UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005728 |
|---|---|
| Receipt number | R000006771 |
| Scientific Title | Association of Japanese-specific anxiety related traits with a polymorphism in the serotonin transporter gene in physical activity and sport: open-label, non-randomaized, single group assignment, time series designed trial. |
| Date of disclosure of the study information | 2011/06/06 |
| Last modified on | 2023/06/15 09:33:18 |
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Basic information
Public title
Association of Japanese-specific anxiety related traits with a polymorphism in the serotonin transporter gene in physical activity and sport: open-label, non-randomaized, single group assignment, time series designed trial.
Acronym
Association of Japanese-specific anxiety related traits with a polymorphism in the serotonin transporter gene.
Scientific Title
Association of Japanese-specific anxiety related traits with a polymorphism in the serotonin transporter gene in physical activity and sport: open-label, non-randomaized, single group assignment, time series designed trial.
Scientific Title:Acronym
Association of Japanese-specific anxiety related traits with a polymorphism in the serotonin transporter gene.
Region
| Japan |
Condition
Condition
Healthy general population in physical activity and sport.
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the effects of the serotonin transporter polymorphism associated with the stressful events under pressure and risk of depression in physical activity and sport.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Polymorphism in the serotonin transporter gene
2)Other genetic polymorphisms involved in emotion (comprehensively research)
Key secondary outcomes
2)State and Trait Anxiety Inventory(STAI)
3)Profile of Mood scale(BRUMS)
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
Educational,Counseling,Training
Type of intervention
| Gene | Behavior,custom |
Interventions/Control_1
We research psychological questionnaires of participants at the normal exercise day and the stressful events under pressure day. After that, we investigated thier types of serotonin transporter gene.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy population in physical activity and sport.
2) Adults over 20 years of age, when we gather the mucous membrane in the mouth for DNA.
Key exclusion criteria
1)Person without medical history such as bronchial asthma, diabetes, heart troubles, the thyreoid disease.
2)Person that it was stopped participation by a doctor.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kanaka |
| Middle name | |
| Last name | Yatabe |
Organization
St. Marianna University School of Medicine
Division name
Department of Sports Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL
+81-44-977-8111
kanaka@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kanaka |
| Middle name | |
| Last name | Yatabe |
Organization
St. Marianna University School of Medicine
Division name
Department of Sports Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL
+81-44-977-8111
Homepage URL
kanaka@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research from Ministry of Education, Culture, Sports, Science and Technology (MEXT) in Japan.
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
St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki
Tel
0449778111
kanaka@marianna-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
聖マリアンナ医科大学スポーツ医学講座（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 06 | 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
45
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2030 | 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
| 2011 | Year | 06 | Month | 06 | Day |
Last modified on
| 2023 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006771
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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