major depressive disorder
Conditions
Interventions
None listed
Sponsors
Medical Corporation Chiseikai Tokyo Center Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -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
| Measure | Time frame |
|---|---|
| -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). | — |
Countries
Japan
Contacts
Public ContactSatoko Shimizu
Medical Corporation Chiseikai Tokyo Center Clinic Clinical Research Group
Outcome results
None listed