Étiquette : essai clinique

Trial of Psilocybin versus Escitalopram for Depression, Robin Carhart-Harris et al., 2021

Trial of Psilocybin versus Escitalopram for Depression Robin Carhart-Harris, Ph.D., Bruna Giribaldi, B.Sc., Rosalind Watts, D.Clin.Psy., Michelle Baker-Jones, B.A., Ashleigh Murphy-Beiner, M.Sc., Roberta Murphy, M.D., Jonny Martell, M.D., Allan Blemings, M.Sc., David Erritzoe, M.D. and David J. Nutt, M.D.New England Journal of Medicine, 2021, 384, 1402-1411Doi : 10.1056/NEJMoa2032994 Abstract Background Psilocybin may have antidepressant properties, but direct comparisons between psilocybin and established treatments for depression are lacking. Methods In a phase 2, double-blind, randomized, controlled trial involving patients with long-standing, moderate-to-severe major depressive disorder, we compared psilocybin with escitalopram, a selective serotonin-reuptake inhibitor, over a 6-week period. Patients were assigned in a 1:1 ratio to receive [...]

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Psilocybin Delivers ‘Remarkable’ Relief in Severe Depression, Batya Swift Yasgur, Medscape.com, 2020

Psilocybin Delivers 'Remarkable' Relief in Severe Depression Batya Swift Yasgur, MA, LSW Medscape Medical News, November 05, 2020   Psilocybin, the psychedelic compound in "magic mushrooms," rapidly improves symptoms and produces remission in as little as two sessions for patients with major depression, new research suggests. Results of a small randomized trial showed that treatment with psilocybin was associated with a greater than 50% reduction in depressive symptoms in 67% of study participants. In addition, 71% showed improvement at 4-week follow-up, with more than 50% achieving remission. "The finding that the majority of people whom we treated showed efficacy was quite a remarkable and gratifying finding [...]

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Add-On Cannabidiol Treatment for Drug-Resistant Seizures in Tuberous Sclerosis Complex. A Placebo-Controlled Randomized Clinical Trial, Elizabeth A. Thiele et al., 2020

Add-On Cannabidiol Treatment for Drug-Resistant Seizures in Tuberous Sclerosis Complex. A Placebo-Controlled Randomized Clinical Trial Elizabeth A. Thiele, MD, PhD; E. Martina Bebin, MD, MPA; Hari Bhathal, MD; Floor E. Jansen, MD; Katarzyna Kotulska, MD, PhD; John A. Lawson, BMed, PhD; Finbar J. O'Callaghan, MBChB, PhD; MichaelWong,MD, PhD; Farhad Sahebkar, MD; Daniel Checketts, MSc; Volker Knappertz, MD; for the GWPCARE6 Study Group JAMA Neurology, 2020, December 21 online, E1-E7. doi : 10.1001/jamaneurol.2020.4607   IMPORTANCE : Efficacy of cannabidiol has been demonstrated in seizures associated with Lennox-Gastaut and Dravet syndromes but appears not yet to have been established in conditions with primarily focal seizures, such as [...]

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Psilocybin Delivers ‘Remarkable’ Relief in Severe Depression, Batya Swift Yasgur, 2020

Psilocybin Delivers 'Remarkable' Relief in Severe Depression Batya Swift Yasgur, MA, LSW Medscape.com, November 05, 2020   Psilocybin, the psychedelic compound in "magic mushrooms," rapidly improves symptoms and produces remission in as little as two sessions for patients with major depression, new research suggests. Results of a small randomized trial showed that treatment with psilocybin was associated with a greater than 50% reduction in depressive symptoms in 67% of study participants. In addition, 71% showed improvement at 4-week follow-up, with more than 50% achieving remission. "The finding that the majority of people whom we treated showed efficacy was quite a remarkable and gratifying finding and really sets the [...]

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Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder. A Randomized Clinical Trial, Alan K. Davis et al., 2020

Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder. A Randomized Clinical Trial Alan K. Davis, PhD; Frederick S. Barrett, PhD; Darrick G. May, MD; Mary P. Cosimano, MSW; Nathan D. Sepeda, BS; Matthew W. Johnson, PhD; Patrick H. Finan, PhD; Roland R. Griffiths, PhD JAMA Psychiatry, 2020, E1-E9. doi : 10.1001/jamapsychiatry.2020.3285   IMPORTANCE : Major depressive disorder (MDD) is a substantial public health burden, but current treatments have limited effectiveness and adherence. Recent evidence suggests that 1 or 2 administrations of psilocybin with psychological support produces antidepressant effects in patients with cancer and in those with treatment-resistant depression. OBJECTIVE : To investigate the effect of psilocybin [...]

