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  1. Article ; Online: Antidepressant Effects of Psilocybin in the Absence of Psychedelic Effects.

    Rosenblat, Joshua D / Leon-Carlyle, Marisa / Ali, Shaun / Husain, M Ishrat / McIntyre, Roger S

    The American journal of psychiatry

    2023  Volume 180, Issue 5, Page(s) 395–396

    MeSH term(s) Humans ; Hallucinogens/pharmacology ; Hallucinogens/therapeutic use ; Psilocybin/pharmacology ; Psilocybin/therapeutic use ; Lysergic Acid Diethylamide ; Antidepressive Agents/pharmacology ; Antidepressive Agents/therapeutic use
    Chemical Substances Hallucinogens ; Psilocybin (2RV7212BP0) ; Lysergic Acid Diethylamide (8NA5SWF92O) ; Antidepressive Agents
    Language English
    Publishing date 2023-03-22
    Publishing country United States
    Document type Letter
    ZDB-ID 280045-7
    ISSN 1535-7228 ; 0002-953X
    ISSN (online) 1535-7228
    ISSN 0002-953X
    DOI 10.1176/appi.ajp.20220835
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Psilocybin-assisted psychotherapy for treatment resistant depression: A randomized clinical trial evaluating repeated doses of psilocybin.

    Rosenblat, Joshua D / Meshkat, Shakila / Doyle, Zoe / Kaczmarek, Erica / Brudner, Ryan M / Kratiuk, Kevin / Mansur, Rodrigo B / Schulz-Quach, Christian / Sethi, Rickinder / Abate, Amanda / Ali, Shaun / Bawks, Jordan / Blainey, Marc G / Brietzke, Elisa / Cronin, Victoria / Danilewitz, Jessica / Dhawan, Shalini / Di Fonzo, Anthony / Di Fonzo, Melissa /
    Drzadzewski, Pawel / Dunlop, William / Fiszter, Hajnalka / Gomes, Fabiano A / Grewal, Smrita / Leon-Carlyle, Marisa / McCallum, Marilyn / Mofidi, Niki / Offman, Hilary / Riva-Cambrin, Jeremy / Schmidt, Joel / Smolkin, Mark / Quinn, Joan M / Zumrova, Andrea / Marlborough, Michelle / McIntyre, Roger S

    Med (New York, N.Y.)

    2024  Volume 5, Issue 3, Page(s) 190–200.e5

    Abstract: Background: Psilocybin-assisted psychotherapy (PAP) has been associated with antidepressant effects. Trials to date have typically excluded participants with complex presentations. Our aim was to determine the feasibility of PAP in a complex population, ...

    Abstract Background: Psilocybin-assisted psychotherapy (PAP) has been associated with antidepressant effects. Trials to date have typically excluded participants with complex presentations. Our aim was to determine the feasibility of PAP in a complex population, including high levels of treatment resistance in major depressive and bipolar disorder and patients with baseline suicidality and significant comorbidity. We also evaluated flexible repeated doses over a 6-month period.
    Methods: Adults with treatment-resistant depression as part of major depressive or bipolar II disorder without psychosis or a substance use disorder were eligible to participate. Subjects were randomized to immediate treatment or waitlist control, with all eventually receiving PAP. Participants had one, two, or three psilocybin sessions with a fixed dose of 25 mg. Each dose was accompanied by preparation and integration psychotherapy sessions. Acceptability, safety, tolerability, and efficacy were evaluated (this study was registered at ClinicalTrials.gov: NCT05029466).
    Findings: Participants were randomized to immediate treatment (n = 16) or delayed treatment (n = 14). 29/30 were retained to the week-2 primary endpoint. Adverse events were transient, with no serious adverse events. Greater reductions in depression severity as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) were observed in the immediate treatment arm compared to the waitlist period arm with a large hedge's g effect size of 1.07 (p < 0.01). Repeated doses were associated with further reductions in MADRS scores compared to baseline.
    Conclusions: PAP was feasible in complex patients with preliminary antidepressant efficacy and adequate safety and tolerability. Repeated doses were associated with greater reductions in depression severity.
    Funding: This work was funded by Brain and Cognition Discovery Foundation (BCDF), Usona, and Braxia Scientific.
    MeSH term(s) Adult ; Humans ; Psilocybin/adverse effects ; Depressive Disorder, Major/drug therapy ; Depressive Disorder, Major/chemically induced ; Depressive Disorder, Treatment-Resistant/drug therapy ; Antidepressive Agents/adverse effects ; Psychotherapy
    Chemical Substances Psilocybin (2RV7212BP0) ; Antidepressive Agents
    Language English
    Publishing date 2024-02-14
    Publishing country United States
    Document type Randomized Controlled Trial ; Journal Article
    ISSN 2666-6340
    ISSN (online) 2666-6340
    DOI 10.1016/j.medj.2024.01.005
    Database MEDical Literature Analysis and Retrieval System OnLINE

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