UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057689 |
|---|---|
| Receipt number | R000065830 |
| Scientific Title | Questionnaire study in Japanese patients with generalized anxiety disorder (GAD) |
| Date of disclosure of the study information | 2025/04/23 |
| Last modified on | 2025/04/23 08:12:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Questionnaire study in Japanese patients with generalized anxiety disorder (GAD)
Acronym
Questionnaire study in Japanese patients with generalized anxiety disorder (GAD)
Scientific Title
Questionnaire study in Japanese patients with generalized anxiety disorder (GAD)
Scientific Title:Acronym
Questionnaire study in Japanese patients with generalized anxiety disorder (GAD)
Region
| Japan |
Condition
Condition
Generalized anxiety disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate patients with GAD (who have participated in a clinical trial) on their experiences and circumstances leading to clinical trial participation, awareness of GAD, medical care-seeking behavior, medical consultation, diagnosis, treatment, as well as their treatment satisfaction and physical and mental health, behavior, and challenges at each stage of subsequent course of disease. Gaining insight into the patients' real experiences through this survey will aid in creating an environment where patients can receive appropriate diagnosis and treatment.
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Endpoint 1: Awareness of GAD and medical care-seeking behavior until diagnosis
Endpoint 2: Symptoms of GAD at trial entry
Endpoint 3: Visits to the clinical trial site and diagnosis
Endpoint 4: Situation from after the end of the clinical trial to the present
Endpoint 5: Efforts needed to promote disease awareness
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
Patients with GAD (diagnosed according to DSM-5) who participated in "A placebo-controlled, randomized, double-blind, multicenter study to evaluate the efficacy and safety of venlafaxine in Japanese outpatients with generalized anxiety disorder (Study B2411367)" via a clinical trial information website and meet the following criteria will be included in analyses.
1.Voluntarily consented to participate in this study by electronic means
Key exclusion criteria
None
Target sample size
219
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Nomoto |
Organization
Viatris Pharmaceuticals Japan G.K.
Division name
Medical Affairs
Zip code
106-0041
Address
1-3-1, Azabudai, Minato-ku, Tokyo
TEL
03-5656-0400
Keisuke.Nomoto@viatris.com
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Sato |
Organization
3H Medi Solution Inc.
Division name
Patient Recruitment Group
Zip code
171-0022
Address
JRE Minami-Ikebukuro Bleg.2F, 1-13-23 Minami-Ikebukuro, Toshima-ku, Tokyo, Japan
TEL
03-5953-2108
Homepage URL
info@c-trial.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
| 2025 | Year | 04 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 25 | 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
| 2025 | Year | 04 | Month | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065830
