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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025307
Receipt No. R000028386
Scientific Title Identification of biomarkers for diagnosis of major depression
Date of disclosure of the study information 2017/01/01
Last modified on 2019/06/20

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Basic information
Public title Identification of biomarkers for diagnosis of major depression
Acronym Identification of biomarkers of depression
Scientific Title Identification of biomarkers for diagnosis of major depression
Scientific Title:Acronym Identification of biomarkers of depression
Region
Japan

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

Objectives
Narrative objectives1 Examining the effect of exercise therapy on depression and salivary levels of cortisol, alpha-amylase, and cytokines.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hamilton depression rating scale, Montgomery-Asberg Depression Rating Scale, and salivary levels of cortisol, alpha-amylase, and cytokines.
Key secondary outcomes

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 Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Eight weeks of exercise therapy
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 Major depression group:
Adults diagnosed as major depressive disorder

Control group:
Adults not diagnosed as major depressive disorder
Key exclusion criteria 1. Suffers from any inflammatory, endocrine, or metabolic disorders or suffers from severe periodontal disease.
2. Has taken anti-allergic medication, steroid, or immunosuppressant medication in the past month.
3. Suffers from organic brain disease.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Daimei
Middle name
Last name Sasayama
Organization Shinshu University School of Medicine
Division name Department of Psychiatry
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto
TEL 0263372638
Email sasayama@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Daimei
Middle name
Last name Sasayama
Organization Shinshu University School of Medicine
Division name Department of Psychiatry
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto
TEL 0263372638
Homepage URL
Email sasayama@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Shinshu University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Shinshu University School of Medicine Medical Ethics Committee
Address 3-1-1 Asahi, Matsumoto
Tel 0263-37-2572
Email mdrinri@shinshu-u.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

Other administrative information
Date of disclosure of the study information
2017 Year 01 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
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
2016 Year 12 Month 06 Day
Date of IRB
2016 Year 12 Month 06 Day
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
2021 Year 03 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
2016 Year 12 Month 17 Day
Last modified on
2019 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028386

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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