UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter, cluster randomized controlled trial to investigate the effectiveness of the treatment guideline for major depressive disorder in Japan
Title of the study (Brief title)	A multicenter, cluster randomized controlled trial to investigate the effectiveness of the treatment guideline for major depressive disorder in Japan
Region	Japan

Condition
Condition	Major depressive disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Koichiro Watanabe
Organization	Kyorin University
Division name	Department of Neuropsychiatry, School of Medicine
Address	6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL	0422-47-5511
Email	koichiro@tke.att.ne.jp

Public contact
Name of contact person	Yoshikazu Takaesu
Organization	Kyorin University
Division name	Department of Neuropsychiatry, School of Medicine
Address	6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL	0422-47-5511
Homepage URL
Email	takaesu@ks.kyorin-u.ac.jp

Sponsor
Institute	Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2019 Year 01 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 10 Month 05 Day
Last modified on	2018 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038957