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Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study

Authors
Robin Carhart‐Harris,Anna Ehrlich
David Erritzoe,Rohan Borschmann,Morten Fenger-Grøn,Michael Benros,Wolfgang Michel,Ting Li,David León-Jiménez,Marta Rosa,Karen Gripp,Ida Behrens,Christopher Young,ali fırat sarp,Courtney Yuen,TZU-CHUN CHEN,Branko Aleksic,emmanuel ndashimye,Chisom Obi-Jeff,Yating Dong,Samantha Colquhoun,Christina Vargas,jenny hill,Mohammad Razi Jalali,Daniel Engelman,Fiona Lobban,Oleg Sysoev,Kurt Chudej,Avi Feller,Jennifer Thompson,Lindsay Kendall,Karin Cadwell,Paolo Picco,Phunlerd Piyaraj,Margaret Thomason,Joseph Kado,Viviana BONO,Bianca Lattanzi,Christian Braudrick,Heather Boyd,Felipe Pereira,Diego Mariano,Sergey Shkodkin,Mark Goncharenko,Charles Henry,Karapet Davtyan,Kirill Nyushko,Robert Heyderman,Valery Shevchenko,Mukhtar Yakhyaev,Yulia Smirnova,Дмитрий Слинкин,Sharada Nandan Raw,Maryna Melnyk,Alexandr Pankin,Oxana Prudnikova,István Kádas,Ilya Leyderman,Evgenii Archakov,S.A. Bedina,Jaël Muls,Jodi Feser,Mengyi Li,ELENA ZAVYALOVA,Gaofeng Luo,Yu Zhong,Roman Drnovsek,Yang Dai,lizhi zhu,Xin Ming,Hiroaki Sato,Raina Jose Cherappanath ,Masaomi Kubota,José Isaac Ramírez-Macías,Lucy Li,Silvio Alejandro Alcivar Molina,Skaidre Jankovskaja,Yueming Hu,Andreia Pinto,Oksana Hrytsiuta,Асель Джумагалиева,Ariela Goldenshluger,Zaur Mirzaev,Thuy Ingrid Nguyen-Thi,Francely Santos,Liujie Wang,Ali Mohamed Alshabi,Doris Sippel Dörr,D Samuel Joshua Viswas,Geoff Lipsett-Moore,Carlos Cal y Mayor-Luna,Claus Boye Asmussen,Zhongrui Li,Shaymaa Fadhel Abbas Albaayit,Yitong Xu,Ricardo Silva,Putu Satya Pratiwi,Ievgenii Ponomarenko,Leslie Blanchet,Ohya Yuichiro,GÜRAY SALIHOGLU,Diane Ward,Domingo Bodet,Partha Sarathi Banerjee,Sergey Zhdanov,P Sasikala,Olli Eskola,zemin wang,Tao Yin,Jhon Diego Martínez-Alvarado,Tanvi Lather,Gordon Rogers,Seyedehnafiseh Mirniaharikandehei,Javier de Jesús Domínguez Fonseca,Sang Hyun Jo,Rizwan ,Mohd. Haz Hairul Amran,KÜBRA HAMZAOĞLU,Celsiane Aline Vieira Araújo,Kaori Fujiwara,Tingzhuang Han,Thomas HUSSON,Ahmad Saleh,三好 由華,Naila Shaheen,Liudmyla Shapovalova,Melisa Martinez-Alvarez,soheyla yadamani,María José Serna Iglesias,Елена Мачнева,Natalia Chichkova,Maya Kashuba,Sergey Sterlikov,Michael Zharikov,Marat Ezhov,Silvia Magni Manzoni,Angela Pistorio,Yung Hou Wong,Jaewon Lee,Rosaleen Chun,Katarzyna Sanak-Kosmowska,Mariana Khezheva,Sara Nicolai,Rahsan Sivis Cetinkaya,Arpi Topchyan,Matthew Moy de Vitry,N/A ,ozgur duman,Meng Jiang,Ken Takai,NAGA SRINIVASU LINGAMALLU,Николай Котов,Tatyana Gorchakova,Semakova Victoria Borisovna ,Philipp Stirner,Aida Hansen,Toufik BELAID,paolo santangelo,Ain De Horta,JOAQUIN LLACER,Maha Al-Mozaini,Simon Bray,Владимир Григорьев,Rachel Cable,rui huang,Nikita Pavlov,Carlos Mario Castrillón Castro,Gabriela Vlase,Özgün Yavuz,RABIA Musheer Aziz,Sabrina Florencia Mansilla,Jay Zampini,Nishikanta