UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061553 |
|---|---|
| Receipt number | R000070307 |
| Scientific Title | A Survey of Clinical Practice for Major Depressive Disorder with Anxious Distress |
| Date of disclosure of the study information | 2026/05/13 |
| Last modified on | 2026/05/13 14:53:17 |
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Basic information
Public title
A Survey of Clinical Practice for Major Depressive Disorder with Anxious Distress
Acronym
A Survey of Clinical Practice for Major Depressive Disorder with Anxious Distress
Scientific Title
A Survey of Clinical Practice for Major Depressive Disorder with Anxious Distress
Scientific Title:Acronym
A Survey of Clinical Practice for Major Depressive Disorder with Anxious Distress
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate clinical practice among psychiatrists in Japan by quantifying the frequency and percentage of awareness of the DSM-5-TR specifier with anxious distress, diagnostic status and its reasons, and treatment choices for depression with anxious distress.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Responses will be collected for the following survey items, and frequency and percentage will be tabulated
-Awareness of depression with anxious distress
-Whether a diagnosis of depression with anxious distress is make and the reasons for the diagnostic decision
-Treatment choices for depression with anxious distress
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
-Physicians affiliated with medical institutions that provide psychiatric services.
-Psychiatrists who consented to participate in the survey.
-Psychiatrists who have treated more than 10 outpatients with depression in the month prior to providing informed consent.
Key exclusion criteria
N/A
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Mizukoshi |
Organization
Otsuka Pharmaceutical Co., Ltd
Division name
Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo
TEL
03-6717-1400
Mizukoshi.Shota@otsuka.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Mizukoshi |
Organization
Otsuka Pharmaceutical Co., Ltd
Division name
Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo
TEL
03-6717-1400
Homepage URL
Mizukoshi.Shota@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd
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
Kitamachi Shinryojo Ethics Review Board
Address
1-1-3,Kichijoji-kitamachi,Musashino-shi,Tokyo
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 | 05 | Month | 13 | 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 | 03 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a Descriptive research using questionnaire survey conducted in compliance with relevant laws and regulations, including the Declaration of Helsinki of the World Medical Association and the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects.
The participants were provided with a written explanation of informed consent, including appropriate information regarding the use of data in this study, and their consent to participate was obtained prior to survey participation.
Management information
Registered date
| 2026 | Year | 05 | Month | 13 | Day |
Last modified on
| 2026 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070307
