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
Multifaceted Intervention to Restore Resilience and Overcome Risk
The MIRROR study will compare the effectiveness of two interventions in improving emotion regulation and reducing PTSD symptoms in female Veterans with military sexual trauma (MST) and/or intimate partner violence (IPV) and co-occurring brain injury.
Boosting Refugee Integration Through Psychological Intervention
Refugees and asylum seekers (RAS) face numerous stressors and adversities which put them at risk for developing mental health problems. However, access to adequate mental health care in host countries is limited. To address this problem, the World Health Organization (WHO) introduced Problem Management Plus (PM+), a short, low-intensity psychological intervention administered by non-professionals, aiming to alleviate common mental disorders among crisis-affected communities. The present study aims at expanding the existing PM+ intervention by providing additional booster sessions and homework reminders while evaluating its effectiveness and implementation in the public health system.