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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034397
Receipt No. R000038957
Scientific Title A multicenter, cluster randomized controlled trial to investigate the effectiveness of the treatment guideline for major depressive disorder in Japan
Date of disclosure of the study information 2019/01/01
Last modified on 2018/09/27

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Basic information
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
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
Last 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

Public contact
1st 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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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