None listed
Conditions
Interventions
Medical Device : 1. Target: Patients with major depressive disorder and suicide risk
2. Main content of arbitration:
- The main intervention content is the Minds.NAVI program to screen for major depre
Sponsors
Hallym University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Selection criteria for major depressive disorder patient group 1) Men and women between 19 and 50 years of age as of the date of written consent 2) At the time of the screening visit, those who have a history of or been diagnosed with major depressive disorder according to the diagnostic criteria of DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, fifth edition) in the Mini International Neuropsychiatric Interview (MINI) 3) Those with a score of 11 or more on the Korean Quick Inventory of Depressive Symptomatology-Self Rated (K-QIDS-SR) at the screening visit 4) Those who voluntarily signed a written consent form 5) A person who can understand and comply with the clinical trial procedures and visit schedule 2. Standards for selection of normal population 1) Men and women between 19 and 50 years of age as of the date of written consent 2) At the time of the screening visit, those who do not meet a significant psychiatric diagnosis in each module of the Clinician Evaluation Interview (MINI) 3) Those with a score of 5 or less on the Depressive Symptom Rating Scale (K-QIDS-SR) at the screening visit 4) Those who voluntarily signed a written consent form 5) A person who can understand and comply with the clinical trial procedures and visit schedule
Exclusion criteria
Exclusion criteria: [Current disease and medical history] 1) People with metabolic or endocrine diseases that may cause depressive symptoms (e.g. thyroid dysfunction, uncontrolled diabetes, etc.) 2) Those with adrenal dysfunction (Cushing's syndrome, Addison's disease, adrenal tumor, pituitary tumor, etc.) 3) For women, those with polycystic ovary syndrome, uterine fibroids, or ovarian cancer that may affect cortisol hormone. 4) Those with coexisting major mental illnesses such as schizophrenia and bipolar disorder 5) Patients with serious physical diseases (cancer, tuberculosis, etc.) [Concomitant contraindications] 6) Those who have taken treatment drugs (e.g. hormones, oral steroids, etc.) that may affect depressive symptoms within 12 weeks prior to screening 7) Those with a history of drug or alcohol abuse or drug dependence within 24 weeks prior to screening [etc] 8) Persons with severe intellectual disability as determined by the examiner 9) Persons who have received oral treatment (e.g. tooth extraction, tonsil surgery, etc.) within the past 2 weeks 10) Pregnant or lactating women 11) Foreigners and illiterate people who cannot read the informed consent form 12) Other people judged by the investigator to be unsuitable for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of Minds.NAVI™ for patients with major depressive disorder (positive) and normal group (negative) | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive predictive value (PPV) of Minds.NAVI™ for patients with major depressive disorder;Negative predictive value (NPV) of Minds.NAVI™ for patients with major depressive disorder;Comparison of mean differences between groups for the three main questionnaires (K-QIDS-SR, HAMD-17, MADRS) for evaluating symptoms of major depressive disorder in the normal group and patient group diagnosed with a test device.;Evaluation of correlation between groups for biomarkers (cortisol, DHEA) in normal and patient groups diagnosed with test equipment;Comparison of differences in distribution of adrenal cortex function response stage (normal/acute tress/transition/chronic exhaustion stage) based on the ratio of biomarkers (cortisol, DHEA) between normal and patient groups diagnosed with test equipment.;Evaluation of inter-group correlation for biomarkers (cortisol, DHEA) in normal and patient groups diagnosed using reference standards;Comparison of differences in distribution of adrenal cortex function response stage (normal/acute stress/transition/chronic exhaustion stage) based on the ratio of biomarkers (cortisol, DHEA) between normal group and patient group diagnosed by reference standard.;Evaluation of correlation between subtypes (atypical depression, melancholic depression) for biomarkers (cortisol, DHEA) in patient group diagnosed with reference standard;Comparison of mean differences between groups for the scores of the subfactors of the PROVE battery evaluation (PROVE-DS, PROVE-SR, PROVE-ACE, PROVE-AAT, PROVE-MC, PROVE-KRQ) in the normal group and patient group diagnosed as a reference standard.;Correlation analysis between biomarkers (cortisol, DHEA) and psychological evaluation scores (PROVE subdomain, K-QIDS-SR, HAMD-17, MADRS) in normal and patient groups diagnosed using reference standards | — |
Countries
Korea, Republic of
Contacts
Public ContactRYU VIN
Hallym University Medical Center
Outcome results
None listed