FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4386305655> ?p ?o ?g. }

• W4386305655 endingPage "843" @default.
• W4386305655 startingPage "843" @default.
• W4386305655 abstract "Psilocybin shows promise as a treatment for major depressive disorder (MDD).To evaluate the magnitude, timing, and durability of antidepressant effects and safety of a single dose of psilocybin in patients with MDD.In this phase 2 trial conducted between December 2019 and June 2022 at 11 research sites in the US, participants were randomized in a 1:1 ratio to receive a single dose of psilocybin vs niacin placebo administered with psychological support. Participants were adults aged 21 to 65 years with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of MDD of at least 60 days' duration and moderate or greater symptom severity. Exclusion criteria included history of psychosis or mania, active substance use disorder, and active suicidal ideation with intent. Participants taking psychotropic agents who otherwise met inclusion/exclusion criteria were eligible following medication taper. Primary and secondary outcomes and adverse events (AEs) were assessed at baseline (conducted within 7 days before dosing) and at 2, 8, 15, 29, and 43 days after dosing.Interventions were a 25-mg dose of synthetic psilocybin or a 100-mg dose of niacin in identical-appearing capsules, each administered with psychological support.The primary outcome was change in central rater-assessed Montgomery-Asberg Depression Rating Scale (MADRS) score (range, 0-60; higher scores indicate more severe depression) from baseline to day 43. The key secondary outcome measure was change in MADRS score from baseline to day 8. Other secondary outcomes were change in Sheehan Disability Scale score from baseline to day 43 and MADRS-defined sustained response and remission. Participants, study site personnel, study sponsor, outcome assessors (raters), and statisticians were blinded to treatment assignment.A total of 104 participants (mean [SD] age, 41.1 [11.3] years; 52 [50%] women) were randomized (51 to the psilocybin group and 53 to the niacin group). Psilocybin treatment was associated with significantly reduced MADRS scores compared with niacin from baseline to day 43 (mean difference,-12.3 [95% CI, -17.5 to -7.2]; P <.001) and from baseline to day 8 (mean difference, -12.0 [95% CI, -16.6 to -7.4]; P < .001). Psilocybin treatment was also associated with significantly reduced Sheehan Disability Scale scores compared with niacin (mean difference, -2.31 [95% CI, 3.50-1.11]; P < .001) from baseline to day 43. More participants receiving psilocybin had sustained response (but not remission) than those receiving niacin. There were no serious treatment-emergent AEs; however, psilocybin treatment was associated with a higher rate of overall AEs and a higher rate of severe AEs.Psilocybin treatment was associated with a clinically significant sustained reduction in depressive symptoms and functional disability, without serious adverse events. These findings add to increasing evidence that psilocybin-when administered with psychological support-may hold promise as a novel intervention for MDD.ClinicalTrials.gov Identifier: NCT03866174." @default.
• W4386305655 created "2023-09-01" @default.
• W4386305655 creator A5002583244 @default.
• W4386305655 creator A5007445878 @default.
• W4386305655 creator A5017664220 @default.
• W4386305655 creator A5023606467 @default.
• W4386305655 creator A5024428296 @default.
• W4386305655 creator A5024726266 @default.
• W4386305655 creator A5031084453 @default.
• W4386305655 creator A5033314729 @default.
• W4386305655 creator A5035621912 @default.
• W4386305655 creator A5037185919 @default.
• W4386305655 creator A5040929530 @default.
• W4386305655 creator A5042151214 @default.
• W4386305655 creator A5043044020 @default.
• W4386305655 creator A5043376293 @default.
• W4386305655 creator A5043428133 @default.
• W4386305655 creator A5048292874 @default.
• W4386305655 creator A5053850619 @default.
• W4386305655 creator A5056637382 @default.
• W4386305655 creator A5062642094 @default.
• W4386305655 creator A5066155034 @default.
• W4386305655 creator A5067232235 @default.
• W4386305655 creator A5067326521 @default.
• W4386305655 creator A5067531163 @default.
• W4386305655 creator A5068139431 @default.
