UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049573 |
|---|---|
| Receipt number | R000056420 |
| Scientific Title | Research on Clinical Practice for Generalized Anxiety Disorder (GAD) Using the General Public as Subjects |
| Date of disclosure of the study information | 2022/11/21 |
| Last modified on | 2023/12/11 16:48:51 |
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Basic information
Public title
Research on Clinical Practice for Generalized Anxiety Disorder (GAD) Using the General Public as Subjects
Acronym
Research on Clinical Practice for Generalized Anxiety Disorder (GAD) Using the General Public as Subjects
Scientific Title
Research on Clinical Practice for Generalized Anxiety Disorder (GAD) Using the General Public as Subjects
Scientific Title:Acronym
Research on Clinical Practice for Generalized Anxiety Disorder (GAD) Using the General Public as Subjects
Region
| Japan |
Condition
Condition
Generalized anxiety disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To come up with an estimated morbidity rate (prevalence) of GAD, while gathering facts about QOL, behaviors related to visiting medical institutions and awareness of the disease among GAD patients.
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of patients of GAD-7 scores 10 or higher among the total population in this study.
Key secondary outcomes
1.EQ-5D-5L scores in the population of GAD-7 scores 10 or higher vs. the rest, and differences in such scores between the two populations.
2.Status of medical institution visitations in the population of GAD-7 scores 10 or higher.
3.Status of disease recognition in the population of GAD-7 scores 10 or higher.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Respondents must agree to participate in the research.
2.Respondents must be of age 18 or older at the time of expressing consent to participate in this study
Key exclusion criteria
There are no exclusion criteria for this study.
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Matsuyama |
Organization
Viatris Pharmaceuticals Japan Inc.
Division name
CNS, Medical Affairs
Zip code
105-0001
Address
Holland Hills Mori Tower, 5-11-2 Toranomon, Minato-ku, Tokyo
TEL
03-5656-0400
satoshi.matsuyama@viatris.com
Public contact
Name of contact person
| 1st name | Haruhiko |
| Middle name | |
| Last name | Seki |
Organization
INTAGE Healthcare
Division name
Marketing Insight Division Healthcare Research Department 1
Zip code
101-0062
Address
13F Ochanomizu SolaCity 4-6 Kanda-Surugadai Chiyoda-ku Tokyo
TEL
03-5295-1579
Homepage URL
haruhiko.seki@intage.com
Sponsor or person
Institute
Viatris Pharmaceuticals Japan Inc.
Institute
Department
Personal name
Funding Source
Organization
Viatris Pharmaceuticals Japan Inc.
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
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3,Kichijoji-kitamachi,Musashino-shi,Tokyo,180-001,Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.com
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
| 2022 | Year | 11 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Web Questionnaire Study
Management information
Registered date
| 2022 | Year | 11 | Month | 21 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056420
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
