Trials
Search / Trial NCT06439407

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

Trial Information

Current as of February 14, 2025

Completed

Keywords

ClinConnect Summary

No description provided

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

About S Alpha Therapeutics, Inc.

s-alpha therapeutics, inc. is a pioneering biopharmaceutical company dedicated to advancing innovative therapies for unmet medical needs. With a focus on harnessing cutting-edge research and development in the field of therapeutic proteins, s-alpha therapeutics aims to improve patient outcomes through the discovery and commercialization of novel treatments. The company is committed to rigorous clinical trials and collaboration with healthcare professionals to ensure the safety and efficacy of its products, ultimately enhancing the quality of life for patients around the world.

Locations

Seoul, , Korea, Republic Of

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0