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 via OpenAlex
Summary
AI-generated from the abstractThe US Food and Drug Administration rejected MDMA as a treatment for posttraumatic stress disorder, citing concerns about lack of blinding and integrity issues in the clinical trials that had been conducted. This viewpoint examines the potential justifications for that decision.
Study at a glance
| Characteristics | Viewpoint Peer reviewed |
|---|---|
| Topics | MDMA |
| Keywords | Clinical trial Blinding Clinical research Psychiatry |
| Citations | 14 |
| Key finding | 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.