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

NCT06734858 | Completed

• 1 other identifier: SAT014-KP-002
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 5

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).

Conditions

Post-traumatic Stress Disorder; Adjustment Disorders

Keywords

post-traumatic stress disorder (PTSD); adjustment disorder (AD); SaMD

Outcome Measures

Primary Outcomes (1)

• Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score

  The PTSD Checklist for DSM-5 (PCL-5) consist of 20 items, with a scale ranging from 0 to 4. Each item evaluates the frequency or intensity of specific symptoms over the past month. The scores are summed to produce a total severity score that ranges from 0 (minimum score) to 80 (maximum score). A higher scores indicate greater distress due to symptoms to past stressful experiences and a worse outcome.

  baseline, 6 weeks

Secondary Outcomes (8)

• Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score

  Baseline, 2 weeks, 4 weeks, 6 weeks

• Change in Beck Anxiety Inventory (BAI) score

  Baseline, 2 weeks, 4 weeks, 6 weeks

• Change in (Patient Health Questionnaire-9 (PHQ-9) score

  Baseline, 2 weeks, 4 weeks, 6 weeks

• Change in Hamilton Anxiety Scale (HAM-A) score

  Baseline, 2 weeks, 4 weeks, 6 weeks

• Change in Clinical Global Impression-Severity (CGI-S) score

  Baseline, 2 weeks, 4 weeks, 6 weeks

Study Arms (2)

SAT014 study group

EXPERIMENTAL

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)

Device: SAT014

Control group

OTHER

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

Other: Control

Interventions

SAT014 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.

SAT014 study group

Control 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.

Control group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• S-Alpha Therapeutics, Inc.: lead

Study Sites (5)

Kyung Hee University Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Adjustment Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Hong, MD

  Samsumg Medical Center

  PRINCIPAL INVESTIGATOR

• Kang, MD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• Seo, MD

  Wonju Severance Christian Hospital

  PRINCIPAL INVESTIGATOR

• Lee, MD

  Kyung Hee University Hospital

  PRINCIPAL INVESTIGATOR

• Yoo, MD

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: December 9, 2024
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: August 5, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)