UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063234 |
|---|---|
| Receipt number | R000072360 |
| Scientific Title | Real-World Clinical Practice of Generalized Anxiety Disorder (GAD) Among Physicians |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2026/10/09 10:08:36 |
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Basic information
Public title
Real-World Clinical Practice of Generalized Anxiety Disorder (GAD) Among Physicians
Acronym
Real-World Clinical Practice of Generalized Anxiety Disorder (GAD) Among Physicians
Scientific Title
Real-World Clinical Practice of Generalized Anxiety Disorder (GAD) Among Physicians
Scientific Title:Acronym
Real-World Clinical Practice of Generalized Anxiety Disorder (GAD) Among Physicians
Region
| Japan |
Condition
Condition
Generalized anxiety disorder
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the current status of the diagnosis and treatment of generalized anxiety disorder (GAD) among psychiatrists and psychosomatic medicine physicians in Japan, and to clarify changes in physicians' awareness and clinical practice since the previous survey conducted in December 2022. This study also aims to identify unmet needs in GAD treatment that remain after the approval of an additional indication for GAD.
Basic objectives2
Others
Basic objectives -Others
Descriptive assessment of disease awareness, diagnostic and treatment practices, and unmet needs regarding GAD among psychiatrists and psychosomatic medicine physicians
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All items in the web-based questionnaire, including: awareness of GAD; number of patients diagnosed with GAD and diagnostic methods (use of operational diagnostic criteria, DSM-5-TR, and patient self-rating scales); prescribing practices (first- and second-line agents, reasons for selection, and prescribing patterns); non-pharmacological treatments, including psychosocial therapies; changes in unmet diagnostic and treatment needs before and after the approval of an additional indication for GAD; overall satisfaction with GAD treatment; collaboration with non-specialists; and perceived need for disease awareness activities for physicians and the general public.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Provide informed consent to participate in the study on the web.
2.Main clinical department is psychiatry or psychosomatic medicine.
3.Physicians who have treated 10 or more outpatients or 10 or more inpatients in the past month.
Key exclusion criteria
None
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Misato |
| Middle name | |
| Last name | Kitamura |
Organization
Viatris Pharmaceuticals Japan G.K.
Division name
Psychiatry, Medical Affairs
Zip code
106-0041
Address
Azabudai Hills Mori JP Tower, 1-3-1 Azabudai, Minato-ku, Tokyo, Japan
TEL
03-5656-0400
Misato.Kitamura@viatris.com
Public contact
Name of contact person
| 1st name | Tetsuri |
| Middle name | |
| Last name | Suzuki |
Organization
INTAGE Healthcare Inc.
Division name
HEOR Group 1, Healthcare Research Department 1, Marketing & Value Insight Division
Zip code
101-0062
Address
13F Ochanomizu SolaCity, 4-6 Kanda-Surugadai Chiyoda-ku, Tokyo 101-0062
TEL
03-5294-8393
Homepage URL
suzuki.49352@intage.com
Sponsor or person
Institute
Viatris Pharmaceuticals Japan G.K.
Institute
Department
Personal name
Funding Source
Organization
Viatris Pharmaceuticals Japan G.K.
Organization
Division
Category of Funding Organization
Profit organization
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, 180-0001, 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
| 2026 | Year | 10 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 28 | Day |
Date of closure to data entry
| 2026 | Year | 10 | Month | 28 | Day |
Date trial data considered complete
| 2026 | Year | 11 | Month | 09 | Day |
Date analysis concluded
| 2026 | Year | 11 | Month | 30 | Day |
Other
Other related information
[Study design] Cross-sectional observational study using a web-based questionnaire (non-interventional, non-invasive).
[Participants] Physicians whose main clinical department is psychiatry or psychosomatic medicine, randomly selected from the physician panel of PLAMED Inc. and meeting the inclusion criteria.
[Sample size] A sample of 400 is required to keep the half-width of the 95% confidence interval for proportions at 5% or less; the target was set at 500 to allow for invalid responses.
[Statistical analysis] Categorical variables will be summarized as numbers and percentages, and continuous variables as summary statistics (n, mean, standard deviation, minimum, median, and maximum). Results for items common to the December 2022 physician survey (Nomoto K, et al. Neuropsychiatr Dis Treat. 2024;20:1001-1010) will be presented side by side and compared descriptively.
Management information
Registered date
| 2026 | Year | 10 | Month | 09 | Day |
Last modified on
| 2026 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072360
