UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044001 |
|---|---|
| Receipt number | R000050092 |
| Scientific Title | Relationship between depressive patients with physical illness and nutrition -Cross sectional study- |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2021/04/21 15:58:35 |
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Basic information
Public title
Relationship between depressive patients
with physical illness and nutrition
-Cross sectional study-
Acronym
Relationship between depressive patients
with physical illness and nutrition
Scientific Title
Relationship between depressive patients
with physical illness and nutrition
-Cross sectional study-
Scientific Title:Acronym
Relationship between depressive patients
with physical illness and nutrition
-Cross sectional study-
Region
| Japan |
Condition
Condition
depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between depressive symptoms and nutritional status in patients with physical disease.
Basic objectives2
Others
Basic objectives -Others
cross sectional study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Score of the Center for Epidemiology Studies Depression scale (CES-D)
Key secondary outcomes
- Subjective Global Assessment
- Height, Body weight, Body Mass Index and weight loss rate, triceps brachii subcutaneous fat thickness, brachial muscle circumference and brachial muscle area
- Blood test (in addition to general biochemical test, EPA, DHA, vitamin B group, folic acid, tryptophan, homocysteine, ferritin, Fe, Zn, Ca, I, Mg, Cu, Se)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age 20 years old or more persons
2) A person who has received sufficient explanation in participating in this research and obtained written consent at his / her own free will
Key exclusion criteria
1) Those who have consciousness disturbance or severe dementia
2) Those who have difficulty in evaluating depression through questionnaires and interviews due to serious physical illness, etc.
3) Persons with psychiatric disorders other than schizophrenia and depression
4) Others who are judged to be inappropriate by the principal investigator or coordinator
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Yamamoto |
Organization
Tokai University
Division name
School of Medicine, Department of Psychiatry
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa, 259-1193 Japan
TEL
+81463931121
key@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Yamamoto |
Organization
Tokai University
Division name
School of Medicine, Department of Psychiatry
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa, 259-1193 Japan
TEL
+81463931121
Homepage URL
key@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine, Department of Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutinal Revew Borad for Clinical Research, Tokai University
Address
143 Shimokasuya, Isehara, Kanagawa, 259-1193 Japan
Tel
+81463931121
tokai-rinsho@ml.tokai-u.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
東海大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 01 | 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
112
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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study (cross-sectional study), and the subjects were patients who visited our institution from October 2016 to September 2020 and who met the selection criteria and obtained consent for the study.
Management information
Registered date
| 2021 | Year | 04 | Month | 21 | Day |
Last modified on
| 2021 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050092
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
