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.
Citations in the library
Cited by 10
- Psychological Therapy Quantity and Depressive Symptom Reduction in Psychedelic-Assisted Therapy: A Systematic Review and Meta-Analysis. JAMA Network Open January 2, 2026
- Subjective and neurocognitive profiling of clinical doses of 3,4-methylenedioxymethamphetamine (MDMA) in healthy volunteers: implications for therapeutic use Molecular Psychiatry April 8, 2026
- Placebo Effects in the Treatment of Depression-Implications for the Psychedelic Renaissance. Neurologic Clinics February 1, 2026
- Novel approaches in depression treatment: from rapid-acting antidepressants to personalized interventions. Molecular Psychiatry June 25, 2026
- R-MDDMA is a Safer Analogue of MDMA with Therapeutic Potential. ACS Chemical Neuroscience May 6, 2026
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