UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025549 |
|---|---|
| Receipt number | R000029389 |
| Scientific Title | Study for pathophysiology and diagnostics of mental disorders using MRI |
| Date of disclosure of the study information | 2017/01/05 |
| Last modified on | 2017/01/05 19:21:30 |
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Basic information
Public title
Study for pathophysiology and diagnostics of mental disorders using MRI
Acronym
Study for pathophysiology and diagnostics of mental disorders using MRI
Scientific Title
Study for pathophysiology and diagnostics of mental disorders using MRI
Scientific Title:Acronym
Study for pathophysiology and diagnostics of mental disorders using MRI
Region
| Japan |
Condition
Condition
schizophrenia, manic-depressive disorder etc.
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Claryfying pathophysiology and developing diagnostic markers of mental disorders including schizophrenia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)MRI:
activation study, resting state MRI, DTI, MRS
(2)behavioral experiments:
Sense of agency task (Keio method)
Temporal order judgment task (Keio method)
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
schizophrenia, depression, Mania, bipolar disorder(diagnosed by DSM4 or 5, ICD-10)
Key exclusion criteria
(1)patients who are in severe mental states
(2)Patients with severe physical illnesses
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaki Maeda |
Organization
Komagino Hospital
Division name
Center for Psychiatry and Behavioral Science
Zip code
Address
273 Uratakao-cho, Hachioji-shi, Tokyo, Japan
TEL
042-663-2222
takaki@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaki Maeda |
Organization
Komagino Hospuital
Division name
Center for Psychiatry and Behavioral Science
Zip code
Address
273 Uratakao-cho, Hachioji-shi, Tokyo, Japan
TEL
042-663-2222
Homepage URL
takaki@keio.jp
Sponsor or person
Institute
Komagino Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
駒木野病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | 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
Date of protocol fixation
| 2014 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We intended crosssectional and longitudinal study of self-disturbances( abnormal sense of agency) in schizophrenia, using MRI(activation study, resting MRI, DTI, MRS).
Management information
Registered date
| 2017 | Year | 01 | Month | 05 | Day |
Last modified on
| 2017 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029389
| 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 |
