What the trial was testing
The trial enrolled 26 patients with post-traumatic stress disorder. The study was sponsored by Resilient Pharmaceuticals and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). 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
PTSD scores fell about 5 times more on active MDMA doses than on the low control dose.
The Lancet Psychiatry · 2018 · NCT01211405
These findings — that in PTSD symptoms on active MDMA doses vs. low-dose control during therapy — were published in the The Lancet Psychiatry and represent the headline result of the study.
Researchers tracked outcomes across 26 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 post-traumatic stress disorder, 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
MDMA-assisted therapy is NOT yet FDA-approved. The FDA rejected an approval application in August 2024, citing concerns about the trial design and data quality. The treatment is not approved or available outside of clinical trials. Approved PTSD treatments include sertraline, paroxetine, and trauma-focused psychotherapy. Ask a mental health professional about evidence-based options.
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 post-traumatic stress disorder trials
Efficacy of a Multi-level School Intervention for LGBTQ Youth
Efficacy of a Multi-level School Intervention for LGBTQ Youth
Mindfulness-based Psilocybin Therapy for PTSD
The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomized, controlled study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using EEG/EMG and multimodal MRI measures after administration of one oral dose of psilocybin, accompanied either with standard "psychological support" only; or with standard support plus Mindfulness-based Cognitive Therapy (MBCT).