JPRN-jRCTs032220107
Recruiting
Phase 1
Exploratory research on diagnostic performance of sleep scope depression diagnosis support system for healthy adults and patients with untreated depression
Kuriyama Kenichi0 sites138 target enrollmentJune 2, 2022
ConditionsMajor depressive disorder
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Major depressive disorder
- Sponsor
- Kuriyama Kenichi
- Enrollment
- 138
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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.
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
Outcomes
Primary Outcomes
Not specified
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