UMIN-ICDS Clinical Trial

Public title

THE SURVEY RESEARCH ON PRACTICE ISSUES OF MEASUREMENT-BASED CARE (MBC) IN THE TREATMENT OF DEPRESSION

Acronym

THE SURVEY ON PRACTICE ISSUES OF MBC IN THE TREATMENT OF DEPRESSION

Scientific Title

THE SURVEY RESEARCH ON PRACTICE ISSUES OF MEASUREMENT-BASED CARE (MBC) IN THE TREATMENT OF DEPRESSION

Scientific Title:Acronym

THE SURVEY ON PRACTICE ISSUES OF MBC IN THE TREATMENT OF DEPRESSION

Region

Japan

Condition

Major depressive disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to clarify Patients and clinicians implementing of the patient-rated rating scale and to identify challenges and barriers, facilitating factors, and countermeasures for implementing MBC from the perspectives of both patients and clinicians. Thereby, we hope to promote understanding of the significance and clinical usefulness of MBC and its dissemination.

Basic objectives2

Others

Basic objectives -Others

NA

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Tableluate the percentage and frequency of patients and psychiatrists for the following survey items.
-MBC Implementation Status
-Challenges of MBC implementation
-Acceptance of MBC and Facilitating Factors

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients;
-Physicians registered on the research panel used by Epoca Marketing Inc. at the start of the survey
-Patients with depression and informed by themselves
-Patients aged 18 years or older who are being treated
-Patients who have given written consent to the study

Physicians;
-Physicians registered on the research panel used by Epoca Marketing Inc. at the start of the survey
-Psycharists who have treated at least 10 patients with depression with ICD-10 or DSM-IV/DSM-5 in the last month at the start of the survey
-Physicians who have given written consent to this survey

Key exclusion criteria

Patients;
-Patients diagnosed with bipolar disorder by a physician, or those suspected of having bipolar disorder
-Patients diagnosed with schizophrenia by a physician

Phycisian;
-Physicians whose specialty is not psychiatry

Target sample size

1600

Name of lead principal investigator

1st name	Kenta
Middle name
Last name	Ikehara

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

Email

Ikehara.Kenta@otsuka.jp

Name of contact person

1st name	Kenta
Middle name
Last name	Ikehara

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

Email

Ikehara.Kenta@otsuka.jp

Institute

Otsuka Pharmaceutical Co., Ltd

Institute

Department

Personal name

Organization

Otsuka Pharmaceutical Co., Ltd

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kitamachi Shinryojo Ethics Review Board

Address

1-1-3,KichijojiKitamachi,Musashino-si.Tokyo

Tel

03-6779-8116

Email

chi-pr-ec-kitamachi@cmicgroup.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

02

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2025

Year

10

Month

24

Day

Date of IRB

2025

Year

11

Month

19

Day

Anticipated trial start date

2026

Year

01

Month

13

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The purpose of this cross-sectional observational study is to confirm perspective from patient on a self-rating scale in Japan and to identify challenges and barriers, facilitating factors, and countermeasures for implementing MBC from the perspectives of both patients and clinicians. Thereby, we hope to promote understanding of the significance and clinical utility of MBC and its dissemination.

We will collect responses from patients and physicians on items related to MBC implementation status, challenges in implementing MBC, acceptance of MBC, and facilitating factors, and summarize the proportions and frequencies for each item using descriptive statistics.

Registered date

2026

Year

02

Month

17

Day

Last modified on

2026

Year

02

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068930