UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010110 |
|---|---|
| Receipt number | R000011847 |
| Scientific Title | Investigation of new biomarkers for mood disorders |
| Date of disclosure of the study information | 2013/02/28 |
| Last modified on | 2022/09/02 13:20:37 |
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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
kkondo@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Oka |
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
naomiyon@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2589004220303722
Number of participants that the trial has enrolled
84
Results
The binding of SITH-1 to the host protein calcium-modu-lating ligand (CAML) to form an activated complex promoted the influx of extra-cellular calcium. The serum antibody titers for depressive patients with respect tothis activated complex were significantly higher than for normal controls (p =1.7831015), when the antibody positive rates were 79.8% and 24.4%, respec-tively, and the odds ratio was12.2. These results suggest that, in the latent phase,HHV-6B may be involved in the onset of depression.
Results date posted
| 2022 | Year | 03 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 06 | Month | 26 | Day |
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
| 2027 | Year | 02 | Month | 28 | 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
| 2022 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011847
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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