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Reduction of Benzodiazepine Use in Patients Prescribed Medical Cannabis, Chad Purcell,

Reduction of Benzodiazepine Use in Patients Prescribed Medical Cannabis Chad Purcell, Andrew Davis, Nico Moolman, and S. Mark Taylor Cannabis and Cannabinoid Research, 2019, Volume 4, Number 3, Doi : 10.1089/can.2018.0020   Abstract Background : Benzodiazepines are a class of medication with sedative properties, commonly used for anxiety and other neurological conditions. These medications are associated with several well-known adverse effects. This observational study aims to investigate the reduction of benzodiazepine use in patients using prescribed medical cannabis. Methods : A retrospective analysis was performed on a cohort of 146 medical cannabis patients (average age 47 years, 61% female, 54% reporting prior use of cannabis) who reported [...]

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FDA Okays New Indication for Esketamine Nasal Spray, Megan Brooks, Medscape – Aug 03, 2020.

FDA Okays New Indication for Esketamine Nasal Spray Megan Brooks Medscape - Aug 03, 2020. The US Food and Drug Administration (FDA) has approved the supplemental new drug application for esketamine nasal spray (Spravato, Janssen Pharmaceuticals) to treat depressive symptoms in adults with major depressive disorder (MDD) and acute suicidal ideation or behavior. The FDA approved esketamine nasal spray for treatment-resistant depression in March 2019, as reported by Medscape Medical News. The new indication is based on data from two identical phase 3 trials — ASPIRE I and ASPIRE II — which evaluated the efficacy and safety of the nasal spray in addition to a comprehensive standard of care [...]

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Cannabidiol for the treatment of cannabis use disorder : a phase 2a, double-blind, placebo-controlled, randomised, adaptive Bayesian trial, Tom P. Freeman et al., 2020

Cannabidiol for the treatment of cannabis use disorder : a phase 2a, double-blind, placebo-controlled, randomised, adaptive Bayesian trial Tom P Freeman, Chandni Hindocha, Gianluca Baio, Natacha D C Shaban, Emily M Thomas, Danica Astbury, Abigail M Freeman, Rachel Lees, Sam Craft, Paul D Morrison, Michael A P Bloomfield, Dominic O'Ryan, Jane Kinghorn, Celia J A Morgan, Ali Mofeez, H Valerie Curran The Lancet Psychiatry, 2020, doi : 10.1016/S2215-0366(20)30290-X  Abstract Background : A substantial and unmet clinical need exists for pharmacological treatment of cannabis use disorders. Cannabidiol could offer a novel treatment, but it is unclear which doses might be efficacious or safe. Therefore, we aimed to identify efficacious doses and eliminate inefficacious doses in a phase 2a trial using [...]

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A low dose of lysergic acid diethylamide decreases pain perception in healthy volunteers, Johannes G. Ramaekers et al., 2020,

A low dose of lysergic acid diethylamide decreases pain perception in healthy volunteers Johannes G. Ramaekers, Nadia Hutten, Natasha L. Mason, Patrick Dolder1, Eef L. Theunissen, Friederike Holze, Matthias E. Liechti, Amanda Feilding and Kim P.C. Kuypers Journal of Psychopharmacology, 2020, 1–8. doi : 10.1177/026988112094093   Abstract Background : Lysergic acid diethylamide (LSD) is an ergot alkaloid derivative with psychedelic properties that has been implicated in the management of persistent pain. Clinical studies in the 1960s and 1970s have demonstrated profound analgesic effects of full doses of LSD in terminally ill patients, but this line of research evaporated after LSD was scheduled worldwide. Aim : The present [...]

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Does cannabidiol reduce severe behavioural problems in children with intellectual disability? Study protocol for a pilot single-site phase I/II randomised placebo controlled trial, Daryl Efron et al.,

Does cannabidiol reduce severe behavioural problems in children with intellectual disability? Study protocol for a pilot single-site phase I/II randomised placebo controlled trial Daryl Efron, Kaitlyn Taylor, Jonathan M Payne, Jeremy L Freeman, Noel Cranswick, Melissa Mulraney, Chidambaram Prakash, Katherine J Lee, Katrina Williams BMJ Open, 2020, 10, e034362. doi : 10.1136/bmjopen-2019-034362   Abstract Introduction : Severe behavioural problems (SBPs) are a common contributor to morbidity and reduced quality of life in children with intellectual disability (ID). Current medication treatment for SBP is associated with a high risk of side effects. Innovative and safe interventions are urgently needed. Anecdotal reports and preliminary research suggest that medicinal [...]

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