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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000040362 |
Receipt No. | R000046064 |
Scientific Title | Functional neural network associated with Rumination: fMRI investigation |
Date of disclosure of the study information | 2020/05/11 |
Last modified on | 2020/07/14 |
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 |
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Condition | ||
Condition | Healthy control | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Subjective brain response will be examined during rumination task. (2set, 10 min each) | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.Aged >=20 yrs, <=60yrs
2.Subjects who give full consent in the participation of the study. |
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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) |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Keio University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Grant-in-Aid for Scientific Research |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization | Japan |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046064 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |