UMIN-CTR Clinical Trial

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
Email	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
Email	aqualife99@hotmail.com

Sponsor
Institute	Hokkaido University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026129