Exploratory research on diagnostic performance of sleep scope depression diagnosis support system

JRCT ID: jRCTs032220107

Registered date:02/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Major depressive disorder
• Date of first enrollment: 03/08/2022
• Target sample size: 138
• Study type: Interventional

Intervention(s)

<Prohibited drugs / Prohibited therapy>
Up to Visit 2, drugs for central nervous system (hypnotics, antidepressants, antipsychotics, anti-manic drugs, mood stabilizers, anxiolytics, antiepileptic drugs), opioid drugs (ritalin, concerta, opioid, etc.) and modafinyl, Steroids and interferons are prohibited.
In addition, electroconvulsive therapy, transcranial magnetic stimulation therapy, and high-intensity phototherapy are prohibited throughout the study period.
<Restrictive drug>
At Visit 2, drug treatment for patients whose main disease has been diagnosed as depression is limited to Escitalopram and Mirtazapine. For the treatment of patients whose main disease is diagnosed as a psychiatric disorder other than depression, it is possible to administer a central nervous system agent as needed at the discretion of the doctor. The dosage, dosage and administration period shall be the clinically necessary dosage, administration and administration period according to the package insert.

Outcome(s)

• Primary Outcome: AS-PwR: Average power ratio (Non-rem period / REM period )of alpha and sigma band (8-14Hz))

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 64age old
• Gender: Both

Include criteria

[Common Criteria for depressed patients and healthy controls]
1) Persons aged from 20 to under 65 at the time of obtaining consent.
2) Those who live in Japan and can understand Japanese at the time of obtaining consent.
3) Those who wish to be notified of accidentally discovered medical findings.
4) Those who can understand the research explanation document and can obtain written consent voluntarily.
[Criteria for candidate for depression]
5) Those who have insomnia / depression and may have depression.
[Criteria for healthy controls]
6) Those who have no symptoms of depression / insomnia and have no possibility of mental illness, or those who have never been diagnosed with mental illness in the past.

Exclude 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 were not diagnosed with depression by SCID evaluation in the "depression candidate group", and those who were judged to have some mental illness by SCID evaluation in the "control healthy group".
13) Persons who have been confirmed to have a brain organic disorder by head imaging examination. (It will be cancelled as soon as the test result is confirmed)
14) Those who are judged to require treatment with benzodiazepine receptor agonists. (Cancelled as soon as it is confirmed after Visit 0)
15) Those who are diagnosed as needing immediate medication on Visit0 and Visit1.
16) a person who is judged by the principal investigator or the doctor in charge to be inappropriate as a target person.

Related Information

• Primary Sponsor: Kuriyama Kenichi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development