Tripathy,Miriam Rinneburger,Pieter de Vries,Zhao Yan,Victoria Lanclos,Yuki Yokoi,Olena Stashchuk,Teresa Helena Schoen,Zhao-Lin Cai,Vikash Chandra Tripathi,Yewei Xu,Аркадий Ашиев,Gladness Mwanga,Akwatu Khenti,Irfan Engin,upanya ,Carmel Patterson,Jennifer Huling,José Augusto Afonso,Eun Young Park,Jane Armer,Mingxu Hu,Jennifer Bickhaus,Oksana Zolotarova,Sien Benoit,Tulani Matenga,Олег Пилипчук,Luca Iseppi,JIPENG YAN,David Ernst,Bruno Meurers,Daisuke Watanabe,Robert Loto,Maritza Canales,IRFAN LONE,Jaroslaw Fugiel,Vincent Ustach,Dagnachew Muluye Fetene,Iryna Tsareva,Suman Mitra,Zoi Nikiforidou,Govardhan Dandu,Till Völger,Aditya Sinha,Ignacio Ibarra,Katelyn King,Stephan Kindermann,Achim Zielesny,Xin Wang,Zhihui Deng,Benjamin Verillaud,ignacio Villanueva Bendek,Alessandra Quarta,Giorgio Tofani,Robert Calkins,Olga Shcherbakova,Drisya J,Victor Augusti Negri,Jianhua Zhang,David Nichols,Oscar Marin,Ali Elbireer,Bienvenido Jiménez,Andrea Margheri,Jacob Alexander Lykke,Joël Bertrand FOKOM DOMGUE,antonella insalaco,Gaëtan-Romain Joliat,José Enrique Crespo Amorós,Takashi OKADA,Tomoko Shiino,Francisco Parres,Marco Floridia,Marc-Oliver Grimm,Marinho Lopes,giovanni filocamo,Oliver Grottke,Christopher Pell,Lorcan Ruane,Andrea Necchi,Marina Giuliano,Richard Voegels,Nicholas Gould,Mathias Buttmann,Marco Bernardo,Michele Loreti,JINJIAN LU,Miguel Camafort-Babkowski,Etsuro Hatano,Arlene Siefker-Radtke,fabrizio De Benedetti,ishak tekin,Susan Donath,Marc Rodger,Simon Noble,FRANCISCO YUS,Andreas Griewank,Karen-Margrethe Simonsen,Maciej Goniewicz,Jesse Young,Krishnamurthy Sriramesh,Jonathan Carapetis,Nadezhda Pripuzova,Stefano Salgarello,Alice Moult,Yasin Ergunt,Lindsay Matthews,Алена Беляевская,Charles Gilks,Kongbo Li,Mariwan Al-bajalan,Adam Tucker,İLKER SEL,Gianmarco Tesone,Yoshiki Motomura,MANUEL MATEU-SALAT,Artur Hellich,Kento Rammitsu,Yong-Seok Seo,Inthira Yamabhai,OSCAR PERALES,Елена Данилова,Lidia Antonova,Татьяна ,Shriram Ananganallur Nagarajan,Kristi Glotzbach,Christian Cossio-Mercado,Carah Figueroa,Daniel Kazenwadel,Michael R. Jost,Лидия Семенова,Takahiro Shimoda,Shi-Sheng Li,Valerii Bohdan,REZEG Khaled,Piotr Lewandowski,Frank-Mattias Schäfer,Taiki Nishihara,Sydney Hans,Satoko Ono,Florian Effenberg,David Griwatz,Iain Hutchison,sergey gladkov,Dorothy Bishop,Marie-Eve Robinson,Lloyd Trefethen,meryem etoz,María Gómez Bravo,Ferah Armutcu,VICTOR HUGO VAZQUEZ,Lennart Salmén,Yu Ye,Shan Chen,Zhi Liu,Sarah Sharabiany,Kiran Budhrani,Nico Attempati,Dorothea vom Bruch,Tyler Millhouse,Danielle Hayes,Drake Philip,Nayoung Kim,Rana Faisal Tufail,Eleonora Brivio,David Oriko,Leslie Banks-Sills,Hongdi Wang,Motoyuki Ishikado,Anthony Clemons,Anastasia Averkova,Liudmila Alieva,Nadia Hamdy,Shankar Badiger,Mark Portelli,Finja Wrzodek,Kostiantyn Ivangorodsky,建波 ,Michael Levine,Yangjie RUAN,Junchao Chen,Semra BORAN,emre gönüllü,Yoshimasa Kurihara,Ritesh Shukla,Xiangshang Li,Dmitry Izergin,Jennifer