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Exploratory Clinical Trial of a Depression Diagnostic Software That Integrates Stress Biomarkers and Composite Psychometrics

 Sooah Jang  ;  In-Young Kim  ;  Sun-Woo Choi  ;  Anna Lee  ;  Ju-Yeal Lee  ;  Hyunkyung Shin  ;  Junwoo Lee  ;  Mikyeong Lee  ;  Kyoung-Ryul Lee  ;  Saeeun Jung  ;  Jin Sun Ryu  ;  Jihee Oh 2  ;  Manjae Kwon  ;  Joohan Kim  ;  Ryunsup Ahn  ;  Young-Chul Jung  ;  Jeong-Ho Seok 
 PSYCHIATRY INVESTIGATION, Vol.21(3) : 230-241, 2024-03 
Journal Title
Issue Date
Biomarker ; Cortisol ; Depression ; Diagnosis ; Hypothalamic–pituitary–adrenal axis ; Salivary hormone
Objective This study evaluated the clinical effectiveness of Minds.NAVI, a depression screening kit combining psychometric measures and stress hormone biomarkers, in a prospective clinical trial. The objective was to assess its potential as a depression screening tool and investigate the associations between psychological assessments, salivary hormone staging, and depression severity.Methods Thirty-five participants with major depressive disorder and 12 healthy controls (HCs) were included. The Minds.NAVI software, utilizing the PROtective and Vulnerable factors battEry Test (PROVE) and salivary cortisol/dehydroepiandrosterone (DHEA) analysis, was employed. The PROVE test is a comprehensive self-report questionnaire that assesses depressive symptoms, suicide risk, attachment style, adverse childhood experiences, mentalization capacity, and resilience. In addition, salivary cortisol and DHEA levels were measured to evaluate the functional stage of the hypothalamic–pituitary–adrenal (HPA) axis.Results Minds.NAVI exhibited 100% sensitivity, 91.7% specificity, and 97.9% accuracy in distinguishing depression from HCs within an exploratory small group. Salivary stress hormone phases showed changes with depression stage (p=0.030), and the proportion of patients with “adrenal exhaustion stage” was higher in the moderate/severe depression group (p=0.038). Protective/vulnerable factors differed significantly between controls and depressed groups (p<0.001). Cortisol awakening response inversely correlated with depressive symptom severity (r=-0.31, p=0.034).Conclusion This study suggested possible clinical effectiveness of Minds.NAVI, a depression screening tool that integrates psychometric measures and stress hormone biomarkers. The findings support the potential association between depression, chronic stress, and HPA axis hyporesponsiveness.
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1. College of Medicine (의과대학) > Dept. of Psychiatry (정신과학교실) > 1. Journal Papers
Yonsei Authors
Kwon, Manjae(권만재)
Seok, Jeong Ho(석정호) ORCID logo https://orcid.org/0000-0002-9402-7591
Jang, Soo Ah(장수아)
Jung, Young Chul(정영철) ORCID logo https://orcid.org/0000-0002-0578-2510
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