UMIN-CTR Clinical Trial

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