UMIN-CTR Clinical Trial

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 Fumitoshi Middle name Last name Kodaka
Organization	The Jikei University School of Medicine
Division name	Department of Psychiatry
Zip code	105-8471
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 Fumitoshi Middle name Last name Kodaka
Organization	The Jikei University School of Medicine
Division name	Department of Psychiatry
Zip code	105-8471
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	The JIkei University School of Medicine
Address	3-25-8, Nishi-shimbashi, Minato-ku
Tel	03-3433-1111
Email	kodaka@jikei.ac.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	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	2018 Year 09 Month 12 Day
Anticipated trial start date	2019 Year 01 Month 08 Day
Last follow-up date	2020 Year 10 Month 01 Day
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	2020 Year 08 Month 09 Day

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