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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name