Registered clinical studies investigating psychedelic drugs for psychiatric disorders.
Ashley N. Siegel, Shakila Meshkat, Katie Benitah, Orly Lipsitz, Hartej Gill, Leanna M.W. Lui, Kayla M Teopiz, Roger S McIntyre, Joshua D. Rosenblat
Journal of Psychiatric Research July 1, 2021 DOI: 10.1016/j.jpsychires.2021.05.019 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Sample size | 70 |
| Population | Registered clinical trials on clinicaltrials.gov evaluating psychedelics for psychiatric disorders |
| Topics | Ayahuasca Depression DMT Ibogaine LSD MDMA PTSD Psilocybin |
| Keywords | Psychiatric disorders Psychedelic therapy: psychedelics Innovative treatments Exploring Investigating |
| Citations | 101 |
| Key findings | As of December 2020, 70 registered clinical trials investigate psychedelics for psychiatric disorders, with the majority studying MDMA and psilocybin for PTSD and major depressive disorder, and only 21 studies have published results. |
Abstract
Psychedelics are a hallucinogenic class of psychoactive drugs with the primary effect of activating non-ordinary states of consciousness. Due to the positive preliminary findings of these drugs in the treatment of psychiatric disorders, the number of registered clinical studies has risen significantly. In this paper, clinical studies registered on clinicaltrials.gov that evaluate the treatment of any psychiatric disorder with psychedelics (excluding ketamine) are summarized and analyzed. 70 registered studies were identified from a clinicaltrials.gov search on December 3, 2020. The majority of studies aim to investigate methylenedioxymethamphetamine (MDMA) (45.7%) and psilocybin (41.4%). Studies evaluating ayahuasca, lysergic acid diethylamide (LSD), ibogaine hydrochloride, salvia divinorum, 5-MeO-DMT and DMT fumarate were less common at 1.4%, 4.2%, 2.8%, 1.4%, 1.4% and 1.4% of total registered studies, respectively. Most of the studies on MDMA, psilocybin, ayahuasca and salvia divinorum investigated their therapeutic effect on post-traumatic stress disorder (PTSD) and major depressive disorder (MDD). LSD was investigated for MDD, anxiety, and severe somatic disorders and ibogaine hydrochloride was investigated for substance and alcohol use disorders. 5-MeO-DMT and DMT fumarate were both investigated for MDD. Only 21/70 registered studies had published results with the majority not yet completed. In view of the large number of ongoing studies investigating psychedelics, it is imperative that these studies are considered by researchers and stakeholders in deciding the most relevant research priorities for future proposed studies.
In the evidence
This study is part of the evidence base for 4 syntheses in the library. Here is how each one recorded it.
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As of December 2020, 70 registered trials studied psychedelics for psychiatric disorders, with ayahuasca among the less common agents and only 21 studies having published results.
Synthesized
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Only a small fraction of registered psychedelic trials involved DMT or 5-MeO-DMT (each about 1.4%), both targeting MDD, and only 21 of 70 registered studies had published results.
Synthesized
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As of December 2020, 70 registered trials investigated psychedelics for psychiatric disorders, with LSD studied for MDD, anxiety, and severe somatic disorders, but only 21 had published results.
Synthesized
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Reports that most registered psychedelic trials study MDMA or psilocybin for PTSD and depression, but only 21 of 70 had published results.
Synthesized
Comparable studies
Other narrative reviews on DMT for depression, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Role of Psychedelics in Treatment-Resistant Depression. | 2023 | Review | |
| Psilocybin and Other Classic Psychedelics in Depression. | 2024 | Review | |
| Benefits and Challenges of Ultra-Fast, Short-Acting Psychedelics in the Treatment of Depression | 2025 | Review | |
| Ayahuasca for the Treatment of Depression. | 2022 | Review | |
| A Brief Review on the Potential of Psychedelics for Treating Alzheimer’s Disease and Related Depression | 2023 | Review |
Citations in the library
Cited by 77
- Great Expectations: recommendations for improving the methodological rigor of psychedelic clinical trials Psychopharmacology April 1, 2022
- Adverse events in clinical treatments with serotonergic psychedelics and MDMA: A mixed-methods systematic review Journal of Psychopharmacology August 26, 2022
- Psychedelics and Other Psychoplastogens for Treating Mental Illness Frontiers in Psychiatry October 4, 2021
- The Watts Connectedness Scale: a new scale for measuring a sense of connectedness to self, others, and world Psychopharmacology August 8, 2022
- A non-hallucinogenic LSD analog with therapeutic potential for mood disorders. Cell Reports March 28, 2023
and 72 more in the library
Cites 15
- Psilocybin induces schizophrenia-like psychosis in humans via a serotonin-2 agonist action Neuroreport December 1, 1998
- The Therapeutic Potential of Psychedelic Drugs: Past, Present, and Future. Neuropsychopharmacology April 26, 2017
- Global Street Food: la cocina de la calle Diseño interior 2009
- Subjective Reports of the Effects of MDMA in a Clinical Setting Journal of Psychoactive Drugs October 1, 1986
- Psychiatry & the psychedelic drugs. Past, present & future. Neuropharmacology December 25, 2017
and 10 more in the library