UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037843 |
|---|---|
| Receipt number | R000043145 |
| Scientific Title | Symptom-based research in psychiatric disorders |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2019/08/29 12:24:37 |
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Basic information
Public title
Symptom-based research in psychiatric disorders
Acronym
Symptom-based research in psychiatric disorders
Scientific Title
Symptom-based research in psychiatric disorders
Scientific Title:Acronym
Symptom-based research in psychiatric disorders
Region
| Japan |
Condition
Condition
psychiatric disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
symptom based-approach in psychiatric disorders.
Basic objectives2
Others
Basic objectives -Others
To measure psychiatric symptoms in detail, we apply high resolution MRI, psychological test and assessment for daily activities.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
structural and functional alteration using high resolution MRI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
High resolution MRI
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patient with psychiatric symptoms
Key exclusion criteria
Has a contraindication to undergoing MRI
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Oishi |
Organization
Kyoto University
Division name
Graduate School of Medicine, Medical Innovation Center
Zip code
6068507
Address
53 Shogoin-Kawaharacho, Kyoto
TEL
0753667417
noishi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Ubukata |
Organization
Kyoto University
Division name
Graduate School of Medicine, Medical Innovation Center
Zip code
6068507
Address
53 Shogoin-Kawaharacho, Kyoto
TEL
0753667417
Homepage URL
ubukata@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University, Graduate School of Medicine, Medical Innovation Center
Institute
Department
Personal name
Funding Source
Organization
SHIONOGI & CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto university graduate school and faculty of medicine, Kyoto university hospital ethics committe
Address
Konoecho, Kyoto
Tel
0757534680
ethcom@kuhp.kyoto-u.ac.jp
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
| 2019 | Year | 10 | Month | 01 | 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
| 2019 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 29 | Day |
Last modified on
| 2019 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043145
