UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	salivary biomarkers for depression
Title of the study (Brief title)	salivary biomarkers for depression
Region	Japan

Condition
Condition	depressive disorder
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to found the association the depressed state and saliva cytokine consentration.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Using HAM-D, MADRS, QIDS-SR-J, we score a depression symptom and evaluate association with cytokine density in saliva.
Key secondary outcomes	Checking psychological stress(K10), the sleep situation(Athens sleeplessness standard)and a personality test(TCI)as well as a depression symptom.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Only one time of approximately 1 ml of blood.
Interventions/Control_2	Only one time of approximately 1 ml of saliva by subject oneself.
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	The adult that the criteria for selection of the depression group meet diagnostic criteria of the depression. The adult that the criteria for selection of the control group have not received a diagnosis of past depression and are less than six points in less than seven points or QIDS-SR-J in HAM-D.
Key exclusion criteria	1.Affected with inflammatory diseases, endocrine diseases, metabolic diseases and severe periodontal diseases. 2.Taken antiallergic drugs, steroid, or immunosuppressive drugs within one month. 3.Affected some brain tissue characteristics obstacles. 4.The past of psychogenic mental disorderd except the depression or endogenous mental disorders and organic mental disorder.
Target sample size	200

Research contact person
Name of lead principal investigator	Sumie Yui
Organization	Shinshu University School of Medicine
Division name	Department of Psychiatry
Address	3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL	0263-37-2638
Email	yuis@shinshu-u.ac.jp

Public contact
Name of contact person	Sumie Yui
Organization	Shinshu University School of Medicine
Division name	Department of Psychiatry
Address	3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL	0263-37-2638
Homepage URL
Email	yuis@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	JAPAN TOBACCO INC.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 11 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 02 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 25 Day
Last modified on	2017 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033913