UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053261 |
|---|---|
| Receipt number | R000060788 |
| Scientific Title | Investigation of the relationship between taste and depression/anxiety in psychosomatic day care patients. |
| Date of disclosure of the study information | 2024/01/04 |
| Last modified on | 2024/01/04 09:59:42 |
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Basic information
Public title
Investigation of the relationship between taste and depression/anxiety in psychosomatic day care patients.
Acronym
Investigation of the relationship between taste and depression/anxiety
Scientific Title
Investigation of the relationship between taste and depression/anxiety in psychosomatic day care patients.
Scientific Title:Acronym
Investigation of the relationship between taste and depression/anxiety
Region
| Japan |
Condition
Condition
Psychiatric Day Care Patients
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between mood, such as anxiety and depression, and taste in psychiatric outpatients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
salt taste threshold using SALSAVE
Key secondary outcomes
Five Viscera Score
Salivary amylase levels
Hospital-anxiety depression scale
Self-rating depression scale
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Measuring salt taste thresholds with the SALSAVE
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
I. Be male or female, 18 years of age or older
II. Able to obtain informed consent in writing
Key exclusion criteria
I. Pregnant or lactating
II. are undergoing treatment for anemia
III. smoking
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Sumire |
| Middle name | |
| Last name | Ishiyama |
Organization
Ibaraki Prefectural university of health sciences.
Division name
Center of medical sciences
Zip code
3000394
Address
4669-2, Ami-machi, Ami, Ibaraki, Japan
TEL
0298884000
ishiyamasu@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Sumire |
| Middle name | |
| Last name | Ishiyama |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Center of Medical Sciences
Zip code
3000394
Address
4669-2, Ami-machi, Ami, Ibaraki, Japan
TEL
02998884000
Homepage URL
ishiyamasu@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Prefectural University of Health Sciences
Address
4669-2, Ami-machi, Ami, Ibaraki, Japan
Tel
0298884000
ishiyamasu@ipu.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
つくば心療内科クリニック、水戸メンタルクリニック
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 01 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060788
| Research Plan | |
|---|---|
| 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 |
