Catégorie : Essais Cliniques

Intranasal Ketamine Succeeds for Resistant Depression in Phase 3 Trial, Deborah BrauserMay 11, 2018

Intranasal Ketamine Succeeds for Resistant Depression in Phase 3 Trial Deborah Brauser May 11, 2018 https://www.medscape.com/viewarticle/896510 NEW YORK — Administering intranasal esketamine (Janssen) plus an antidepressant is safe, effective, and well tolerated in adult patients with treatment-resistant depression (TRD), a new phase 3 trial suggests. Dr Vanina Popova In the global study, those who received a newly initiated oral antidepressant combined with esketamine nasal spray (56 or 84 mg) showed a 4-point greater improvement from baseline to 4 weeks on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score than those who received an antidepressant plus placebo, meeting the study's primary endpoint. In addition, the response rate was nearly 70% [...]

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3,4-Methylenedioxymethamphetamine assisted psychotherapy for treatment of chronic posttraumatic stress disorder : A randomized phase 2 controlled trial, Marcela Ot’alora G et al., 2018

3,4-Methylenedioxymethamphetamine assisted psychotherapy for treatment of chronic posttraumatic stress disorder : A randomized phase 2 controlled trial Marcela Ot’alora G, Jim Grigsby, Bruce Poulter1, Joseph W Van Derveer III3, Sara Gael Giron, Lisa Jerome, Allison A Feduccia, Scott Hamilton6, Berra Yazar-Klosinski, Amy Emerson, Michael C Mithoefer and Rick Doblin Journal of Psychopharmacology, 2018, 1-13 DOI: 10.1177/0269881118806297 Abstract Background : Posttraumatic stress disorder often does not resolve after conventional psychotherapies or pharmacotherapies. Pilot studies have reported that 3,4-methylenedioxymethamphetamine (MDMA) combined with psychotherapy reduces posttraumatic stress disorder symptoms. Aims : This pilot dose response trial assessed efficacy and safety of MDMA-assisted psychotherapy across multiple therapy teams. Methods : Twenty-eight [...]

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Chapter : The endocannabinoid system in Fragile X Syndrome, Henry G. S. Martin et al., 2017

Chapter : The endocannabinoid system in Fragile X Syndrome Henry G. S. Martin, Daniela Neuhofer and Olivier J.J. Manzoni Fragile X Syndrome : From Genetics to Targeted Treatment, 2017, Pages 241-259 DOI: 10.1016/B978-0-12-804461-2.00012-3 Addresses: INSERM U901, INMED and UMR S901, Aix-Marseille University Marseille 13009, France. Abstract : Endocannabinoid signaling is a finely tuned system of molecules and lipid messengers that modulate neurotransmission in a rapid and sustained manner at many central synapses. The endocannabinoid system is important for many brain activities, but is also implicated in several neuropsychiatric disorders. In this chapter we discuss emerging evidence of dysfunction in endocannabinoid signaling in Fragile X Syndrome from the Fmr1 knockout mouse model. [...]

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Overcoming the Bell‐Shaped Dose‐Response of Cannabidiol by Using Cannabis Extract Enriched in Cannabidiol, Ruth Gallily et al.,

Overcoming the Bell‐Shaped Dose‐Response of Cannabidiol by Using Cannabis Extract Enriched in Cannabidiol Ruth Gallily, Zhannah Yekhtin, Lumír Ondřej Hanuš Pharmacology & Pharmacy, 2015, 6, 75-85 http://dx.doi.org/10.4236/pp.2015.62010 Abstract : Cannabidiol (CBD), a major constituent of Cannabis, has been shown to be a powerful anti inflammatory and anti‐anxiety drug, without exerting a psychotropic effect. However, when given either intraperitoneally or orally as a purified product, a bell‐shaped dose‐response was observed, which limits its clinical use. In the present study, we have studied in mice the anti‐inflammatory and anti nociceptive activities of standardized plant extracts derived from the Cannabis sativa L., clone 202, which is highly enriched [...]

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A Phase I, Randomized, Double‑Blind, Placebo‑Controlled, Single Ascending Dose, Multiple Dose, and Food Effect Trial of the Safety, Tolerability and Pharmacokinetics of Highly Purified Cannabidiol in Healthy Subjects, Lesley Taylor et al., 2018

A Phase I, Randomized, Double‑Blind, Placebo‑Controlled, Single Ascending Dose, Multiple Dose, and Food Effect Trial of the Safety, Tolerability and Pharmacokinetics of Highly Purified Cannabidiol in Healthy Subjects Lesley Taylor,·Barry Gidal,·Graham Blakey, Bola Tayo, Gilmour Morrison CNS Drugs, 2018 https://doi.org/10.1007/s40263-018-0578-5 Abstract Background : A formal single ascending and multiple dose pharmacokinetic (PK) trial of cannabidiol (CBD) oral solution was required to determine the safety and tolerability of CBD, the maximum tolerated dose, and to examine the effect of food on CBD PK parameters. Objective : This trial assessed the safety, tolerability and PK of CBD oral solution in healthy adult volunteers, as well as the effect [...]

