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

NCT06734858 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-08-05

No results posted yet for this 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).

Conditions

  • Post-traumatic Stress Disorder
  • Adjustment Disorders

Interventions

DEVICE

SAT014

SAT-014 in Combination with Baseline Conventional Treatment Participants in this arm will use the SAT-014 application for 6 weeks in combination with their baseline conventional treatment, which may include pharmacological therapy or simple counseling (excluding cognitive behavioral therapy and psychoanalytic counseling therapy). The aim of this study is to assess the efficacy and safety of SAT-014 for alleviating symptoms of trauma and stressor-related disorders, such as PTSD and adjustment disorder.

OTHER

Control

Baseline Conventional Treatment Participants in this arm will receive only conventional treatment, which includes the medication they were taking at baseline for the indication or the basic counseling therapy they were receiving at baseline.

Sponsors & Collaborators

  • S-Alpha Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Hong, MD · Samsumg Medical Center

  • Kang, MD · Severance Hospital

  • Seo, MD · Wonju Severance Christian Hospital

  • Lee, MD · Kyung Hee University Hospital

  • Yoo, MD · SMG-SNU Boramae Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-09
Primary Completion
2025-05-29
Completion
2025-05-29

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06734858 on ClinicalTrials.gov