Im,Zvonimir Boban,Pawan Kumar Chamling,Antonio Costa Filho,Christian Avalos,Yassine Charabi,Shijie Dong,Maryam Khalili,Andrea Libano,Vito Crismale,Kyle Rowden,вячеслав терентьев,S Bruce Greenberg,Kate Adams,Héctor Olivero,garen markarian,Alexey Kudrinskiy,Bianca Maria Osculati,Iryna Zakharava,Rouhollah Shakernejad,Anderson Duarte,Adem Halil Kulahlioglu,Yapparova Venera,Marianna (Марианна) Karpova (Карпова),Catherine Olufunke Falade,Hanna Vihonen,Diana Carolina Gutiérrez Ramírez ,Hjortur Hjartarson,Benedikt Boesen,yingying jiang,abdul qadir,Darío Ramirez,hua yang,Nicholas Athanasiou,Colleen Hunt,Luyao Wang,Qihua Xiao,Savesh P.S Rajput,jianlin wan,Julian Kellner-Rogers,Boru Gao,Gulraze Wakil,Suchit Dadia,Wenji Zheng,Hirotoshi Kawashima,Yonglong Qu,Kyeongdae Kim,Zhi-qing HU,Марина Соколова,Бобуржон Абдухалилов,Marco Antonio Perruso,Alisen Ayitewala,Gorbatov Dmitry,Burkhard Morgenstern,Konstantin Obraztsov,Roland Draxler,Sinan Ertemel,Misagh Naderi,Allison Yau,Rayann Atway,Melissa Gresalfi,Carine Muniz Rodrigues,Karen Hills,Sakae Toyoda,Viacheslav Kharzhevskyi,Allison Werner-Lin,Anna Milberg,Cate Macinnis-Ng,Hannah Tedds,amine slaoui,Stefan Nickel,Zeki Gökçil,Laurent Potvin-Trottier,SOO RHEE,Daniela Hlávková,Naomi Caselli,Sylvain Cros,Yang Li,Christian Schuy,Ze Wang,Harald Vöhringer,Keith Falkner,Ying Zhang,Людмила Егорова,joyce schroeder,Lisa Diamond,Raluca Fleischer,Francesco Baldo,Vicky C. Tam,Hossam M. Abdel-Aziz,Alexander Coulton,Bo Ye Sun,Alexey Galkin,Vitaliy ,Suikina Nobre Santos,Zhao Yang,Susheel Chhabra,Roman Braun,Qingyi MU,Svetlana Vinogradova,María Carmen Peña Ardid,Elizabeth Hitches,Susanne Schmitz,Tomasz Jakubowski,Yuebing Lin,Mathis Böttcher,Markos Kyritsis,bo hou,Terry Spitz,Eniko Berei,Shiwei Li,Ludmila Juricek,Tosin Ekundayo,Filipe Baumgratz,Oscar J Garay,Justin Johnson,Tiziana Laureti,Fabio Bendana,Zunda Chisha,Stella Jes Varghese,Marie Dumont,Aleksandra Gawlik,Tamam Nafikova,DO-YOUNG KIM,Rafael Silva Guedes,Angeliki Galanopoulou,Pol Welter,Martina Bevacqua,Alevtina Safronova,Seth Bechis,Ana Clara Sarzedas Ribeiro,Nigar Babakhanova,George Henderson,Ming-Chih Huang,Ryuji Uchida,WAGNER BETTIOL,betul sozeri,Daniel Vieira,Alina Shumatbaeva,Olena Kniazieva,Moshe Milshtein,Marcelo Kuroda,Stefan Riedmaier,Cleverson de Souza,chanmiki sayoo,Theodore Stanoev,Delan Younus,Xi Tian,Jesse Buijs,Danelle Devenport,Brynne Raines,Matus Hyzny,Shakib Daryanoosh,Heng Jin,Roman Ukrainets,Валентина Горленко,Jason Moran,Sónia Martins,Charles Wortmann,Elżbieta Kryj-Radziszewska,Matthias Marco Wiecha,Yiming Xiao,Andrea Király,wang yang,Edward Esplin,jiang wu,Assaf Marom,David Dunne,Lili Kokoti,Florian Girtner,Alessandro D'Ausilio,Rie Endo,Sung Ho Jeon,Stephen Wang,Helena Van den Steene,Flore Croux,Agete Tadewos,Terayama Takero,Vladimír Svoboda,Jaloliddin Abdurakhmanov,Grace Meaker,James Shapiro,Yuka Matsuki,Narine Sarvazyan,Chandanpreet Kaur,Sarah