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Cannabidiol as a Novel Candidate Alcohol Use Disorder Pharmacotherapy : A Systematic Review, Jasmine Turna et al., 2019

Cannabidiol as a Novel Candidate Alcohol Use Disorder Pharmacotherapy : A Systematic Review Jasmine Turna, Sabrina K. Syan, Benicio N. Frey, Brian Rush, Mary Jean Costello, Mark Weiss, and James MacKillop ALCOHOLISM: CLINICAL AND EXPERIMENTAL RESEARCH, 2019, 1-14   Abstract : There is substantial interest in the therapeutic potential of cannabidiol (CBD), a nonpsychoactive cannabinoid found in plants of the genus Cannabis. The goal of the current systematic review was to characterize the existing literature on this topic and to evaluate the credibility of CBD as a candidate pharmacotherapy for alcohol use disorder (AUD). Using a comprehensive search strategy, 303 unique potential articles were identified [...]

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Descriptive Psychopathology of the Acute Effects of Intravenous Delta-9-Tetrahydrocannabinol Administration in Humans, Marco Colizzi et al., 2019

Descriptive Psychopathology of the Acute Effects of Intravenous Delta-9-Tetrahydrocannabinol Administration in Humans Marco Colizzi, NathalieWeltens, Philip McGuire, Lukas Van Oudenhove and Sagnik Bhattacharyya Brain Sciences, 2019, 9, 93 doi:10.3390/brainsci9040093 Abstract : Background : Cannabis use can increase the risk of psychosis, and the acute administration of its key psychoactive ingredient, delta-9-tetrahydrocannabinol (D9-THC), can induce transient psychotomimetic symptoms. Methods: A double-blind, randomized, placebo-controlled crossover design was used to investigate the symptomatic eects of acute intravenous administration of D9-THC (1.19 mg/2 mL) in 16 healthy participants (seven males) with modest previous cannabis exposure. Results : In the 20 min following acute D9-THC administration, symptomatic eects of at [...]

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The effects of cannabidiol on impulsivity and memory during abstinence in cigarette dependent smokers, C. Hindocha et al., 2018

The effects of cannabidiol on impulsivity and memory during abstinence in cigarette dependent smokers C. Hindocha, T. P. Freeman, M. Grabski, H. Crudgington, A. C. Davies, J. B. Stroud, R. K. Das, W. Lawn, C. J. A. Morgan & H. V. Curran Scientific Reports, 2018, 8, 7568 DOI:10.1038/s41598-018-25846-2 Abstract : Acute nicotine abstinence in cigarette smokers results in deficits in performance on specific cognitive processes, including working memory and impulsivity which are important in relapse. Cannabidiol (CBD), the non-intoxicating cannabinoid found in cannabis, has shown pro-cognitive effects and preliminary evidence has indicated it can reduce the number of cigarettes smoked in dependent smokers. However, the effects [...]

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New Therapy for Treatment-Resistant Depression, Feyza Sancar, JAMA, 2019,

New Therapy for Treatment-Resistant Depression Feyza Sancar JAMA, 2019, 321, 15, 1449. doi:10.1001/jama.2019.3596 https://jamanetwork.com/journals/jama/fullarticle/2730598   The FDA has approved esketamine nasal spray as an adjunctive therapy for adults with treatment-resistant depression (TRD), which affects approximately 30% of patients with major depressivedisorder. It’s the first regulatory approval of esketamine, the s-enantiomer of ketamine, for any psychiatric condition worldwide. “There has been a long-standing need for additional effective treatments for treatment resistant depression, a serious and lifethreateningcondition,” Tiffany Farchione,MD, acting director of the FDA’s Division of Psychiatry Products, said in a statement. Marketed as Spravato, the drug is indicated for patients whose depressive symptoms haven’t improved [...]

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Effects of Cannabis Use on Sedation Requirements for Endoscopic Procedures, Mark A. Twardowski et al., 2019

Effects of Cannabis Use on Sedation Requirements for Endoscopic Procedures Mark A. Twardowski, Margaret M. Link,  Nicole M. Twardowski The Journal of the American Osteopathic Association, 2019 (Published online April 15, 2019). doi:10.7556/jaoa.2019.052   Context : Cannabis (or marijuana) became legal for recreational use in Colorado in 2012, and this legislation change has created both challenges and opportunities in medicine. More patients are using cannabis, and more patients are now willing to admit cannabis use than in the past, which increases the likelihood that they will be forthcoming about use during medical questioning. Cannabis use may have implications during medical care, including procedural sedation. Objective : [...]

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