Major Depressive Disorder (MDD)Depressive DisordersPTSDAnxiety DisordersAlcohol Use Disorder (AUD)Substance Use Disorders (SUD)MDMAPsilocybin

Registered clinical studies investigating psychedelic drugs for psychiatric disorders

This review (2021) summarizes the study characteristics of all ongoing registered clinical trials investigating psychedelic drugs for psychiatric disorders and identifies that their majority focuses on investigating MDMA and psilocybin for treating depression or PTSD, while only 30% of their results are published.

Authors

  • Roger McIntyre
  • Jonathan Rosenblat
  • Kayla Teopiz

Published

Journal of Psychiatric Research
meta Study

Abstract

Introduction

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.

Methods

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.

Results

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.

Discussion

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.

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Research Summary of 'Registered clinical studies investigating psychedelic drugs for psychiatric disorders'

Introduction

Psychedelics, often described as serotonergic hallucinogens, produce profound alterations in perception, mood and cognition via multiple serotonin-related mechanisms. The authors frame psychedelics as a heterogeneous group that includes classic 5-HT2A agonists (for example LSD, psilocybin, ayahuasca, DMT), empathogens/entactogens (MDMA), dissociative agents (NMDA antagonists, excluded here) and atypical hallucinogens (for example salvia divinorum, ibogaine). Interest in their therapeutic potential dates back to mid-20th century trials, but regulatory scheduling curtailed research until a recent resurgence. Contemporary studies have emphasised the use of psychedelics alongside psychotherapy, and early reports suggest promising efficacy and tolerability across conditions such as PTSD, major depressive disorder (MDD) and substance use disorders. Siegel and colleagues set out to systematically identify and describe all clinical studies registered on ClinicalTrials.gov that investigate psychedelic drugs (excluding ketamine) for psychiatric disorders. Rather than summarising published results, the analysis focused on registered trials—including ongoing and not-yet-completed studies—in order to map the research landscape, identify likely near-term evidence generation, and highlight gaps that warrant future attention.

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Study Details

References (14)

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Carhart-Harris, R. L., Goodwin, G. M. · Neuropsychopharmacology (2017)

Ayahuasca: pharmacology, neuroscience and therapeutic potential

Domínguez-Clavé, E., Soler, J., Elices, M. et al. · Brain Research Bulletin (2016)

The Emerging Role of Psilocybin and MDMA in the Treatment of Mental Illness

Gill, H., Gill, B., Chen-Li, D. et al. · Expert Review of Neurotherapeutics (2020)

The experimental effects of psilocybin on symptoms of anxiety and depression: A meta-analysis

Goldberg, S. B., Pace, B. T., Nicholas, C. R. et al. · Psychiatry Research (2020)

Subjective reports of the effects of MDMA in a clinical setting

Greer, G. R. · Journal of Psychoactive Drugs (1986)

423 cited
Show all 14 references
Psychedelic Drugs in Biomedicine

Kyzar, E. J., Nichols, C. D., Gainetdinov, R. R. et al. · Trends in Pharmacological Sciences (2017)

Psychedelics and Psychedelic-Assisted Psychotherapy

Reiff, C. M., Richman, E. E., Nemeroff, C. B. et al. · American Journal of Psychiatry (2020)

Psilocybin-Assisted Therapy: A Review of a Novel Treatment for Psychiatric Disorders

Thomas, K., Malcolm, B., Lastra, D. · Journal of Psychoactive Drugs (2017)

Psilocybin induces schizophrenia-like psychosis in humans via a serotonin-2 agonist action

Vollenweider, F. X., Vollenweider-Scherpenhuyzen, M. F. I., Bäbler, A. et al. · NeuroReport (1998)

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