Rohlfing,Инна Бессарабова,Stefano Pigola,Xiaoen Huang,Brett Fajen,Vikas Maddukuri,Alexei Kireyev,Jugal Mohapatra,Elena Varlamova,Guy Lamb,Salah A. Mohamed,Matthew Wang,Connor Murphy,Robert Rowlingson,Tuula Aalto,Motsoboeana Lesaoana,Andrea Vieth-Hillebrand,Laura Ferreira,Jaroslaw Mirek,Bing Shen,John Katsos,Ольга Рожнова,Bernardo Costa Neves,Marco Badinella Martini,Laura Doepker,Tanmoy Halder,Laura Fabbri,kelly barros,ışıl sarıkaya,Vivian Huang,Whitney Bader,Ruwayda Petrus,abderrahim hantoute,Onuma Piasai,Marlene Kretschmer,Guillermo Llamazares,Hehai WU,Elsayed M. 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Aremu,Sampurna Sengupta,Sharon Attipoe-Dorcoo,Susanna Calling,Fernanda Passarini Lopes,Jared Bok,Mihaly Koltai,John Meadows,Yan Liu,Guowei Huang,Yueke Hu,Tunca Karasu,Mingjing Zhao,Philip Greenland,Cameron Griffiths,Ariane Priscilla Magalhães Tenorio,LUIGI MARENGO,Eurides Santos Pinho,Peggy Glenn,Roberto Piro,Michel Gerboles,CASTEGIN TURGUNBAYER,Amirouche FERNANE,Sarah Lumley,Roeland Voorrips,Hiroshi Hibino,Nghi Phan Huu,Lucio De Capitani,MA. LAURA ORTIZ-HERNÁNDEZ,Василий Сериков,Silvia Pomella,Antonio Jesús Martín Mateos,Naomi Inoue,Bo Lu,Zimi Jenmy Zhang,Tessa Kok,Nataliia Vinnikova,Yun Jeong Lim,Djamel Belatrache,Wladimir Patricio Chávez Ormaza,Annalisa Belloni,Sören Wallbach,Qifan Zhang,Laura Meems,Raymond Spearrin,Dionatas Andreghetto,Stefanie Vogel,Denisse Gutierrez,Felice Quartinello,Delphine Grynberg,Philemon Kasyoka,Zoe Wyatt,Rajarshi Das Bhowmik,Mario Merola,Wentao Cao,Juul Tegels,Pierre-Louis LOYHER,Frederico Ferreira,Christine Wulandari,Malamo Countouris,Pål André Hegland,Siti Aminah Muhammad Imran,Yongmin Yoon,Chloe Clifford Astbury,Bernhard Grau,Alexander Pollard,P. Olof Olsson,Carlos Aliaga Valdez,Hendrik Jansen,Yeşerin Yıldırım,zeba seraj,Micol Pennacchio,Joakim Larsson,Niilo Kalakoski,Oleg Farat,Ivan Yecid Forero-Sandoval,Sabrina Viktoria Kirchleitner,DR.hashim Aldedah,Sophie Sagawe,Aizhan Bizhanova,Monira El Genedy,Evgeny Kapustin,Nan-sheng Cheng,Baoguo Zhang,Stanisław Maksymowicz,Francois Gorostidi,Marta Goralska,Shiva Raj Mishra,María V. 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Hernandez Villegas,Claudio Cusini,Katharine Jacobs,Masoud Taleb,Courtney Collins,Ahdiar Fikri Maulana,Xiangming Meng,Stephen Hasak,Ji Eun Park,Armando J Espadas,Dominik Rudolph,Michael Werner,José Benedito dos Santos Batista Neto,Ricardo Vêncio,Marisa Stebegg,Jing Tao,Luzia Keupp,Hien Bui,Kraingkrai Ponhong,Toshimitsu TSUGU,Xuezhe Xu,Shihara Perera,Kornelia Osieczko,Maria Marcela Cameranesi,Jens Güdde,Emily Cai,Christelle Bonnet,Matthew Anderson,Masaharu Tokoro,Yuan Fang,shambhu ghimire,KARINE DEMARTINI,Christina Dieli-Conwright,Soumeth ABASSE,Salvador Doblas Arrebola,GANG REN,Michael Wilke,Tyler Acorn,Rakesh Mazumder,David Bourell,zied Tayeb,Oleg Rustemov,Meredith Akerman,Jenni Blomgren,Charles Rotimi,Éva Kalmár,Roberto Avendaño,Sofia