UMIN-CTR Clinical Trial

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	30

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
Email	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
Email	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

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
Email	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	Preinitiation
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

Management information
Registered date	2020 Year 05 Month 11 Day
Last modified on	2020 Year 07 Month 14 Day

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

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