Health · Medical Research · 4 hrs ago
Review finds low-certainty evidence for MDMA-assisted PTSD therapy
A review of six randomized trials involving 286 people found that MDMA-assisted psychotherapy led to greater short-term improvement in PTSD symptoms than control treatment.
The review rated the overall evidence low certainty, and found that remission was more than twice as likely with the therapy.
PTSD can cause intrusive memories and avoidance, and MDMA may make some patients more receptive to psychotherapy, though how it works remains uncertain.
The trials shared one sponsor and similar therapy methods, so they were not six independent replications.
The FDA declined to approve the treatment in August 2024, citing concerns including whether participants could tell if they had received MDMA and questions about safety and the reliability of the results.
Resilient Pharmaceuticals, formerly Lykos, reportedly resubmitted its application in August 2026.
The FDA will need to assess the application, while questions about trial quality and lasting recovery remain.
An October 2026 review rated the evidence for MDMA-assisted therapy for PTSD as low certainty.
The review analyzed six randomized trials involving 286 participants.
The pooled results showed greater short-term improvement and more than twice the likelihood of remission compared with control treatment.
The authors noted concerns about trial blinding, shared sponsorship and the use of related psychotherapy protocols.
The review found no statistically significant improvement in depression.
- Who
- Researchers including Brooke Sevchik, a Stanford Ph.D. student, reviewed the evidence.
- What
- A review assessed MDMA-assisted therapy for PTSD and rated the evidence as low certainty.
- When
- October 2026.
- Where
- Not stated
- Why
- To assess how certain the evidence is about the therapy’s effects.
This story does not have two clearly opposing sides.
The FDA declined approval of MDMA-assisted therapy, citing concerns that included inadequate blinding and safety.
A presidential initiative accelerated psychedelic research.
Resilient Pharmaceuticals reportedly resubmitted its application to the FDA.
A review reported low-certainty evidence from six randomized trials.
- Trials analyzed
- 6 randomized trials
- Participants
- 286
- Evidence rating
- Low certainty
- Short-term outcomes
- Greater improvement than control treatment
- PTSD remission
- More than twice as likely with MDMA-assisted therapy in the pooled analysis
- Depression
- No statistically significant improvement in the review