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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044001
Receipt No. 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

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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
Email 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
Email key@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine, Department of Psychiatry
Institute
Department

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
Email 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
URL(English) https://upload.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


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