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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020498
Receipt No. R000023667
Scientific Title Utility of Keio Shared Decision Making (K-SDM) program for depression: an interventional study
Date of disclosure of the study information 2016/01/12
Last modified on 2016/01/08

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Basic information
Public title Utility of Keio Shared Decision Making (K-SDM) program for depression: an interventional study
Acronym Utility of Keio Shared Decision Making (K-SDM) program for depression: an interventional study
Scientific Title Utility of Keio Shared Decision Making (K-SDM) program for depression: an interventional study
Scientific Title:Acronym Utility of Keio Shared Decision Making (K-SDM) program for depression: an interventional study
Region
Japan

Condition
Condition Major Depressive Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine effects of K-SDM program on treatment outcomes and adherence in patients with major depressive disorders.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) Medication Possession Ratio (MPR) at 6 months after discharge
2) Remission rate (i.e. a score of <5 in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR)) at 6 months after discharge
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Patients with major depressive disorder will receive the K-SDM program for adherence.

Interventions/Control_2 Patients with major depressive disorder will receive the usual medication counselling.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Diagnosis of major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5)
2) 20 years or older of age
Key exclusion criteria 1) Presence of severe suicide ideation
2) Presence of any unstable physical illness
3) Presence of severe cognitive dysfunction (i.e. a score of <20 in the Mini-Mental State Examination)
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Uchida
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-5363-3971
Email hiroyuki.uchida.hu@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Jinichi HIrano
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-5363-3971
Homepage URL
Email hjinichi@gmail.com

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Department of Neuropsychiatry, Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 12 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
2016 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 12 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
2016 Year 01 Month 08 Day
Last modified on
2016 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023667

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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