JPRN-jRCTs032220107招募中1 期
Exploratory research on diagnostic performance of sleep scope depression diagnosis support system for healthy adults and patients with untreated depression
Kuriyama Kenichi0 个研究点目标入组 138 人开始时间: 2022年6月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 138
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 64age old（—）
- 性别
- All
入选标准
- •[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.
排除标准
- •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.
研究者
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