Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression

Goodwin, Guy M.; Aaronson, Scott T.; Alvarez, Oscar; Arden, Peter C.; Baker, Annie; Bennett, James; Bird, Catherine; Blom, Renske E.; Brennan, Christine; Brusch, Donna; Burke, Lisa; Campbell-Coker, Kete; Carhart‐Harris, Robin; Cattell, Joseph; Daniel, Aster; DeBattista, Charles; Dunlop, Boadie W.; Eisen, Katherine E.; Feifel, David; Forbes, MacKenzie; Haumann, Hannah M.; Hellerstein, David J.; Hoppe, Astrid I.; Husain, Muhammad Ishrat; Jelen, Luke A.; Kamphuis, Jeanine; Kawasaki, Julie; Kelly, John R.; Key, Richard E.; Kishon, Ronit; Peck, Stephanie Knatz; Knight, Gemma; Koolen, Martijn H.B.; Lean, Melanie; Licht, Rasmus W; Maples‐Keller, Jessica L.; Mars, Jan; Marwood, Lindsey; McElhiney, Martin; Miller, Tammy L.; Mirow, Arvin; Mistry, S.; Mletzko-Crowe, Tanja; Modlin, Liam N.; Nielsen, René Ernst; Nielson, Elizabeth M.; Offerhaus, Sjoerd R.; O’Keane, Veronica; Páleníček, Tomáš; Printz, David; Rademaker, Marleen C.; Reemst, Aumer van; Reinholdt, Frederick; Repantis, Dimitris; Rucker, James; Rudow, Samuel; Ruffell, Simon; Rush, A. John; Schoevers, Robert A.; Seynaeve, Mathieu; Shao, Samantha; Soares, Jair C.; Somers, Metten; Stansfield, Susan C.; Sterling, Diane; Strockis, Aaron; Tsai, Joyce; Visser, Lucy; Wahba, Mourad; Williams, Samuel P; Young, Allan H.; Ywema, Paula; Zisook, Sidney; Malievskaia, Ekaterina

doi:10.1056/nejmoa2206443

Cited by 437 publications

(390 citation statements)

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“…A recent phase 2 double-blind trial of single-dose psilocybin (1 mg, 10 mg, and 25 mg) for treatment-resistant depression (N = 233) sheds more light on the risk of adverse effects. 13 The percentage of individuals experiencing adverse effects on Day 1 of administration was high: 61% in the 25 mg psilocybin group. Headache, nausea, fatigue, and dizziness were the most common effects.…”

Section: (Page 18)mentioning

confidence: 96%

“…The high incidence of adverse effects and suicidality noted in the recent phase 2 trial of psilocybin in treatment resistant depression are a reminder of this. 13 There is uncertainty regarding the magnitude of risk in real-world clinical practice, particularly regarding addiction, suicidality, and precipitation or worsening of psychotic disorders. For example, note the extensive exclusion criteria used in the psilocybin vs escitalopram RCT by Carhart-Harris et al 12 : currently or previously diagnosed psychotic disorder, immediate family member with a diagnosed psychotic disorder, significant medical comorbidity (eg, diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure), history of suicide attempts requiring hospitalization, history of mania, pregnancy, and abnormal QT interval prolongation, among others.…”

Section: Mdedgecom/psychiatrymentioning

confidence: 99%

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Psychedelics for treating psychiatric disorders: Are they safe?

Thakur¹

2022

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P sychedelics are a class of substances known to produce alterations in consciousness and perception. In the last 2 decades, psychedelic research has garnered increasing attention from scientists, therapists, entrepreneurs, and the public. While many of these compounds remain illegal in the United States and in many parts of the world (Box, 1 page 16), a recent resurrection of psychedelic research has motivated the FDA to designate multiple psychedelic compounds as "breakthrough therapies," thereby expediting the investigation, development, and review of psychedelic treatments.There is growing evidence that psychedelics may be efficacious for treating a range of psychiatric disorders. Potential clinical indications for psychedelics include some forms of depression, posttraumatic stress disorder (PTSD), and substance use disorders (Table 1, 2,3 page 17). In most instances, the clinical use of psychedelics is being investigated and offered in the context of psychedelic-assisted psychotherapy, though ketamine is a prominent exception. Ketamine and esketamine are already being used to treat depression, and FDA approval is anticipated for other psychedelics. An examination of the safety considerations of psychedelics for the treatment of psychiatric disorders is therefore highly relevant and timely.This article examines the adverse effect profile of classical (psilocybin ["mushrooms"], lysergic acid diethylamide [LSD], and N,N-dimethyltryptamine [DMT]/ayahuasca) and nonclassical (the entactogen 3,4-methylenedioxymethamphetamine [MDMA, known as "ecstasy"] and the dissociative anesthetic ketamine) psychedelics.

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Section: (Page 18)mentioning

confidence: 96%

Section: Mdedgecom/psychiatrymentioning

confidence: 99%

Psychedelics for treating psychiatric disorders: Are they safe?

Thakur¹

2022

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“…A single 25 mg dose of psilocybin, the active ingredient in magic mushrooms, has a significant effect on reducing symptoms of depression in people who have so far not benefited from treatment, trial results have shown 1…”

mentioning

confidence: 99%

“…The results of the study, published in the New England Journal of Medicine ,1 showed that participants reported a rapid and greater reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS) three weeks after taking a single 25 mg dose than those who took the 1 mg dose (P<0.001).…”

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confidence: 99%

Psilocybin reduces symptoms in treatment resistant depression, trial results show

Iacobucci¹

2022

BMJ

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“…Small modern trials have shown that ayahuasca and psilocybin have promising antidepressant and anxiolytic effects on patients with major depressive disorder [5][6][7][8] or on those showing depressive and anxious symptoms associated with cancer or other life-threatening diseases [9,10], as well as in substance use disorders [11]. Remarkably, these drugs induced significant reductions in depressive and anxiety symptoms within hours/days, and the beneficial effects were sustained for weeks to months.…”

mentioning

confidence: 99%