Issues in Clinical Trial Design—Lessons From the FDA’s Rejection of MDMA
Samuel T. Wilkinson, Gerard Sanacora
JAMA Psychiatry April 16, 2025 DOI: 10.1001/jamapsychiatry.2025.0442 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Viewpoint Peer reviewed |
|---|---|
| Topics | MDMA |
| Keywords | Clinical trial Blinding Clinical research Pharmacology |
| Citations | 14 |
| Key points | The FDA rejected MDMA as a treatment for PTSD due to concerns about lack of blinding and clinical trial integrity. |
Abstract
This Viewpoint explores potential justifications underlying the US Food and Drug Administration (FDA)’s rejection of methylenedioxymethamphetamine (MDMA) as a treatment for posttraumatic stress disorder, including lack of blinding and issues around the integrity of relevant clinical trials.