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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010110
Receipt No. R000011847
Scientific Title Investigation of new biomarkers for mood disorders
Date of disclosure of the study information 2013/02/28
Last modified on 2020/08/31

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Basic information
Public title Investigation of new biomarkers for mood disorders
Acronym Investigation of new biomarkers for mood disorders
Scientific Title Investigation of new biomarkers for mood disorders
Scientific Title:Acronym Investigation of new biomarkers for mood disorders
Region
Japan

Condition
Condition Mood disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate biological mechanisms with mood disorders by comparing those with mood disorders and healthy controls to determine new biomarkers.
Basic objectives2 Others
Basic objectives -Others Clinical characteristics
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Assessments of clinical depression symptoms, blood and saliva samples to compare those with mood disorders and healthy controls.
Key secondary outcomes

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with diagnoses of mood disorders, adjustment disorders, schizoaffective disorders and anxiety disorders in those age 16 and over, who are inpatients or outpatients, and healthy controls who volunteer to participate in the study after receiving an adequate explanation of the study.
Key exclusion criteria Severe physical illness
Target sample size 520

Research contact person
Name of lead principal investigator
1st name Kazuhiro
Middle name
Last name Kondo
Organization The Jikei University School of Medicine
Division name Department of Virology
Zip code 105-8461
Address 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL 03-3433-1111
Email kkondo@jikei.ac.jp

Public contact
Name of contact person
1st name Nobuyuki
Middle name
Last name Kobayashi
Organization The Jikei University School of Medicine
Division name Department of Virology
Zip code 105-8461
Address 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL 03-3433-1111
Homepage URL
Email kobayashi-n@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) Japan Tobacco inc.
Virus Ikagaku Kenkyusho Inc.

IRB Contact (For public release)
Organization Ethics Committee of the Jikei University School of Medicine
Address 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
Tel 03-3433-1111
Email rinri@jikei.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 東京慈恵会医科大学附属病院(東京都)、東京慈恵会医科大学附属柏病院(千葉県)、医療法人常心会川室記念病院(新潟県)、医療法人永光会あいらの森ホスピタル(旧栗野病院)(鹿児島県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 28 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 Enrolling by invitation
Date of protocol fixation
2013 Year 02 Month 25 Day
Date of IRB
2012 Year 12 Month 11 Day
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case control sampling

Management information
Registered date
2013 Year 02 Month 25 Day
Last modified on
2020 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011847

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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