Pivotal Trial of SAT-014 for Trauma and Stressor-Related Disorder Symptoms
Key facts
- Who runs it
- S-Alpha Therapeutics, Inc.
- Where
- South Korea5 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 110 people enrolled
- Started
- 9 Dec 2024
- Ended
- 29 May 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- SAT014
- Control
- Record updated
- 5 August 2025
Who can take part
- Age
- 19 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The aim of this study is to evaluate the efficacy of SAt-014, a software as a medical device (SaMD), in alleviating symptoms of trauma and stressor-related disorders in patients with post-traumatic stress disorder (PTSD) or adjustment disorder (AD), compared to standard treatment, and to assess its safety for regulatory approval by the Ministry of Food and Drug Safety (MFDS).
The 2 groups in the trial
- SAT014 study groupTreatment being tested
SAT-0014 + Conventional treatment\* \*Conventional treatment: Pharmacological treatment received at baseline for the indication or simple counseling (excluding cognitive behavioral therapy and psychoanalytic counseling therapy)
Treatment: SAT014
- Control groupOther group
Conventional treatment\* \*Conventional treatment: Pharmacological treatment received at baseline for the indication or simple counseling (excluding cognitive behavioral therapy and psychoanalytic counseling therapy)
Treatment: Control
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Multicenter, Randomized, Open-label, Controlled, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of Software SAT-014 for the Alleviation of Symptoms Related to Trauma and Stressor-related Disorders
- Record updated
- 5 August 2025