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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035479
Receipt No. R000040422
Scientific Title Evaluation of depressive symptom using effort discounting
Date of disclosure of the study information 2019/01/08
Last modified on 2019/01/08

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Basic information
Public title Evaluation of depressive symptom using effort discounting
Acronym Evaluation of depressive symptom using effort discounting
Scientific Title Evaluation of depressive symptom using effort discounting
Scientific Title:Acronym Evaluation of depressive symptom using effort discounting
Region
Japan

Condition
Condition Major depressive disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to evaluate whether effort discounting is used for surrogate marker of depressive symptom.
Basic objectives2 Others
Basic objectives -Others The purpose of the study is to investigate the relation between metrics of effort discounting and sub scale of depressive symptom.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Inter-subject difference of discounting factor measured by Handgrip Force task between patients with major depressive disorder and healthy volunteers.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patient
1) patients who receive treatment at outpatient/inpatient section of Department of Psychiatry, Jikei University School of Medicine.
2) patients who met criteria of major depressive disorder according to DSM-5

Healthy volunteer
1) Men and Women
Key exclusion criteria Patient
1) patients who have a past history of psychotic episode, obsessive compulsive disorder, post traumatic stress disorder and/or eating disorder.
2) patients who have a past history of neurological disease and/or organic brain disorder.
3) patients who have a history of drug and/or alcohol dependency
4) patients who have severe physical disease such as metabolic, endocrine disease.
5) patients who have severe suicidal ideation.
6) patients who need person execute surrogate decision making of the patients.

Healthy volunteers
1) persons who have a history of neurological disease and/or psychiatric disorder.
2) persons who receive psychotripic drugs.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumitoshi Kodaka
Organization The Jikei University School of Medicine
Division name Department of Psychiatry
Zip code
Address 3-18-13 Nishi-shinbashi, Minato-ku, Tokyo, Japan
TEL +81-3-3433-1111
Email kodaka@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumitoshi Kodaka
Organization The Jikei University School of Medicine
Division name Department of Psychiatry
Zip code
Address 3-18-13 Nishi-shinbashi, Minato-ku, Tokyo, Japan
TEL +81-3-3433-1111
Homepage URL
Email kodaka@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 08 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We are planning to measure effort discounting

Management information
Registered date
2019 Year 01 Month 08 Day
Last modified on
2019 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040422

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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