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

Launched by S-ALPHA THERAPEUTICS, INC. · Dec 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new software program called SAT-014, designed to help people with Post-Traumatic Stress Disorder (PTSD) and Adjustment Disorders. The goal is to see if this program can reduce symptoms better than standard treatments currently available. Participants will also help researchers understand if the software is safe to use, which is important for getting approval from health authorities.

To join the trial, you need to be an adult aged 19 or older and have a diagnosis of PTSD or Adjustment Disorder. You should be able to use the internet and follow instructions on the app. If you have certain other mental health conditions or severe depression, you may not be eligible. If you participate, you'll be asked to use the software and report on how it's helping with your symptoms. This is an opportunity to contribute to research that could benefit others facing similar challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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 depression (Patient Health Questionnaire-9 (PHQ-9) ≥ 20)
• • Those with severe personality disorders
• • Those diagnosed with substance use disorders (excluding nicotine and caffeine) or severe alcohol use disordes
• • 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 currently participating in another clinical trial or who have participated in a clinical trial within 90 days prior to the screening visit
• • Those deemed unsuitable for participation in the trial at the discretion of the investigator