Björklöf,Richard Wilson,Nikita Petrov,Anna Drab-Kurowska,Farman Ullah,Novri nelly,Gizem Önal,Joachim Geiger,Emily Gleeson,sucheta singh,Petros Georgopoulos,Søren Pjengaard,Gianpaolo BASILE,Xiaojun Zhao,Nikhil ,Hemamalini Mariyappa Jagadeesh,nahla BOUZIDI,Alex Pearson,Erika Moreno,huang chao,Grace Kim,Laura Pineda Cirera,Christophe Huynh,carine halaby,Suman Sinha,Sahil Tandon,Ningqiang zhang,Essam Sourour,Irena Maus,Anshu Kumari,Helen Tais Da Rosa-Silva,MINH TRAN,Andres Schmidt,Erika Solange Imbett Vargas,Jaqueline Vaz de Oliveira,Xi Feng,Atsunori Yorozu,Carolina Quintero-Gil,Se Hun Kang,Hélène Rossinot,Rossella D'Aloisio,Jiangshui Zhang,Marina Lebedeva,Shigeaki Ogibayashi,jung han yoo,Diana Carlone,Jean-David ALBERT,Dr. Ranjeet Singh,Shirlee MacCrimmon,Ashraf Hamdan,Kenji Taguchi,Mykhailo Faifura,Александр Королев,Heidi Raubenheimer,Kirsti Jylhä,Hans Juergen Netter,David Pike,Stefanie Doht,Levan Midodashvili,Roya Kokabi,Stephanie Correa,ASHIMA BHASKAR,Jasleen Kaur,Rajeshri Karki,Rolf Rüfenacht,Denine Crittendon,Tahvi Frank,Pui-Yi Lily Liew,Zhaolong Yu,Boudewijn Plaat,Katelyn Heimbruch,Biju VC,Kevin Bain,Alessandro Sinelli,Praveen Shetty,Silviu Daniel Preda,Vadym Tarasov,Misaki Takeda,Satoshi Tanida,Mauricio Diazgranados,Alia Madain,Zhiguang Xing,Seth Bigelow,Anton Poje,Mariline Candeias,Vladimir Chab,Mustafa Turker Duman,Joshua Stone,amaranta kahn,Kenneth Perez Quintero,Ismail Ismail,Mahrima Parvin,Ilya Kravchenko,Zoe Falomir,Dmitry Gabrilovich,Jin-Hui Wang,Damien Desbruyères,Sami Pajunen,Adrian Dominguez Castro,Kavita Kasat,Timothy Ingleton,daniel calbino,Dimitrije Nikolić,Zoe West,Rabia Nazir,ARIANE ALBERS,Yanjun Liu,Duygu Gülmez Sevim,Maria del Carmen Córdoba Sellés,Alejandro Herreros Pomares,Sang Min Lee,Evgenii Savel'ev,Maroš Sirotiak,Agni Kumar Biswal,Amitojdeep Singh Brar,Leonor María Martínez Serrano,Virimchi Pillutla,Juliana Cardoso,YASEMİN COŞKUN,Danya Goodman,MARIA CASTRO MANZANARES,Ahmad Siavashi,Quancheng Cheng,HungFu Tseng,Abhijit Chakraborty,Alice Lin,Matteo Monti,Nessa Golden,Felix Bauer,Ivan Nascimento,Jingchen Ding,shandong Ye,Xiaoxue Chen,Julia Montes-Landa,David Delil Kara,Jessica Faubel,LITONG FENG,Paula Larrañaga,Achille BASILE,Christiaan Boonen,Georden Jones,Serhad Bilim,Vinyas Harish,Pavel Osmancik,Daniel Bellingradt,Nosaiba Ryalat,Alan Du,Taoufik A . Haji,bahar kharazian,Amal Mubark,Hyeok Choi,Jose Carlos Garcia-Garcia,Shirin Modarai,Misheck Julian Nkhata,Rui Chen,Yophtahe Woldegerima,Dorothy Johnson,igor duque gonçalves da silva ,Ross Greenwood,Jithin Thulasi Chand,Jiho Shin,Andee Kaplan,Nataliia Moroz,Mark Bolstridge,Camilla Day,David Erritzøe,Mendel Kaelen,Michael Bloomfield,James Rickard,Ben Forbes,Amanda Feilding,David Taylor,Steve Pilling,Valerie Curran,kjersti vetvik
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,David Nutt
Published
May 17, 2016
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Abstract

