UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023603 |
|---|---|
| Receipt number | R000027177 |
| Scientific Title | A Study on the large-scale Neural Networks of Psychiatric disorders |
| Date of disclosure of the study information | 2016/08/15 |
| Last modified on | 2016/08/12 14:32:19 |
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Basic information
Public title
A Study on the large-scale Neural Networks of Psychiatric disorders
Acronym
A Study on the large-scale Neural Networks of Psychiatric disorders
Scientific Title
A Study on the large-scale Neural Networks of Psychiatric disorders
Scientific Title:Acronym
A Study on the large-scale Neural Networks of Psychiatric disorders
Region
| Japan |
Condition
Condition
Schizophrenia
Autism spectrum disorder
Major depressive disorder
Bipolar disorders
Healthy control
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is a study of patients with psychiatric disorders, which examines the failure of connectivity between structural and functional large-scale neural networks related to psychiatric symptoms, cognitive functions, and social functions (objective and subjective assessments), using diffusion tensor imaging (DTI) and resting-state functional MRI (rs-fMRI).
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fMRI,DTI
Key secondary outcomes
Psychiatric symptoms, cognitive functions, and social functions (objective and subjective assessments)
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
fMRI,DTI,neuropsychological test
Interventions/Control_2
fMRI,DTI,neuropsychological test
Interventions/Control_3
fMRI,DTI,neuropsychological test
Interventions/Control_4
fMRI,DTI,neuropsychological test
Interventions/Control_5
fMRI,DTI,neuropsychological test
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who are diagnosed with unipolar melancholic depression, bipolar disorder, schizophrenia, or autistic spectrum disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
2. Patients between the ages of 16-65.
3. Patients who scored higher than 70 of estimated premorbid IQ in JART (Japanese Adult Reading Test).
4. Patients (their parents or guardians, in the case of minors) who have given informed consent to participate in research.
Key exclusion criteria
1.Patients who have strong suicidal ideation.
2.Patients who are currently being treated for alcohol/drug abuse.
3.Patients with a history of head injury with loss of consciousness.
4.Patients who have serious physical illness.
5.Patients who cannot be examined by MRI (due to metallic implants, tattoos, or claustrophobia).
6.Patients who were determined by their doctors or head researchers to be inappropriate for research subjects for other reasons.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Kaneko |
Organization
Tottori University Faculty of Medicine
Division name
Division of Neuropsychiatry, Department of Brain and Neuroscience
Zip code
Address
36-1 Nishi-cho, Yonago, Tottori
TEL
0859-38-6547
kaneko@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shenghong Pu |
Organization
Tottori University Faculty of Medicine
Division name
Division of Neuropsychiatry, Department of Brain and Neuroscience
Zip code
Address
36-1 Nishi-cho, Yonago, Tottori
TEL
0859-38-6547
Homepage URL
pshh0517@yahoo.co.jp
Sponsor or person
Institute
Tottori University faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology, JAPAN
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Tottori University Faculty of Medicine
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
鳥取大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 15 | 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
| 2016 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 15 | 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
| 2016 | Year | 08 | Month | 12 | Day |
Last modified on
| 2016 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027177
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
