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Clinical Trials/JPRN-UMIN000052065
JPRN-UMIN000052065
Recruiting
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Patients with major depressive disorder,Clinical study of sleep EEG measurement using DCT (Decentralized Clinical Trial) - Patients with major depressive disorder,Clinical study of sleep EEG measurement using DCT (Decentralized Clinical Trial)

Medical Corporation Chiseikai Tokyo Center Clinic0 sites60 target enrollmentSeptember 1, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
major depressive disorder
Sponsor
Medical Corporation Chiseikai Tokyo Center Clinic
Enrollment
60
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 1, 2023
End Date
March 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Medical Corporation Chiseikai Tokyo Center Clinic

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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