UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040362 |
|---|---|
| Receipt number | R000046064 |
| Scientific Title | Functional neural network associated with Rumination: fMRI investigation |
| Date of disclosure of the study information | 2020/05/11 |
| Last modified on | 2023/11/13 09:08:56 |
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Basic information
Public title
Functional neural network associated with Rumination: fMRI investigation
Acronym
Functional neural network associated with Rumination: fMRI investigation
Scientific Title
Functional neural network associated with Rumination: fMRI investigation
Scientific Title:Acronym
FR study
Region
| Japan |
Condition
Condition
Healthy control
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of this study is to examine functional brain activity on rumination task in healthy subjects. We will also evaluate cognitive and neuropsychological outcomes.
Basic objectives2
Others
Basic objectives -Others
brain activity
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Brain functional activity and connectivity and during rumination task recorded by fMRI
Key secondary outcomes
-Depression symptoms: Beck Depression Inventory, Quick Inventory of Depressive Symptomatology
-Anxiety symptoms: Generalized Anxiety Disorder -7
- Hopelessness: Beck Hopelessness Scale
-Rumination : Ruminative Response Scale
-Aboidance: Cognitive-Behavioral Avoidance Scale
-Coping: Coping Inventory for Stressful Situations
-Disability: Sheehan Disability Scale
-QOL: EuroQol
-resting state functional connectivity (resting-fMRI)
-Cognition on future-thinking: future-thinking task
-Cognitive function: CABTAB or The Brief Assessment of Cognition in Schizophrenia: BACS-J
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Subjective brain response will be examined during rumination task. (2set, 10 min each)
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Aged >=20 yrs, <=60yrs
2.Subjects who give full consent in the participation of the study.
Key exclusion criteria
1. No history or concurrent DSM-IV Axis I Disorders.
2. No organic brain lesions or major cognitive deficits in a year prior to the screening.
3. No severe or unstable medical illness at screening.
4. Contraindication to MRI (including cardiac pacemaker, claustrophobia)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsuo |
| Middle name | |
| Last name | Nakagawa |
Organization
Keio University School of Medicine
Division name
Keio University Hospital Clinical and Translational Research Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03536332350
anakagawa@keio.jp
Public contact
Name of contact person
| 1st name | Nariko |
| Middle name | |
| Last name | Katayama |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
Homepage URL
narikoktym@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3971
narikoktym@keio.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
| 2020 | Year | 05 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All 40 subjects registered (November 13th. 2023)
Management information
Registered date
| 2020 | Year | 05 | Month | 11 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046064
| Research Plan | |
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| 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 |
