Major depressive disorder and Mental illness with depression Major depressive disorder
Conditions
Interventions
None listed
Sponsors
Muraoka Hiroyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Persons aged from 20 to under 65 at the time of obtaining consent. 2) Those who were born, raised, and live in Japan and can understand Japanese at the time of obtaining consent. 3) Those who consent to being notified of incidental findings. 4) Those who are depressed and may have a mental illness. 5) Those who can understand the research explanation document and can obtain written consent voluntarily.
Exclusion criteria
Exclusion criteria: 1) Those who have been diagnosed with the following diseases that meet the DSM-5 criteria in the past: substance-related disorders, psychiatric disorders, schizophrenia spectrum disorders, bipolar disorders, compulsive disorders, PTSD, eating behavior disorders / eating Disorders, neurodevelopmental disorders, neurocognitive disorders, personality disorders, sleep contingencies. 2) Those who wish to become pregnant during the study period, those who are pregnant or may be pregnant, and lactating women. 3) Those who have a pacemaker. 4) Patients with hypothyroidism, Cushing's disease, systemic lupus erythematosus, Sjogren's syndrome, rheumatoid arthritis, Parkinson's disease, Huntington's disease, or multiple sclerosis. 5) Patients with convulsive disorders such as epilepsy. 6) Patients with any of serious diseases in liver, kidney, blood, respiratory organs, digestive organs, cardiovascular system, metabolic / electrolyte abnormalities, or severe hypersensitivity. (Patients diagnosed or under treatment for malignant tumors, diabetic patients with complications such as diabetic nephropathy and retinopathy, patients with degree III hypertension with contractile blood pressure of 180 mmHg or more in the examination room, etc.) 7) Patients undergoing sleep-disordered breathing and those with suspected severe sleep-disordered breathing 8) Those who have received the following treatment within the past 180 days from Visit 0. Pharmacotherapy: Central nervous system drugs (sleeping drugs, antidepressants, anti-manic drugs, mood stabilizers, antipsychotic drugs, anti-anxiety drugs, antiepileptic drugs), opioid drugs (Ritalin, Concerta, Opioid, etc.), Modafinyl, Steroids , Those who have taken interferon. Treatments other than drug treatment: Repeated transcranial magnetic stimulation therapy, electroconvulsive therapy 9) Those who have participated in other clinical studies within the past 90 days from Visit 0, or who plan to participate in other clinical studies during this study period. 10) Those who are scheduled to move or are expected to undergo major changes in their living environment during this research period. 11) Depression with psychotic features that do not match mood, those who are judged to be at risk of imminent suicide. 12) Those who are diagnosed as needing immediate medication on Visit1. 13) A person who is judged by the principal investigator or the doctor in charge to be inappropriate as a target person.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AS-PwR: Average power ratio (Non-rem period / REM period )of alpha and sigma band (8-14Hz)) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following indicators (electroencephalogram index and sleep index) and combinations of indicators(Including AS-PwR). (1) EEG index: AS15-No, AS15-Dr, AS20-No, AS20-Dr, AS30-No, AS30-Dr, AS-Pw, AS-PwR, A-PkNo,A-Pw, A-Pw+Ft, A-PwR, A-PwR+Ft, D-Pw, D-PwR, MD-Pw, MD-PwR, B-Pw, B-Pw+Ft, B-PwR, B-PwR+Ft, delta power, Theta power, alpha power, sigma power, beta power, all power, Cyclic Alternating Pattern (2) Sleep index: Time in bed, sleep onset latency, REM sleep latency, arousal index, number of awakenings, and sleep index derived from results of sleep staging. | — |
Contacts
Public ContactHiroyuki Muraoka
Yutaka Clinic
Outcome results
None listed