UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052716 |
|---|---|
| Receipt number | R000060152 |
| Scientific Title | Investigation of the effects of depression on taste. |
| Date of disclosure of the study information | 2023/11/10 |
| Last modified on | 2023/11/07 14:52:14 |
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Basic information
Public title
Investigation of the effects of depression on taste.
Acronym
Investigation of the effects of depression on taste.
Scientific Title
Investigation of the effects of depression on taste.
Scientific Title:Acronym
Investigation of the effects of depression on taste.
Region
| Japan |
Condition
Condition
depression
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using taste thresholds as the primary endpoint, this study aims to clarify the presence and characteristics of taste disorders in depressed patients. The study also aims to clarify the effects of taste recall training on the taste perception reduced by depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Three days of taste recall training is given to healthy adults and depressed patients to assess changes in taste perception thresholds.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
3-day taste recall training
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
20 healthy adults and 20 depressed patients without a diagnosis of taste disorder who wished to participate in the study.
Key exclusion criteria
Persons who refused to participate in the study. Persons deemed by the physician to be unsuitable for participation in the study.
Persons with allergies to scroll, sodium chloride, L(+) tartaric acid, quinine hydrochloride dihydrate or hydrochloric acid.
Persons who smoke.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Ebihara |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Internal Medicine and Rehabilitation Science
Zip code
980-8575
Address
Seiryo-machi 1-1, Aoba-ku Sendai
TEL
0227177353
satoru.ebihara.c4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Ebihara |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Internal Medicine and Rehabilitation Science
Zip code
980-8575
Address
Seiryo-machi 1-1, Aoba-ku Sendai
TEL
0227177353
Homepage URL
satoru.ebihara.c4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
Seiryo-machi 2-1, Aoba-ku, Sendai
Tel
0227178007
med-kenkyo@grp.tohoku.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
| 2023 | Year | 11 | Month | 10 | 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
| 2023 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | 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
| 2023 | Year | 11 | Month | 07 | Day |
Last modified on
| 2023 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060152
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
