UMIN-CTR Clinical Trial

Public title

Development of depression assessment tool utilizing simple electroencephalograph

Acronym

Depression assessment by simple electroencephalograph

Scientific Title

Development of depression assessment tool utilizing simple electroencephalograph

Scientific Title:Acronym

Depression assessment by simple electroencephalograph

Region

Japan

Condition

depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To develop algorithm to distinguish depression from healthy people utilizing simplified Electroencephalograph

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

electroencephalogram frequency pattern

Key secondary outcomes

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients diagnosed as depression based on DSM-5 who are 20 years old or older
2) Decisionally not impaired judged by treating physician

Key exclusion criteria

1) Patients who have difficulties in measuring EEG because of physical or psychiatric disorder
2) Patients who have comorbid psychiatric disorder other than depression
3) Patients who have comorbidities that can interfere with the measurements of EEG; such as patients with brain tumor, stroke or epilepsy
4) Those who are considered to be ineligible by the PI or investigators.

Target sample size

40

Name of lead principal investigator

1st name	Taishiro
Middle name
Last name	Kishimoto

Organization

Keio University School of Medicine

Division name

Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes

Zip code

106-0032

Address

Roppongi Hills North Tower 7F, 6-2-31 Roppongi, minato-ku, Tokyo, Japan

TEL

03-5786-0006

Email

tkishimoto@keio.jp

Name of contact person

1st name	Taishiro
Middle name
Last name	Kishimoto

Organization

Keio University School of Medicine

Division name

Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes

Zip code

106-0032

Address

Roppongi Hills North Tower 7F, 6-2-31 Roppongi, minato-ku, Tokyo, Japan

TEL

03-5786-0006

Homepage URL

http://www.i2lab.info/

Email

tkishimoto@keio.jp

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

pending

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Asaka hospital

Name of secondary funder(s)

Organization

The Clinical and Translational Research Center

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN

Tel

0353633961

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）
あさかホスピタル（東京都）

Date of disclosure of the study information

2017

Year

06

Month

25

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

No longer recruiting

Date of protocol fixation

2016

Year

10

Month

31

Day

Date of IRB

2016

Year

11

Month

28

Day

Anticipated trial start date

2016

Year

12

Month

05

Day

Last follow-up date

2026

Year

11

Month

28

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study participants will wear simple electroencephalogram and record EEG for 1 minute each while their eyes opened and closed. Then participants will have interview with psychologist/psychiatrist and are assessed their depression severity/cognitive function using assessment scales described below. Participants will fill out self rating scale too. This measurement will take place up to three times (on different days) for each participant.
The assessment scales/test are as follows: Hamilton rating scales for depression, Montgomery Asberg depression rating scale, word fluency test, Beck depression inventory.
In addition, participants' demographic characteristics such as medication, treatment history, and current clinical global impression scale-severity will be recorded from chart as well as interview to participants' treating physicians.

The data collected from study participants and normal reference data are labeled as depression and normal respectively. Utilizing noise reduction method invented by study group and machine learning approach, we aim to develop algorithm to distinguish depression to normal. We also aim to develop an algorithm to predict patients' severity based on EEG information.

Registered date

2017

Year

06

Month

25

Day

Last modified on

2022

Year

01

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031931