Pivotal Trial of SAT-014 for Trauma and Stressor-Related Disorder Symptoms

Ki vehet részt

• Adults aged 19 years or older
• Diagnosed with Post-Traumatic Stress Disorder (PTSD) or Adjustment Disorder (AD) according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
• A score of 3 to 4 on the Clinical Global Impression-Severity (CGI-S) scale
• Able to access the internet and respond to app activity instructions
• Voluntarily decided to participate in this clinical trial and provided written consent by signing the participant information sheet and consent form

Ki nem vehet részt

• Those currently participating in another clinical trial or who have participated in a clinical trial within 90 days prior to the screening visit
• Those diagnosed with schizophrenia, bipolar disorder type 1, or psychotic disorders
• Those diagnosed with neurodevelopmental disorders, neurocognitive disorders, or organic mental disorders
• Those with severe personality disorders
• Those diagnosed with substance use disorders (excluding nicotine and caffeine) or severe alcohol use disordes
• Those with severe depression (Patient Health Questionnaire-9 (PHQ-9) ≥ 20)
• Those exhibiting active suicidal tendencies (suicidal thoughts, suicide attempts, or suicidal behavior)
• Those who have had a change in the type, dosage, or regimen of anxiolytics or antidepressants within 4 weeks of baseline
• Those deemed unsuitable for participation in the trial at the discretion of the investigator