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The Prevalence of Probable Generalized Anxiety Disorder in General Internal Medicine Clinics: A multicenter, cross-sectional study in Japan

The Prevalence of Probable Generalized Anxiety Disorder in General Internal Medicine Clinics: A multicenter, cross-sectional study in Japan - G-PRIME Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000059548
Enrollment
500
Registered
2025-10-31
Start date
2025-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder

Interventions

None listed

Sponsors

Viatris Pharmaceuticals Japan G.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Estimated overall prevalence of probable GAD (GAD-7 score => 10) in general internal medicine clinics.

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactKaren Ishikawa

Mebix, Inc. Research Promotion Division

GAD-screening@mebix.co.jp03-4362-4504

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026