A multi-center, single-arm, prospective confirmatory clinical trial to evaluate the efficacy of ‘Minds.NAVI™’ for major depressive disorder screening

Hallym University Medical Center0 个研究点目标入组 123 人开始时间: 待定最近更新: 2024年7月23日

适应症

试验速览

暂无简介。

•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

•[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
•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

发起方