What the trial was testing
The trial enrolled 450 patients with ptsd. The study was sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
The combination reduced PTSD symptoms by about 5.6 points more than sertraline alone.
JAMA psychiatry · 2025 · NCT04124614
These findings — that the combination reduced PTSD symptoms more than sertraline alone on a standard symptom scale. — were published in the JAMA psychiatry and represent the headline result of the study.
Researchers tracked outcomes across 450 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with ptsd, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was a large-scale study showing the combination worked better than sertraline alone. However, this combination is not yet FDA-approved for PTSD. Talk to your doctor about whether currently approved PTSD treatments are right for you, or ask about clinical trials testing this combination.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open ptsd trials
Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App
The purpose of this study is to demonstrate the feasibility and utility of SIT delivered asynchronously (self-paced) via fully virtual platform with and without the aid of a mobile health application and to determine initial change over baseline in terms of reduction in PTSD symptoms and improvement in resiliency in participants receiving the virtual SIT prototype, using Linear Mixed Models (LMMs),
Improving Behavioral Health for Caregivers and Children After Pediatric Injury
Pediatric traumatic injury (PTI) is a public health priority, with more than 125,000 children experiencing injuries that require hospitalization each year. These children, and their caregivers, are affected in many ways that may affect quality of life, emotional and behavioral health, physical recovery, family roles and routines, and academic functioning; yet US trauma centers do not adequately address these outcomes and a scalable national model of care for these families is needed. This proposal builds on prior research from the investigative team to test a technology-assisted, stepped care behavioral health intervention for children (\<12 years) and their caregivers after PTI, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), via a hybrid type I effectiveness-implementation trial with 348 families randomly assigned to CAARE (n=174) vs. guideline-adherent enhanced usual care (EUC) (n=174).