UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014756 |
|---|---|
| Receipt number | R000017099 |
| Scientific Title | A high-resolution MRI analysis in psychiatric disorders |
| Date of disclosure of the study information | 2014/08/05 |
| Last modified on | 2017/02/27 12:39:15 |
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Basic information
Public title
A high-resolution MRI analysis in psychiatric disorders
Acronym
A high-resolution MRI analysis in psychiatric disorders
Scientific Title
A high-resolution MRI analysis in psychiatric disorders
Scientific Title:Acronym
A high-resolution MRI analysis in psychiatric disorders
Region
| Japan |
Condition
Condition
Healthy control
Schizophrenia
Mood disorder
Epilepsy
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the neural basis of psychiatric disorders and establish an objective indicator that is useful for early diagnosis and screening by detailed structural analysis of the brain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
volumes of region of interest
Key secondary outcomes
FA(fractional anisotropy)
PANSS
SAPS
SANS
SES(socioeconomic status)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
MRI,neuropsychological test
Interventions/Control_2
MRI,neuropsychological test
Interventions/Control_3
MRI,neuropsychological test
Interventions/Control_4
MRI,neuropsychological test
Interventions/Control_5
MRI,neuropsychological test
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Right-handed
2) Inpatients or outpatients of Kyushu-university hospital
those who are diagnosed by DSM-4, and ICD-10
Key exclusion criteria
1) Subjects with neurological illness or major head trauma
2) Subjects with alcohol or drug abuse within the past five years
3) Subjects with a verbal intelligence quotient below 75
4) Healthy controls with Axis 1 disorder in themselves or a first-degree relative, which were screened using the Structured Clinical Interview (SCID), non-patient edition.
5) Subjects who have contraindication to MRI
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigenobu Kanba |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Neuropsychiatry
Zip code
Address
Maidashi 3-1-1. Higashi-ku, Fukuoka
TEL
092-641-1151
skanba@npsych.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Onitsuka |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Neuropsychiatry
Zip code
Address
Maidashi 3-1-1. Higashi-ku, Fukuoka
TEL
092-641-1151
Homepage URL
toshiaki@npsych.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 05 | 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
| 2014 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 04 | Day |
Last modified on
| 2017 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017099
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
