Clinical Trial to Preliminarily Assess the Safety and Feasibility of SAT-014, a Software for Alleviating Symptoms of Trauma and Stress-related Disorders

Launched by S-ALPHA THERAPEUTICS, INC. · May 27, 2024

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults (19 years and older)
• • 2. Have experienced clinically significant psychological trauma within the 6 months prior to screening visit
• • 3. Met the diagnostic criteria for Post-Traumatic Stress Disorder (PTSD) or Adjustment Disorder (AD) category as evaluated by MINI (Mini-International Neuropsychiatric Interview)
• • 4. Score between 17 and 38 points on the IES-R (Impact of Event Scale-Revised)
• • 5. Score of 4 or less on CGI (Clinical Global Impression)
• • 6. Capable of complying the activity instructions provided the app
• Exclusion Criteria:
• • 1. Have been diagnosed with schizophrenia, bipolar disorder, and psychotic disorder
• • 2. Have been diagnosed with neurodevelopmental disorder, neurocognitive disorder, or organic mental disorder
• • 3. Severe depression (PHQ-9 score of 20 or greater)
• • 4. Comorbid with severe personality disorder
• • 5. Diagnosed with substance use disorder excluding nicotine and caffeine and with severe alcohol use disorder
• • 6. Have made a suicide attempt within 3 months and are judged to be at high risk for suicide by a psychiatrist
• • 7. Pregnant or lactating
• • 8. Currently participating in another clinical trial or have participated in another trial within 90 days from screening
• • 9. Others deemed unsuitable for participation in this clinical trial at the discretion of the investigator due to ethical concerns or potential impact on the trial outcome