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

S-Alpha Therapeutics

Status: Completed

Conditions: Adjustment Disorders; Post-traumatic Stress Disorder

Treatments: Other: Control; Device: SAT014

Study type: Interventional

Funder types: Industry

Identifiers

NCT06734858

SAT014-KP-002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

SAT014 study group

Experimental group

Description:

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)

Treatment:

Device: SAT014

Control group

Other group

Description:

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

Treatment:

Other: Control