• W4386305655 creator A5075166971 @default.
• W4386305655 creator A5080146983 @default.
• W4386305655 creator A5081129089 @default.
• W4386305655 creator A5082935636 @default.
• W4386305655 creator A5088507656 @default.
• W4386305655 creator A5091298782 @default.
• W4386305655 creator A5092721397 @default.
• W4386305655 creator A5092721398 @default.
• W4386305655 creator A5092721399 @default.
• W4386305655 creator A5092721400 @default.
• W4386305655 date "2023-09-05" @default.
• W4386305655 modified "2023-10-09" @default.
• W4386305655 title "Single-Dose Psilocybin Treatment for Major Depressive Disorder" @default.
• W4386305655 cites W1993810702 @default.
• W4386305655 cites W2034147634 @default.
• W4386305655 cites W2113099805 @default.
• W4386305655 cites W2131823335 @default.
• W4386305655 cites W2156458337 @default.
• W4386305655 cites W2161555895 @default.
• W4386305655 cites W2168253623 @default.
• W4386305655 cites W2396675581 @default.
• W4386305655 cites W2558412547 @default.
• W4386305655 cites W2559739670 @default.
• W4386305655 cites W2767530231 @default.
• W4386305655 cites W2887938296 @default.
• W4386305655 cites W2965468106 @default.
• W4386305655 cites W3000636165 @default.
• W4386305655 cites W3096208965 @default.
• W4386305655 cites W3129586996 @default.
• W4386305655 cites W3156937150 @default.
• W4386305655 cites W3200483052 @default.
• W4386305655 cites W4212903385 @default.
• W4386305655 cites W4224223934 @default.
• W4386305655 cites W4226207502 @default.
• W4386305655 cites W4226459778 @default.
• W4386305655 cites W4237965053 @default.
• W4386305655 cites W4243089545 @default.
• W4386305655 cites W4292937262 @default.
• W4386305655 cites W4293194637 @default.
• W4386305655 cites W4293801859 @default.
• W4386305655 cites W4306780560 @default.
• W4386305655 cites W4308146982 @default.
• W4386305655 cites W4309328263 @default.
• W4386305655 cites W4313530670 @default.
• W4386305655 cites W4361301344 @default.
• W4386305655 doi "https://doi.org/10.1001/jama.2023.14530" @default.
• W4386305655 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/37651119" @default.
• W4386305655 hasPublicationYear "2023" @default.
• W4386305655 type Work @default.
• W4386305655 citedByCount "4" @default.
• W4386305655 countsByYear W43863056552023 @default.
• W4386305655 crossrefType "journal-article" @default.
• W4386305655 hasAuthorship W4386305655A5002583244 @default.
• W4386305655 hasAuthorship W4386305655A5007445878 @default.
• W4386305655 hasAuthorship W4386305655A5017664220 @default.
• W4386305655 hasAuthorship W4386305655A5023606467 @default.
• W4386305655 hasAuthorship W4386305655A5024428296 @default.
• W4386305655 hasAuthorship W4386305655A5024726266 @default.
• W4386305655 hasAuthorship W4386305655A5031084453 @default.
• W4386305655 hasAuthorship W4386305655A5033314729 @default.
• W4386305655 hasAuthorship W4386305655A5035621912 @default.
• W4386305655 hasAuthorship W4386305655A5037185919 @default.
• W4386305655 hasAuthorship W4386305655A5040929530 @default.
• W4386305655 hasAuthorship W4386305655A5042151214 @default.
• W4386305655 hasAuthorship W4386305655A5043044020 @default.
• W4386305655 hasAuthorship W4386305655A5043376293 @default.
• W4386305655 hasAuthorship W4386305655A5043428133 @default.
• W4386305655 hasAuthorship W4386305655A5048292874 @default.
• W4386305655 hasAuthorship W4386305655A5053850619 @default.
• W4386305655 hasAuthorship W4386305655A5056637382 @default.
• W4386305655 hasAuthorship W4386305655A5062642094 @default.
• W4386305655 hasAuthorship W4386305655A5066155034 @default.

• next