Clinical trial NCT06734858: Pivotal Trial of SAT-014 for Trauma and Stressor-Related Disorder Symptoms
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-traumatic Stress Disorder
Adjustment Disorders
Keywords: post-traumatic stress disorder (PTSD)
adjustment disorder (AD)
SaMD
Lead sponsor: S-Alpha Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-16
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score
timeFrame: baseline, 6 weeks
Secondary outcomes:
measure: Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks
measure: Change in Beck Anxiety Inventory (BAI) score
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks
measure: Change in (Patient Health Questionnaire-9 (PHQ-9) score
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks
measure: Change in Hamilton Anxiety Scale (HAM-A) score
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks
measure: Change in Clinical Global Impression-Severity (CGI-S) score
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks
measure: Clinical Global Impression-Improvement (CGI-I) score
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks
measure: Change in Impact of Event Scale - Revised (IES-R) score
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks
measure: Percentage of participants with a ≥10 point reduction in PTSD Checklist for DSM-5 (PCL-5) score
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Samsumg Medical Center
name: Hong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Kang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonju Severance Christian Hospital
name: Seo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyung Hee University Hospital
name: Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SMG-SNU Boramae Medical Center
name: Yoo, MD
role: PRINCIPAL_INVESTIGATOR
References: