UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020498 |
|---|---|
| Receipt number | 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 | 2021/07/13 11:15:53 |
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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
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
hjinichi@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
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
| 2021 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023667
