UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035479 |
|---|---|
| Receipt number | R000040422 |
| Scientific Title | Evaluation of depressive symptom using effort discounting |
| Date of disclosure of the study information | 2019/01/08 |
| Last modified on | 2020/08/09 16:39:54 |
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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 | 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
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
kodaka@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040422