Summary

Background

Psilocybin is a serotonin receptor agonist that occurs naturally in some mushroom species. Recent studies have assessed the therapeutic potential of psilocybin for various conditions, including end-of-life anxiety, obsessive-compulsive disorder, and smoking and alcohol dependence, with promising preliminary results. Here, we aimed to investigate the feasibility, safety, and efficacy of psilocybin in patients with unipolar treatment-resistant depression.

Methods

In this open-label feasibility trial, 12 patients (six men, six women) with moderate-to-severe, unipolar, treatment-resistant major depression received two oral doses of psilocybin (10 mg and 25 mg, 7 days apart) in a supportive setting. There was no control group. Psychological support was provided before, during, and after each session. The primary outcome measure for feasibility was patient-reported intensity of psilocybin's effects. Patients were monitored for adverse reactions during the dosing sessions and subsequent clinic and remote follow-up. Depressive symptoms were assessed with standard assessments from 1 week to 3 months after treatment, with the 16-item Quick Inventory of Depressive Symptoms (QIDS) serving as the primary efficacy outcome. This trial is registered with ISRCTN, number ISRCTN14426797.

Findings

Psilocybin's acute psychedelic effects typically became detectable 30–60 min after dosing, peaked 2–3 h after dosing, and subsided to negligible levels at least 6 h after dosing. Mean self-rated intensity (on a 0–1 scale) was 0·51 (SD 0·36) for the low-dose session and 0·75 (SD 0·27) for the high-dose session. Psilocybin was well tolerated by all of the patients, and no serious or unexpected adverse events occurred. The adverse reactions we noted were transient anxiety during drug onset (all patients), transient confusion or thought disorder (nine patients), mild and transient nausea (four patients), and transient headache (four patients). Relative to baseline, depressive symptoms were markedly reduced 1 week (mean QIDS difference −11·8, 95% CI −9·15 to −14·35, p=0·002, Hedges' g=3·1) and 3 months (−9·2, 95% CI −5·69 to −12·71, p=0·003, Hedges' g=2) after high-dose treatment. Marked and sustained improvements in anxiety and anhedonia were also noted.

Interpretation

This study provides preliminary support for the safety and efficacy of psilocybin for treatment-resistant depression and motivates further trials, with more rigorous designs, to better examine the therapeutic potential of this approach.

Funding

Medical Research Council.

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