Psychedelic therapeutics in psychiatric conditions
Philip D. Harvey, Charles B. Nemeroff
Neuropsychopharmacology January 16, 2026 DOI: 10.1038/s41386-026-02335-z (opens in new tab)
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Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Topics | MDMA |
| Keywords | Clinical trial Regulatory agency Psychological intervention Drug development Psychotherapist Medline Drug trial Agency philosophy |
| Citations | 2 |
| Key findings | No psychedelic treatment has been approved for any psychiatric condition, and the one large-scale MDMA program that reached the FDA was disapproved for reasons that could apply to classical psychedelic trials. |
Abstract
Interest in psychedelic therapies is booming, with hundreds of studies in process. Despite the interest, there are no approved psychedelic treatments for any psychiatric condition. Further, the one large-scale development program using MDMA that reached the FDA was disapproved by the agency for reasons that could apply to clinical trials for classical psychedelics. We review the definitions of psychedelics, the current status of psychedelic therapies, conditions targeted, compounds under investigation, and the research/clinical strategies employed. Some treatment interventions include pharmacologically assisted psychotherapy, with both benefits and challenges associated with this strategy. There is debate about whether the psychedelic experience is a required fundamental element for therapeutic potential with the induced psychedelic state, rendering blinded clinical trials challenging. We address current societal issues, such as the deregulation of formerly illegal substances in some areas, that may affect development decisions. Our review also considers regulatory issues, including alternatives to blinded trials and whether some therapeutic targets, such as adjustment disorder, may pose hurdles if current regulatory standards are applied to these trials. The interest in psychedelic treatment is considerable, although the path forward has some complexities.
Comparable studies
Other narrative reviews on MDMA, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Human Pharmacology of MDMA | 2004 | Review | |
| Human psychopharmacology of Ecstasy (MDMA): a review of 15 years of empirical research | 2001 | Review | |
| 3,4‐Methylenedioxymethamphetamine (MDMA, “Ecstasy”): pharmacology and toxicology in animals and humans | 1994 | Review | |
| (±)3,4-Methylenedioxymethamphetamine (‘Ecstasy’)-Induced Serotonin Neurotoxicity: Studies in Animals | 2000 | Review | |
| Amphetamine toxicities | 2010 | Review |
Citations in the library
Cited by 2
- Overcoming Pharmacokinetic and Peripheral Safety Challenges in Psychedelic Therapies: The Promise of Advanced Drug Delivery Systems. ACS Pharmacology & Translational Science June 12, 2026
- Where is the sweet spot for psychedelic-enhanced fear extinction? An integrative quantitative synthesis of dose-effect patterns in rodent models. Journal of Psychopharmacology August 3, 2026
Cites 64
- Psychedelics Promote Structural and Functional Neural Plasticity Cell Reports June 1, 2018
- Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. New England Journal of Medicine November 3, 2022
- MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine June 1, 2021
- Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial Psychological Medicine June 15, 2018
- Quality of Acute Psychedelic Experience Predicts Therapeutic Efficacy of Psilocybin for Treatment-Resistant Depression Frontiers in Pharmacology January 17, 2018
and 59 more in the library