Psilocybin for depression

Considerations for clinical trial design

Bibliographic Data

ID4722500
AuthorsKelley C O’donnell (0000-0001-9983-2699, Bellevue Hospital Center, corresponding author), Sarah E Mennenga (Bellevue Hospital Center), Michael P Bogenschutz (0000-0003-4530-3470, New York University)
Year2019
Volume3
Issue3
Pages269-279
Publication date2019-09-19
Peer ReviewedYes
Open AccessYes
TypeARTICLE
VenueJournal of Psychedelic Studies (JOURNAL)
Journal identifiersISSN: 2559-9283 • E-ISSN: 2559-9283
PublisherAkademiai Kiado Zrt (PUBLISHER)
DOI10.1556/2054.2019.026
OpenAlexW2974814938
LanguageEN
Citations received1
References cited69

Background and aims Given the enormous global burden of depressive illness, there is an urgent need to develop novel and more effective treatments for major depressive disorder (MDD). Recent findings have suggested that psychedelic drugs may have a role in the treatment of depressive symptoms, and a number of groups are in the process of developing protocols to study this question systematically. Given the subjective quality of both the psychedelic experience and depressive symptomatology, great care must be taken when designing a protocol to study the clinical efficacy of psychedelic drugs. This study will discuss many factors to consider when designing a clinical trial of psilocybin for MDD. Methods We provide a thorough review of pertinent research into antidepressant clinical trial methodology and review practical considerations that are relevant to the study of psychedelic-assisted treatment for depression. Results We discuss participant selection (including diagnostic accuracy, exclusion criteria, characteristics of the depressive episode, and the use of concurrent medications), study interventions (including dosing regimens, placebo selection, non-pharmacological components of treatment, and the importance of blinding), trial duration, outcome measures, and safety considerations. Conclusions Careful and transparent study design and data analysis will maximize the likelihood of generating meaningful, reproducible results, and identifying a treatment-specific effect. Meeting the highest standards for contemporary trial design may also broaden the acceptance of psychedelic research in the scientific community at large

Alternative medicine · Antidepressant · Anxiety · Blinding · Clinical study design · Clinical trial · Cognition · Hallucinogen · Major depressive disorder · Psilocybin · Psychiatry · Psychological intervention · Research design · Chemical synthesis and alkaloids · Clinical Psychology · Medicine · Neurotransmitter Receptor Influence on Behavior · Psychedelics and Drug Studies · Psychology

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