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

NCT ID: NCT06734858

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-09
• Study Completion Date: 2025-05-29

Brief 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).

Detailed 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.

Conditions

Post-traumatic Stress Disorder; Adjustment Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAT014 study group

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)

Group Type: EXPERIMENTAL

SAT014

Intervention Type: DEVICE

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.

Control group

Conventional treatment*

*Conventional treatment: Pharmacological treatment received at baseline for the indication or simple counseling (excluding cognitive behavioral therapy and psychoanalytic counseling therapy)

Group Type: OTHER

Control

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S-Alpha Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hong, MD

Role: PRINCIPAL_INVESTIGATOR

Samsumg Medical Center

Kang, MD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Seo, MD

Role: PRINCIPAL_INVESTIGATOR

Wonju Severance Christian Hospital

Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee University Hospital

Yoo, MD

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Locations

Kyung Hee University Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Wonju Severance Christian Hospital

Wŏnju, , South Korea

Countries

South Korea

Other Identifiers

SAT014-KP-002

Identifier Type: -

Identifier Source: org_study_id