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

Last updated: January 7, 2025
Sponsor: S-Alpha Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Panic Disorders

Mood Disorders

Anxiety Disorders

Treatment

SAT014

Control

Clinical Study ID

NCT06734858
SAT014-KP-002
  • Ages > 19
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 writtenconsent by signing the participant information sheet and consent form

Exclusion

Exclusion Criteria:

  • Those diagnosed with schizophrenia, bipolar disorder type 1, or psychotic disorders

  • Those diagnosed with neurodevelopmental disorders, neurocognitive disorders, ororganic 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) orsevere alcohol use disordes

  • Those exhibiting active suicidal tendencies (suicidal thoughts, suicide attempts, orsuicidal behavior)

  • Those who have had a change in the type, dosage, or regimen of anxiolytics orantidepressants within 4 weeks of baseline

  • Those currently participating in another clinical trial or who have participated ina clinical trial within 90 days prior to the screening visit

  • Those deemed unsuitable for participation in the trial at the discretion of theinvestigator

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: SAT014
Phase:
Study Start date:
December 09, 2024
Estimated Completion Date:
October 09, 2025

Study Description

Stress-related mental disorders, including Post-Traumatic Stress Disorder (PTSD) and Adjustment Disorder (AD), are caused by traumatic experiences or significant stressors. These conditions can lead to social dysfunction, decreased quality of life, and increased suicide risk if untreated. With high global prevalence and rising patient numbers, existing treatments such as psychotherapy and pharmacotherapy have limitations. Digital therapeutics (DTx) offer a more accessible, cost-effective solution with less external exposure. Based on studies showing the effectiveness of therapies like EMDR and MBCT, SAT-014, a cognitive therapy software, was developed. An exploratory clinical trial was conducted to assess its initial safety and efficacy for alleviating symptoms of PTSD and AD. This trial, involving 110 participants over 19 years old, aims to evaluate SAT-014's efficacy in comparison with conventional treatments and assess its safety. The primary efficacy endpoint is the change in PCL-5 score at Week 6 (Visit 7) compared to baseline, while secondary endpoints include changes in PCL-5, IES-R, BAI, PHQ-9, HAM-A, CGI, and SF-12 scores at various time points.

Connect with a study center

  • Kyung Hee University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • SMG-SNU Boramae Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Wonju Severance Christian Hospital

    Wonju,
    Korea, Republic of

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.