered date
| 2016 | Year | 06 | Month | 08 | Day |
Last modified on
| 2022 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026129
