UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059548 |
|---|---|
| Receipt number | R000068111 |
| Scientific Title | The Prevalence of Probable Generalized Anxiety Disorder in General Internal Medicine Clinics: A multicenter, cross-sectional study in Japan |
| Date of disclosure of the study information | 2025/10/31 |
| Last modified on | 2025/10/27 12:29:24 |
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Basic information
Public title
The Prevalence of Probable Generalized Anxiety Disorder in General Internal Medicine Clinics: A multicenter, cross-sectional study in Japan
Acronym
The Prevalence of Probable Generalized Anxiety Disorder in General Internal Medicine Clinics
Scientific Title
The Prevalence of Probable Generalized Anxiety Disorder in General Internal Medicine Clinics: A multicenter, cross-sectional study in Japan
Scientific Title:Acronym
G-PRIME Study
Region
| Japan |
Condition
Condition
Generalized Anxiety Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the extent to which patients with probable GAD are present in general internal medicine clinics, excluding psychiatry and psychosomatic medicine.
Basic objectives2
Others
Basic objectives -Others
Prevalence of GAD
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Estimated overall prevalence of probable GAD (GAD-7 score => 10) in general internal medicine clinics.
Key secondary outcomes
1) Estimated prevalence of probable GAD according to sex, age, primary diagnosis, cohabiting family status, marital status and years of education.
2) EQ-5D-5L, PHQ-9 and AIS scores in the probable GAD and non-GAD groups.
3) Comparison of EQ-5D-5L and AIS scores across four groups defined by GAD-7 and PHQ-9 scores:
Group1: probable GAD only (GAD-7 score => 10, PHQ-9 score < 10)
Group2: probable major depressive disorder (MDD) only (GAD-7 score < 10, PHQ-9 score => 10)
Group3: comorbid probable GAD and MDD (GAD-7 score => 10, PHQ-9 score => 10)
Group4: neither probable GAD nor MDD (GAD-7 score < 10, PHQ-9 score < 10
4) Primary diagnoses and treatment details (types/generic name of prescribed psychotropic medications and other medications that may be used in the treatment of psychiatric disorders, generic names of Kampo medications used for psychiatric symptoms) in the probable GAD and non-GAD groups.
5) Correlation between GAD-7 scores and other symptom scales (PHQ-9 and AIS).
6) Distribution of GAD-7 severity categories: mild (5-9), moderate (10-14), and severe (15-21)
7) Identification of factors associated with probable GAD using logistic regression analysis.
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. Japanese male or female participants who are over 18 years of age or older at the time of obtaining informed consent
2. Outpatients in general internal medicine clinic
3. Outpatients visiting the internal medicine clinic regularly (at least once every 3 months) due to their diseases
4. Patients able to sign informed consent 5. Patients who are willing to participate in this study and answer the questionnaire
Key exclusion criteria
1. Patients visiting a psychiatry or psychosomatic medicine due to their mental disorders
2. Patients with a prior or current diagnosis of dementia
3. Patients visiting a clinic unexpectedly due to only acute symptoms such as fever
4. Patients who are deemed inappropriate for participation in this study by the investigators
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Matsuyama |
Organization
Viatris Pharmaceuticals Japan G.K.
Division name
Medical Affairs
Zip code
106-0041
Address
Azabudai Hills Mori JP Tower, 1-3-1 Azabudai, Minato-ku, Tokyo 106-0041, Japan
TEL
03-5656-0400
Satoshi.Matsuyama@viatris.com
Public contact
Name of contact person
| 1st name | Karen |
| Middle name | |
| Last name | Ishikawa |
Organization
Mebix, Inc.
Division name
Research Promotion Division
Zip code
105-0001
Address
10th Floor, Toranomon 33 Mori Building, 3-8-21 Toranomon, Minato-ku, Tokyo 105-0001, Japan
TEL
03-4362-4504
Homepage URL
GAD-screening@mebix.co.jp
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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihonbashi Sakura Clinic Ethics Committee, Medical Corporation Ouryokukai
Address
5th Floor, Inamura Building, 1-9-2 Kayabacho, Nihonbashi, Chuo-ku, Tokyo, Japan
Tel
03-6777-1490
c-irb_ug@neues.co.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
医療法人HSR 名嘉村クリニック（沖縄県）、医療法人社団 寺田内科・呼吸器科（兵庫県）、医療法人翔誠会 ふくだ内科（埼玉県）、医療法人名甲会 おなか内科東白壁クリニック（愛知県）、医療法人緑風会 みどりクリニック（長崎県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 31 | 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
| 2025 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to visualize how patients with probable GAD are currently being diagnosed and treated in general practice settings using a questionnaire-based survey of all patients who meet the inclusion criteria and regularly visit a general medical clinic to determine the estimated prevalence of GAD.
EuroQOL 5 Dimensions 5-Level (EQ-5D-5L)
Patient Health Questionnaire-9 (PHQ-9)
Athens Insomnia Scale (AIS)
Management information
Registered date
| 2025 | Year | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068111
