Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression.
| Title: | Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. |
|---|---|
| Authors: | Goodwin, Guy M; Aaronson, Scott T; Alvarez, Oscar; Arden, Peter C; Baker, Annie; Bennett, James C; 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; Feifel, David; Forbes, MacKenzie; Haumann, Hannah M; Hellerstein, David J; Hoppe, Astrid I; Husain, Muhammad I; Jelen, Luke A; Kamphuis, Jeanine; Kawasaki, Julie; Kelly, John R; Key, Richard E; Kishon, Ronit; Knatz Peck, Stephanie; Knight, Gemma; Koolen, Martijn H B; Lean, Melanie; Licht, Rasmus W.; Maples-Keller, Jessica L; Mars, Jan; Marwood, Lindsey; McElhiney, Martin C; Miller, Tammy L; Mirow, Arvin; Mistry, Sunil; Mletzko-Crowe, Tanja; Modlin, Liam N; Nielsen, René E.; Nielson, Elizabeth M; Offerhaus, Sjoerd R; O'Keane, Veronica; Páleníček, Tomáš; Printz, David; Rademaker, Marleen C; van Reemst, Aumer; 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; Young, Allan H; Ywema, Paula; Zisook, Sidney; Malievskaia, Ekaterina |
| Source: | Goodwin, G M, Aaronson, S T, Alvarez, O, Arden, P C, Baker, A, Bennett, J C, Bird, C, Blom, R E, Brennan, C, Brusch, D, Burke, L, Campbell-Coker, K, Carhart-Harris, R, Cattell, J, Daniel, A, DeBattista, C, Dunlop, B W, Eisen, K, Feifel, D, Forbes, M, Haumann, H M, Hellerstein, D J, Hoppe, A I, Husain, M I, Jelen, L A, Kamphuis, J, Kawasaki, J, Kelly, J R, Key, R E, Kishon, R, Knatz Peck, S, Knight, G, Koolen, M H B, Lean, M, Licht, R W, Maples-Keller, J L, Mars, J, Marwood, L, McElhiney, M C, Miller, T .... |
| Publication Year: | 2022 |
| Collection: | Aalborg University (AAU): Publications / Aalborg Universitet: Publikationer |
| Subject Terms: | Adult; Antidepressive Agents; Depression; Depressive Disorder; Major; Treatment-Resistant; Double-Blind Method; Humans; Psilocybin; Treatment Outcome; adverse effects; drug therapy; psychology; therapeutic use |
| Description: | BACKGROUND: Psilocybin is being studied for use in treatment-resistant depression. METHODS: In this phase 2 double-blind trial, we randomly assigned adults with treatment-resistant depression to receive a single dose of a proprietary, synthetic formulation of psilocybin at a dose of 25 mg, 10 mg, or 1 mg (control), along with psychological support. The primary end point was the change from baseline to week 3 in the total score on the Montgomery-Åsberg Depression Rating Scale (MADRS; range, 0 to 60, with higher scores indicating more severe depression). Secondary end points included response at week 3 (≥50% decrease from baseline in the MADRS total score), remission at week 3 (MADRS total score ≤10), and sustained response at 12 weeks (meeting response criteria at week 3 and all subsequent visits). RESULTS: A total of 79 participants were in the 25-mg group, 75 in the 10-mg group, and 79 in the 1-mg group. The mean MADRS total score at baseline was 32 or 33 in each group. Least-squares mean changes from baseline to week 3 in the score were -12.0 for 25 mg, -7.9 for 10 mg, and -5.4 for 1 mg; the difference between the 25-mg group and 1-mg group was -6.6 (95% confidence interval [CI], -10.2 to -2.9; P |
| Document Type: | article in journal/newspaper |
| Language: | English |
| ISSN: | 0028-4793; 1533-4406 |
| Relation: | info:eu-repo/semantics/altIdentifier/pissn/0028-4793; info:eu-repo/semantics/altIdentifier/eissn/1533-4406 |
| DOI: | 10.1056/NEJMoa2206443 |
| Availability: | https://vbn.aau.dk/da/publications/ed91b9cf-445b-40db-ba63-843bb038eb26; https://doi.org/10.1056/NEJMoa2206443; https://www.scopus.com/pages/publications/85141170646 |
| Rights: | info:eu-repo/semantics/closedAccess |
| Accession Number: | edsbas.DCF9B70 |
| Database: | BASE |