UMIN-ICDS Clinical Trial

Public title

The clinical feasibility of a system for optimizing depression treatment

Acronym

The feasibility of a system for optimizing depression treatment

Scientific Title

The clinical feasibility of a system for optimizing depression treatment through integration of medical information: a prospective cohort study

Scientific Title:Acronym

The feasibility of a system for optimizing depression treatment

Region

Japan

Condition

depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

A prospective cohort study will be conducted to examine the feasibility of the depression treatment optimization tool, which integrates remission prediction and ongoing treatment support, to evaluate its potential for sustained use in clinical practice.

Basic objectives2

Others

Basic objectives -Others

In the future, it will be necessary to verify whether the use of depression treatment optimization tools is truly useful, but as a preliminary step, there is a lack of basic information on the extent to which such treatment support tools can be used in clinical practice, and to what extent they can be used continuously.Therefore, a prospective cohort study will be conducted to examine the feasibility of the depression treatment optimization tool, which integrates remission prediction and ongoing treatment support, to evaluate its potential for sustained use in clinical practice.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Physicians' difficulty and 3-month retention rate in using the tool

Key secondary outcomes

For physicians: compliance with the recommended treatment during the 3-month period, expected number of subjects who will use the tool, and contribution to treatment selection. For patients: degree of difficulty in reporting symptoms and of satisfaction with treatment

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Research Physician:
All of the following must be met
(1) Physicians at medical institutions that specialize in psychiatry
(ii) A person who understands the purpose and content of the study and has obtained written consent from the individual to participate in the study of his/her own free will.

Patients to be studied:
Patients who meet all of the following criteria
(1) Patients who recognize the diagnostic criteria for depression in DSM-5.
(ii) 18 years of age or older at the time consent is obtained
(iii) Patients who understand the purpose and content of the study and have given their written consent to participate in the study of their own free will.

Key exclusion criteria

Research Physician:
Of the cases meeting the above eligibility criteria, those who meet any of the following conditions will be excluded from participation in this study.
(i) Those who cannot use a personal computer, smartphone, etc.
(ii) Other persons deemed by the principal investigator to be ineligible for the study (e.g., employed by the principal investigator, etc.)

Research Patients:
Of the patients who meet the above eligibility criteria, those who meet any of the following conditions will be excluded from participation in this study.
(i) Patients with a history of severe organic brain lesions or cognitive dysfunction.
(ii) Patients with a clinical diagnosis of a serious or unstable life-threatening physical condition at the time of screening.
(iii) Other subjects who are judged by the principal investigator to be ineligible for this study.

Target sample size

30

Name of lead principal investigator

1st name	Toshiaki
Middle name
Last name	Kikuchi

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry

Zip code

1608582

Address

Shinanomachi 35, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Email

t-kick.z3@keio.jp

Name of contact person

1st name	Toshiaki
Middle name
Last name	Kikuchi

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry

Zip code

1608582

Address

Shinanomachi 35, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Homepage URL

Email

t-kick.z3@keio.jp

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Comittee, Keio University School of Medicine

Address

Shinanomachi 35, Shinjuku-ku, Tokyo

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学病院（東京都）

Date of disclosure of the study information

2023

Year

10

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

10

Month

09

Day

Date of IRB

Anticipated trial start date

2023

Year

12

Month

10

Day

Last follow-up date

2028

Year

03

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Physicians are asked to consent to participate in the study. Then, physicians will use the depression treatment optimization tool on those patients who have agreed to participate in the study. The advice provided by the tool will be used as a reference material, and the usual treatment of depression will be continued. The study patients will report their self-reported depression ratings to their physicians, who will enter the ratings into the tool. 3 months of use of the tool will be followed by a questionnaire to be completed by both patients and physicians.

Registered date

2023

Year

10

Month

09

Day

Last modified on

2023

Year

10

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059861