None listed
Conditions
Interventions
Medical Device : 1. Main Intervention
The main intervention of this study is the application of Minds.NAVI, a biomarker-based psychological assessment software.
2. Minds.NAVI Components
Minds.NAVI in
Sponsors
Yonsei University Health System, Gangnam Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Depressive Symptom Rating Scale (K-QIDS-SR) score of 11 or more 2) Patients with major depressive disorder according to DSM-5 diagnostic criteria
Exclusion criteria
Exclusion criteria: 1) Have a physical disease that may cause depressive symptoms (e.g. thyroid dysfunction, uncontrolled diabetes, etc.) or have taken treatment medications that may affect depressive symptoms (e.g. hormones, oral steroids, etc.) in the past 3 months or patients with a history of taking medications (ointments, oral contraceptives, painkillers, anti-inflammatory drugs, etc.) 2) Those with adrenal dysfunction (Cushing's syndrome, Addison's disease, adrenal tumor, pituitary tumor, etc.) or other endocrine or gynecological diseases (such as polycystic ovary syndrome, menstrual irregularities, irregular bleeding, etc.) 3) Patients with coexisting major mental illnesses such as schizophrenia and bipolar disorder 4) Patients suspected of having intellectual disability (shortened intelligence test score less than 70) 5) Those who have received oral treatment (e.g. tooth extraction, tonsil surgery, etc.) within the past 2 weeks 6) Pregnant or lactating women 7) Patients with serious physical diseases (cancer, tuberculosis, etc.) 8) Foreigners and illiterate people who cannot read the consent form 9) Other people who are unable to participate in this clinical trial at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intergroup comparison of Mindsnavi profiles according to episodes of Major Depressive Disorder (mild episode/moderate episode/severe episode) | — |
Secondary
| Measure | Time frame |
|---|---|
| Index of correlation between salivary and blood cortisol levels;Index of correlation between salivary and blood Dehydroepiandrosterone (DHEA) levels;Correlation between psychological rating scales (Hamilton Depression Rating Scale(HAM-D), Korean version of the Quick Inventory of Depressive Symptomatology – Self Report(K-QIDS-SR), PROtective and Vulnerable factors battEry test(PROVE test), Generalized Anxiety Disorder-7(GAD-7), Perceived Stress Scale(PSS)) and salivary hormone levels (Cortisol and DHEA);The relationship between psychological evaluation scales (Hamilton Depression Rating Scale(HAM-D), Korean version of the Quick Inventory of Depressive Symptomatology – Self Report(K-QIDS-SR), PROtective and Vulnerable factors battEry test(PROVE test), Generalized Anxiety Disorder-7(GAD-7), Perceived Stress Scale(PSS)) and heart rate variability (HRV);The association between heart rate variability (HRV) and salivary hormone levels (cortisol, Dehydroepiandrosterone(DHEA));The correlation between heart rate variability (HRV) measurements obtained from devices used in this clinical trial (e.g., MobiCare, smart bands) and conventional hospital-grade heart rate variablity(HRV) equipment (standard deviation of normal-to-normal intervals (SDNN), total power (TP), low-frequency component (LF), low-frequency to high-frequency ratio (LF/HF), physical stress index (PSI), and mental stress index (MSI));This study compares the Mindsnavi profile outcomes between individuals diagnosed with Major Depressive Disorder (MDD) and a matched healthy control group. | — |
Countries
Korea, Republic of
Contacts
Public ContactShin Hyun-Kyung
Yonsei University Health System, Gangnam Severance Hospital
Outcome results
None listed