UMIN-CTR Clinical Trial

Public title

A multicenter, cluster randomized controlled trial to investigate the effectiveness of the treatment guideline for major depressive disorder in Japan

Acronym

A multicenter, cluster randomized controlled trial to investigate the effectiveness of the treatment guideline for major depressive disorder in Japan

Scientific Title

A multicenter, cluster randomized controlled trial to investigate the effectiveness of the treatment guideline for major depressive disorder in Japan

Scientific Title:Acronym

A multicenter, cluster randomized controlled trial to investigate the effectiveness of the treatment guideline for major depressive disorder in Japan

Region

Japan

Condition

Major depressive disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine the effectiveness of an intervention program composed of two components (i.e., lectures and practical applications) on psychiatrists. The lectures cover the guideline-recommended treatments for depression. The practical applications involve increasing patient participation in shared decision making.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

The primary outcome is the shared decision making scores at baseline, 4 weeks, and 12 weeks after enrollment in the study.

Key secondary outcomes

1) Client Satisfaction Questionnaire (CSQ-8-J) scores at baseline, 4 weeks, and 12 weeks
2) EuroQol 5 Dimension (EQ-5D) scores at baseline, 4 weeks, and 12 weeks
3) Trust in Physician Scale (TPS) scores at baseline, 4 weeks, and 12 weeks
4) Quick Inventory of Depressive Symptomatology (QIDS-J) scores at baseline, 4 weeks, and 12 weeks

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

The intervention will be carried out in one-day workshop. The training program consists of lectures (treatment guideline for major depressive disorder) and group education (social function, QOL, and shared decision making).

Interventions/Control_2

The control group will be under the "treatment as usual" (TAU) condition without the intervention.

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

20

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients who meet the criteria for major depressive disorder according to DSM-5 and who are able to provide written informed consent.

Key exclusion criteria

1) Severe depressive symptoms that require hospitalization
2) Having urgent suicidal ideation
3) Severe physical illness
4) Having dementia
5) Ongoing alcohol or substance abuse
6) Disturbance of consciousness

Target sample size

204

Name of lead principal investigator

1st name
Middle name
Last name	Koichiro Watanabe

Organization

Kyorin University

Division name

Department of Neuropsychiatry, School of Medicine

Zip code

Address

6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan

TEL

0422-47-5511

Email

koichiro@tke.att.ne.jp

Name of contact person

1st name
Middle name
Last name	Yoshikazu Takaesu

Organization

Kyorin University

Division name

Department of Neuropsychiatry, School of Medicine

Zip code

Address

6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan

TEL

0422-47-5511

Homepage URL

Email

takaesu@ks.kyorin-u.ac.jp

Institute

Japan Agency for Medical Research and Development

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2019

Year

01

Month

01

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

2018

Year

09

Month

01

Day

Date of IRB

Anticipated trial start date

2018

Year

09

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

10

Month

05

Day

Last modified on

2018

Year

09

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038957