UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054220 |
|---|---|
| Receipt number | R000061868 |
| Scientific Title | The fact-finding survey on Shared Decision Making(SDM)/Measurement Based Care(MBC)in the treatment of depression |
| Date of disclosure of the study information | 2024/04/26 |
| Last modified on | 2025/11/11 09:15:13 |
* 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
The fact-finding survey on Shared Decision Making(SDM)/Measurement Based Care(MBC)in the treatment of depression
Acronym
The survey on SDM/MBC in the treatment of depression
Scientific Title
The fact-finding survey on Shared Decision Making(SDM)/Measurement Based Care(MBC)in the treatment of depression
Scientific Title:Acronym
The survey on SDM/MBC in the treatment of depression
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identify gaps in understanding and perceptions of depression and depression treatment between psychiatrists and patients by investigating the following realities
1. current status and concept of SDM/MBC
2. patient needs for SDM/MBC and gaps in understanding and perception between psychiatrists and patients
3. challenges due to lack of implementation of SDM/MBC
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Tabulation of each answer
2. Tabulation of the following items
Cross-tabulation of SDM/MBC implementation and responses of physicians and patients to the following items (content and comprehension of explanations regarding depression treatment, content and comprehension of explanations regarding antidepressants, treatment satisfaction, communication status, comprehension and satisfaction, SDM implementation status and needs, and rating scale use status and needs, etc.)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All of the following conditions must be met
Phycisian;
Physicians registered on the Epoca Marketing Inc. research panel at the start of the survey
Physicians who have treated at least 10 patients with depression in the last month
Physicians who have given written consent to this survey
Patients;
Patients with an ICD-10 or DSM-IV/DSM-5 diagnosis of depression and informed by their own physicians
Patients aged 18 years or older who are being treated with antidepressant medication
Patients who have given written consent to the study
Key exclusion criteria
N/A
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Sekine |
Organization
Otsuka Phamacetutical Co., Ltd
Division name
Department of Medical Affairs
Zip code
1088242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo
TEL
03-6717-1400
sekined@otsuka.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Aoki |
Organization
Otsuka Phamacetutical Co., Ltd
Division name
Department of Medical Affairs
Zip code
1088242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo
TEL
03-6717-1400
Homepage URL
aoki.kazuo@otsuka.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Research Ethics Committee, Research Division, Otsuka Pharmaceutical Co., Ltd
Address
463-10 Kagasuno, Kawauchi-cho, Tokushima City, Tokushima
Tel
088-665-2126
Suzuki.Takashi@otsuka.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
445
Results
Subjects analyzed: 67 psychiatrists, 445 patients
Implementation Status of Measurement-Based Care
MBC Implementation Rate: 13.1% (58/443 pairs)
Implementation Rate Reported by Psychiatrists: 28.0% (124/443 pairs)
Implementation Status of Shared Decision Making
Implementation rate: 12.6% (56/444 pairs)
Implementation rate reported by psychiatrists: 30.6% (136/444 pairs)
Results date posted
| 2025 | Year | 11 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patient characteristics
Average patient age: 45.3 years, 53.9% female
Depression severity (7-point Likert scale): Average 4.6
Psychiatrist assessment: Mild 44.0%, Moderate 47.9%, Normal 2.2%
Median disease duration: 44 months (16.5% <1 year, 26.4% 1-3 years)
Physician Characteristics
Age Group: 40s 34.3%, 50s 34.3%
Clinical Experience: Average 20.5 years
Participant flow
NA
Adverse events
NA
Outcome measures
Implementation Status of Measurement-Based Care
Perception Gap Between Patients and Physicians Regarding MBC
Implementation Status of Shared Decision Making
Perception Gap Between Patients and Physicians Regarding SDM
Patient Clinical Needs (7-point Likert scale)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To identify gaps in understanding and perceptions of depression and depression treatment between physicians and patients, primarily by studying the reality of SDM/MBC in the treatment of depression
Management information
Registered date
| 2024 | Year | 04 | Month | 22 | Day |
Last modified on
| 2025 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061868
