UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018540
Receipt No. R000021456
Scientific Title Neural activation associated with Future Thinking: fMRI investigation
Date of disclosure of the study information 2015/08/04
Last modified on 2019/07/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Neural activation associated with Future Thinking: fMRI investigation
Acronym FT Study
Scientific Title Neural activation associated with Future Thinking: fMRI investigation
Scientific Title:Acronym FT Study
Region
Japan

Condition
Condition Healthy subject
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 future thinking 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 Bold signal on future thinking task recorded by fMRI
Key secondary outcomes -Depression symptoms: Beck Depression Inventory, Quick Inventory of Depressive Symptomatology
-Dysfunctional attitude: Dysfunctional Attitude Scale,
-Automatic thoughts: Automatic Thoughts Questionnaire Revised,
QOL: EuroQol
-Resilience: Connor-Davidson Resilience Scale
-Personality trait: Temperament and Personality Questionnaire
-Cognitive function: Word Fluency test, Digit Symbol Substitution test

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 response and response time will be examined during future thinking 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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1.Aged >=20 yrs, <=70yrs
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
Middle name
Last name Atsuo Nakagawa, MD, PhD
Organization Keio University School of Medicine
Division name Center for Clinical Research
Zip code
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3235
Email anakagawa@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuo Nakagawa, MD, PhD
Organization Keio University School of Medicine
Division name Center for Clinical Research
Zip code
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3235
Homepage URL
Email anakagawa@keio.jp

Sponsor
Institute Keio Imaging Study Group
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
Address
Tel
Email

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 慶應義塾大学医学部/慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 04 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 Completed
Date of protocol fixation
2015 Year 06 Month 19 Day
Date of IRB
2015 Year 08 Month 05 Day
Anticipated trial start date
2015 Year 08 Month 12 Day
Last follow-up date
2019 Year 06 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 04 Day
Last modified on
2019 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021456

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.