UMIN-CTR Clinical Trial

Public title

Patients with major depressive disorder,Clinical study of sleep EEG measurement using DCT (Decentralized Clinical Trial)

Acronym

Patients with major depressive disorder,Clinical study of sleep EEG measurement using DCT (Decentralized Clinical Trial)

Scientific Title

Patients with major depressive disorder,Clinical study of sleep EEG measurement using DCT (Decentralized Clinical Trial)

Scientific Title:Acronym

Patients with major depressive disorder,Clinical study of sleep EEG measurement using DCT (Decentralized Clinical Trial)

Region

Japan

Condition

major depressive disorder

Classification by specialty

Psychosomatic Internal Medicine	Neurosurgery	Laboratory medicine
Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To determine whether home EEG measurements in patients with major depressive disorder are feasible in healthy adults and patients with major depressive disorder, using a telemetric electroencephalograph (Insomnograph M2). The study will also compare sleep variables between healthy adults and patients with major depressive disorder. A Decentralised Clinical Trial (DCT; Decentralised Clinical Trial) will be conducted using a remote system from recruitment of study subjects to EEG measurements.

Basic objectives2

Others

Basic objectives -Others

Observational studies without treatment intervention

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

-Completion rate of one consecutive week of measurements using telemetric electroencephalography in patients with major depressive disorder and healthy adults.
-Sleep variables from telemetric electroencephalography in patients with major depressive disorder and healthy adults (data for one week for each individual).
-Weekly variability of sleep variables from telemetric electroencephalography in patients with major depressive disorder and healthy adults.

Key secondary outcomes

-Variability of the following sleep variables from telemetric electroencephalography in patients with major depressive disorder and healthy adults over a 3-day (Monday-Wednesday) and 5-day (Monday-Friday) period
-Comparison of the following sleep variables between PSG and telemetric electroencephalography
-Comparison of sleep variables using HAM-D17 and telemetric electroencephalography (only in patients with major depression).

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients with major depressive disorder:
1.Japanese aged between 18 and 65 years with appropriate consent obtained in eConsent
2.Non-psychotic major depressive disorder (DSM-5) with persistent episodes.
3.Patients with a total score of 10 or more on the HAM-D (17 items) as assessed remotely by a physician or other person.
4.Persons who are using antidepressants (SSRIs, SNRIs, NaSSAs, tricyclic antidepressants, tetracyclic antidepressants) or sleeping pills (non-benzodiazepines) as standard treatment, who have been taking them for at least four weeks at a certain dosage and administration and whose doctor has judged that they are well tolerated and can continue without changing dosage and administration during the sleep EEG acquisition period Persons who are judged by the physician to be tolerating the drug without any problems and to be able to continue without changing the dosage during the sleep EEG acquisition period
5.Persons who are able to schedule the start of one consecutive week of home sleep EEG within 7 days of the PSG test.

Healthy adults:
1.Japanese aged between 18 and 65 years with appropriate consent obtained via eConsent
2.Able to schedule the start of one consecutive week of home sleep EEG within 7 days of the PSG test.

Key exclusion criteria

Patients with major depressive disorder:
1)Persons with schizophrenia and other comorbid psychotic disorders according to DSM-5 diagnostic criteria. Also, those receiving treatment for diseases of the respiratory system, circulatory system, digestive system, immune system, liver, kidney, haematopoietic function or endocrine function.
2)Persons with any of the following comorbidities based on DSM-5 diagnostic criteria: delirium, dementia, substance-related disorder, borderline personality disorder, eating disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, intellectual capacity disorder, autistic spectrum disorder.
3)Persons at significant risk of suicide who have had suicidal thoughts within the past 3months or suicidal behaviour within 1year prior to the start of the screening period, corresponding to items 4 or 5 of the Columbia Suicide Rating Scale (C-SSRS).
4)Patients who are hospitalised or scheduled to be hospitalised for treatment during the study period.
5)Persons who take benzodiazepines,lithium carbonate or antihistamine drugs during the study period from 2days before POINT2 to the end of POINT2 and from 2days before POINT3 to the end of POINT4.
6)Persons with alcohol abuse or illicit drug abuse or a history of such abuse.
7)Persons who are judged by the researcher or others to be unsuitable for the study.
Healthy adults:
1)Persons receiving treatment for diseases of the respiratory, circulatory, mental, nervous, digestive, immune, liver, kidney, haematopoietic or endocrine systems.
2)Persons for whom the Brief Structured Interview for Mental Illness (M.I.N.I.) screen version questionnaire suggests suspicion of a mental disorder or who have a history of such a disorder.
3)Persons who answered 'yes' to question 1 or 2 on suicidal ideation in the Columbia Suicide Rating Scale (C-SSRS), or who answered 'yes' to any of the questions on suicidal behaviour.
4)Same as 6) 7) above.

Target sample size

60

Name of lead principal investigator

1st name	Hirotaka
Middle name
Last name	Nagashima

Organization

Medical Corporation Chiseikai Tokyo Center Clinic

Division name

Clinical Research Group

Zip code

1030028

Address

Yaesu KT Building , 1-1-8, Yaesu, Chuo-ku, Tokyo

TEL

0332766935

Email

nagashima_hirotaka@tc-clinic.jp

Name of contact person

1st name	Satoko
Middle name
Last name	Shimizu

Organization

Medical Corporation Chiseikai Tokyo Center Clinic

Division name

Clinical Research Group

Zip code

1030028

Address

Yaesu KT Building, 1-1-8, Yaesu, Chuo-ku, Tokyo

TEL

0332766935

Homepage URL

Email

shimizu_satoko@tc-clinic.jp

Institute

Medical Corporation Chiseikai Tokyo Center Clinic

Institute

Department

Personal name

Organization

Ono Pharmaceutical co.,ltd

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Non Profit Organization Tokyo Allergy and Respiratory Disease Research Institute

Address

Riverside Tower Kuramae 3F, 1-8-6 Kuramae, Taito-ku, Tokyo

Tel

08073600910

Email

info@inclusion-p.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

61

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

Completed

Date of protocol fixation

2023

Year

08

Month

23

Day

Date of IRB

2023

Year

08

Month

25

Day

Anticipated trial start date

2023

Year

09

Month

01

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Although data suggesting a link between sleep disorders and major depressive disorder exist, a clear evaluation index has not been established with probability. EEG, an objective biomarker, is useful for detailed diagnosis of sleep disorders, but conventional sleep EEG measurement must be carried out at a medical institution with measuring equipment and a special environment, which limits the data that can be obtained. In recent years, it has become possible to perform multi-day EEG measurements at home using a telemetry EEG machine that has been certified as a medical device. Variations in sleep variables obtained from sleep EEG are expected to serve as a supplementary indicator for the typing of major depressive disorder and drug efficacy in the development of new drugs in the future. The present study will confirm the feasibility of home EEG measurements in patients with major depressive disorder for one week and compare them with sleep variables in healthy adults. Furthermore, this study will provide an opportunity to implement a Decentralised Clinical Trial (DCT) utilising a remote system from the study subjects to the EEG measurements.

Registered date

2023

Year

08

Month

31

Day

Last modified on

2024

Year

09

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059381