UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034583 |
|---|---|
| Receipt number | R000038826 |
| Scientific Title | Understanding the neuropathophysiology of psychological distress symptoms associated with life events using functional magnetic resonance imaging |
| Date of disclosure of the study information | 2018/10/31 |
| Last modified on | 2022/04/25 09:37:47 |
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Basic information
Public title
Understanding the neuropathophysiology of psychological distress symptoms associated with life events using functional magnetic resonance imaging
Acronym
Understanding the neuropathophysiology of psychological distress symptoms associated with life events using functional magnetic resonance imaging
Scientific Title
Understanding the neuropathophysiology of psychological distress symptoms associated with life events using functional magnetic resonance imaging
Scientific Title:Acronym
Understanding the neuropathophysiology of psychological distress symptoms associated with life events using functional magnetic resonance imaging
Region
| Japan |
Condition
Condition
Bipolar disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying pathology
Basic objectives2
Others
Basic objectives -Others
Clarifying pathology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neural functioning
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Bipolar disorder
Key exclusion criteria
1. Subjects with dementia
2. Subjects with organic mental disorder
3. Subjects with schizophrenia
4. Subjects with post traumatic stress disorder
5. Subjects with intellectual disability
6. Subjects with impending suicide attempt
7. Subjects who have contraindication to MRI
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | Masaomi |
| Middle name | |
| Last name | Iyo |
Organization
Graduate school of medicine and school of medicine, Chiba university
Division name
Department of psychiatry
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
TEL
043-222-7171
ahda4468@chiba-u.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Seki |
Organization
Graduate school of medicine and school of medicine, Chiba university
Division name
Department of psychiatry
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
TEL
043-222-7171
Homepage URL
ahda4468@chiba-u.jp
Sponsor or person
Institute
Chiba university hospital
Institute
Department
Personal name
Funding Source
Organization
Department of psychiatry, graduate school of medicine and school of medicine, Chiba university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital Clinical Research Center
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
Tel
043-222-7171
chibacrc@mac.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
| 2018 | Year | 10 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2018 | Year | 10 | Month | 20 | Day |
Last modified on
| 2022 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038826
