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

Not Applicable

Recruiting

• Conditions: major depressive disorder

• Registration Number: JPRN-UMIN000052065
• Lead Sponsor: Medical Corporation Chiseikai Tokyo Center Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-01
• Last Update Posted: 17 October 2023
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-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.

Secondary Outcome Measures

Name	Time	Method
-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).