https://www.monash.edu/research/research-news/world-first-psilocybin-clinical-trial-in-the-treatment-of-generalised-anxiety-disorder-receives-ethics-approval * Home * Courses * Library * Donate Previous menu Toggle navigation * About About + About + Who we are Who we are o Who we are o A proud history A proud history # A proud history # Sir John Monash Sir John Monash # Our living history timeline Our living history timeline o Rankings and reputation Rankings and reputation o A culture of integrity and respect A culture of integrity and respect # A culture of integrity and respect # Diversity and inclusion Diversity and inclusion @ Diversity and inclusion @ Diversity and inclusion at Monash @ Future students @ Staff # Indigenous Australians Indigenous Australians # Respect Now Always Respect Now Always @ Respect Now Always @ NSSS @ 2016 survey results @ AHRC Recommendations Response @ Monash bSafe app @ Safety & Security - Contact Us o Freedom of Speech and Academic Freedom Freedom of Speech and Academic Freedom + Governance Governance o Governance o University Council University Council o Academic Board Academic Board o Regulatory framework Regulatory framework o Annual Report Annual Report + Structure Structure o Structure o Faculties Faculties o Committees Committees # Committees # Vice-Chancellor's Executive Committee Vice-Chancellor's Executive Committee @ Vice-Chancellor's Executive Committee @ Diversity and Inclusion Committee # Senior Management Forum (SMF) Senior Management Forum (SMF) # Vice-Chancellor's Executive Implementation and Oversight Committee Vice-Chancellor's Executive Implementation and Oversight Committee o Academic structure Academic structure o Senior Monash staff Senior Monash staff # Senior Monash staff # The Office of the President and Vice-Chancellor The Office of the President and Vice-Chancellor @ The Office of the President and Vice-Chancellor @ Vice-Chancellor's profile # Office of the Provost and Senior Vice-President Office of the Provost and Senior Vice-President # Office of the Chief Operating Officer and Senior Vice-President Office of the Chief Operating Officer and Senior Vice-President @ Office of the Chief Operating Officer and Senior Vice-President @ Peter Marshall AM - Chief Operating Officer and Senior Vice-President # Chief Financial Officer and Senior Vice-President Chief Financial Officer and Senior Vice-President # Senior management chart Senior management chart + Strategic direction Strategic direction o Strategic direction o Strategic plan Strategic plan # Strategic plan # Masterplan Masterplan @ Masterplan @ Campus Masterplans @ Frequently Asked Questions @ Login - Monash only @ Featured projects @ News @ Awards @ Contact us # Monash Planning Framework Monash Planning Framework o Sustainable development Sustainable development o Learning and Teaching Learning and Teaching + Our locations Our locations o Our locations o Our Australian locations Our Australian locations o Clayton Clayton # Clayton # About Clayton campus About Clayton campus # Gardens at Clayton Gardens at Clayton @ Gardens at Clayton @ Garden locations map o Caulfield Caulfield # Caulfield # About Caulfield campus About Caulfield campus # Caulfield A - Z Caulfield A - Z o Peninsula Peninsula # Peninsula # Services Services @ Services @ Inclusive practices @ Food outlets @ Chaplaincy # Courses Courses # Peninsula A - Z Peninsula A - Z # About Peninsula campus About Peninsula campus # Department contacts Department contacts # Facilities Facilities @ Facilities @ Campus business lounge @ Chill out room @ Postgraduate study centre @ Parenting room @ MPARC # Student life Student life # Profiles Profiles @ Profiles @ Sophie Paine @ Aleksia Jensen @ Competition T&Cs @ Luke Robinson and Nikos Thomacos @ James Bonnamy @ Pieter Van Dijk @ Sarika Kewalramani @ Maria Gindidis @ Tom Hogan @ From Peninsula to San Francisco @ Lauren Brewer @ Ben Heritage @ Dorcas Yeung @ Max Han @ Ali Mujtaba @ Shihab Sharar Isa @ Sachin Kulatilleke @ Kenji Koyama @ Chelsea Book @ Chloe Pate @ Lorna Martin @ Preeti Kale @ Rachel O'Brien @ Arun Jojo @ Greta Fullagar @ Andrea Tan @ R U OK Day Competition T&Cs # Living on campus Living on campus # News and events News and events # Medicine, Nursing and Health Sciences videos Medicine, Nursing and Health Sciences videos # Education videos Education videos # Industry and community Industry and community @ Industry and community @ Matt Shepherd @ What our graduates say # Our future campus Our future campus # Campus life Campus life o Our international locations Our international locations o Maps Maps o Transport and parking Transport and parking # Transport and parking # Journey to campus Journey to campus # Public transport Public transport # Parking Parking @ Parking @ Staff and students @ Pay As You Use @ Visitor parking @ Special permits @ Parking infringements @ Parking rules, terms and conditions @ Parking safety @ Carpooling @ Accessible parking @ Motorcycle parking @ Electric vehicle charging # Cycling Cycling # Intercampus shuttle bus Intercampus shuttle bus # Carshare Carshare # Transport news Transport news # Delivery access guidelines Delivery access guidelines o Safety and security Safety and security # Safety and security # Report an incident Report an incident # Security offices Security offices # Security services Security services + Contact Contact o Contact o A - Z facilities A - Z facilities o A - Z services A - Z services o A-Z org units A-Z org units * Study Study + Study + Why Monash Why Monash + Courses Courses + How to apply How to apply + Fees and scholarships Fees and scholarships + International International * Research Research + Research + Find a researcher Find a researcher + Institutes and centres Institutes and centres + Research infrastructure Research infrastructure + Our global challenges Our global challenges * Enterprise Enterprise + Enterprise + Partner with Monash Partner with Monash o Partner with Monash o Success stories Success stories # Success stories # Medicines Manufacturing Innovation Centre Medicines Manufacturing Innovation Centre # KASPR Datahaus KASPR Datahaus # Aquahydrex Aquahydrex # PureTech Health - drug delivery PureTech Health - drug delivery # MoodMission MoodMission # Mogrify Mogrify # Janssen collaboration Janssen collaboration # 2D Water 2D Water # 4DMedical 4DMedical # AcruX AcruX # Amaero Amaero # Aravax Aravax # Bionic Eye Bionic Eye # Capsugel Capsugel # World Mosquito Program World Mosquito Program # Erler Zimmer Erler Zimmer # Monash Food Innovation Monash Food Innovation # FODMAP app FODMAP app # Haemokinesis Haemokinesis # Ionic Industries Ionic Industries # ISCRR ISCRR # Janssen Pharmaceuticals Janssen Pharmaceuticals # Monash IVF Monash IVF # Oxytocin inhaler Oxytocin inhaler # PACIA PACIA # Public Transport Victoria Public Transport Victoria # Relenza Relenza # Starpharma Starpharma # SupraG SupraG # Woodside Woodside # Cincera Therapeutics Pty Ltd Cincera Therapeutics Pty Ltd # Pfizer Pfizer # Inosi Inosi # Johnson & Johnson Innovation Johnson & Johnson Innovation # Qpex Biopharma Qpex Biopharma # Additive Assurance Additive Assurance # AskPCOS app AskPCOS app # Opturion Opturion # Janssen - Coeliac collaboration Janssen - Coeliac collaboration # RAGE Biotech RAGE Biotech # RTx | Resonance Therapeutics RTx | Resonance Therapeutics # Pio Tx Pio Tx # mRNA vaccines mRNA vaccines + Commercialisation Commercialisation + Capabilities and facilities Capabilities and facilities o Capabilities and facilities o AgTech AgTech # AgTech # About us About us @ About us @ Principles # Partnering for impact Partnering for impact # Research Research @ Research @ Areas of expertise @ Meet the researchers @ Our students # Contact Us Contact Us o Mining and Resources Mining and Resources # Mining and Resources # About us About us # Areas of expertise Areas of expertise # Partnering for social impact Partnering for social impact # Our students Our students + Monash Technology Precinct Monash Technology Precinct + Access student talent Access student talent o Access student talent o Monash Graduate Research Monash Graduate Research o Monash Industry Team Initiative (MITI) Monash Industry Team Initiative (MITI) + The Generator The Generator * International International + International + Global partnerships Global partnerships o Global partnerships o International sponsor relations International sponsor relations # International sponsor relations # International scholarships and loan schemes International scholarships and loan schemes # External scholarships External scholarships # Contact Us Contact Us # Vingroup scholarships Vingroup scholarships o UNFCCC UNFCCC # UNFCCC # COP 25 COP 25 o International articulation agreements International articulation agreements o Brazil CAPES-PrInt funding program Brazil CAPES-PrInt funding program o Monash University Malaysia Monash University Malaysia o IITB-Monash IITB-Monash o Monash Prato Centre Monash Prato Centre o International partners International partners o Monash SEU China Monash SEU China o Global Engagement Intranet Global Engagement Intranet o International visitors International visitors o Pacific Pacific # Pacific # Research collaboration Research collaboration # Consultancy Consultancy # Our students Our students # Our people Our people # Pacific news Pacific news + Global study program Global study program * News & events News & events + News & events + Latest news Latest news + Upcoming events Upcoming events + Opinion and insights Opinion and insights + Media enquiries Media enquiries + Novel coronavirus Novel coronavirus o Novel coronavirus o Past communications Past communications o COVID Safe Plan COVID Safe Plan o Exposure sites Exposure sites * Skip to content * Skip to navigation * Home * Monash University [Monash Australia] * Courses * Library * Donate * Staff [Staff ] * Students [Students ] * Alumni [Alumni ] * Search Monash University Menu About ( ) * Who we are * Governance * Structure * Strategic direction * Our locations * Contact Study ( ) * Why Monash * Courses * How to apply * Fees and scholarships * International Research ( ) * Find a researcher * Institutes and centres * Research infrastructure * Our global challenges Enterprise ( ) * Partner with Monash * Commercialisation * Capabilities and facilities * Monash Technology Precinct * Access student talent * The Generator International ( ) * Global partnerships * Global study program News & events ( ) * Latest news * Upcoming events * Opinion and insights * Media enquiries * Novel coronavirus More ( ) Toggle Search Monash University CloseClose Search [ ] Search Search Monash https://www.monash.edu/search [ ] See all other results You are here: * Home | * Research | * Research news | * World-first psilocybin clinical trial in the treatment of Generalised Anxiety Disorder receives ethics approval World-first psilocybin clinical trial in the treatment of Generalised Anxiety Disorder receives ethics approval Share this page on Facebook Share this page on Twitter Share this page on Linkedin Share this page on Baidu Email this page Print this page +Share 28 October 2021 Monash University has obtained ethics approval for a world-first clinical trial investigating psilocybin-assisted psychotherapy in the treatment of severe Generalised Anxiety Disorder. In partnership with Incannex Healthcare Ltd, the randomised triple-blinded active-placebo-controlled trial, led by Dr Paul Liknaitzky, will assess the safety and efficacy of psilocybin-assisted psychotherapy alongside exploring how the treatment works. Looking to recruit 72 participants, it is set to be the largest psychedelic research and development project in Australia and will include psilocybin sessions alongside a program of specialised psychotherapy. Generalised Anxiety Disorder (GAD) is a condition that involves intense anxiety and worry most of the time and can be so excessive that everyday life becomes difficult. Experienced by more women than men, nearly six per cent of the Australian population will experience GAD in their lifetime, with current treatments providing inadequate outcomes, problematic side-effects, and high relapse rates. Evidence is accumulating that psychotherapy assisted by psilocybin can provide significant and lasting benefits across a range of mental health and addiction disorders. Psychedelic drugs can induce states of consciousness that are often reported to be remarkable, moving, beneficial, and difficult to describe. Clinical participants also report challenging experiences that, when well supported, are often felt to be highly valuable by the participant. Given the central role of clinical support for both safe and effective outcomes, empathic therapists with specialist training are essential. Therapists working on this trial are qualified mental healthcare workers who are currently undergoing extensive training that will also incorporate a world-first option for trial therapists to receive psilocybin under supportive conditions. Head of Clinical Psychedelic Research at Monash University, Dr Liknaitzky says: "Previous research suggests that psychedelic therapist training can be substantially enhanced if therapists can experience well-supported psychedelic effects, becoming better equipped to accompany clinical participants through profoundly unfamiliar terrain. "That is why we will provide the option to our research therapists to undergo supported psilocybin sessions as part of their training, a process that is likely to improve outcomes for our clinical participants." The impact of this aspect of training will be scientifically investigated from the perspectives of both therapist and clinical participant. Trial therapists will also work under supervision from international psychedelic experts through the duration of the trial. Lead psychedelic trainer and therapist at Monash, Sean O'Carroll, says: "As psychotherapists, we regularly witness the psychological pain and suffering inflicted by severe GAD, a condition which is notoriously difficult to treat. It is increasingly clear that psychedelics - when used in conjunction with intensive and novel psychotherapeutic interventions - have great healing potential. "This trial will provide us with an opportunity to make a real contribution to the field, by deepening our understanding of how to best work with these powerful substances. It's very exciting." Head of Psychiatry at Monash, investigator, and medical lead on this trial, Prof Suresh Sundram, says: "This is a critical hurdle to pass in our efforts to test a novel potentially game-changing treatment for people suffering an illness which is often under-recognised, poorly treated and disabling." This trial, led by the Clinical Psychedelic Research Lab within the Department of Psychiatry and the Turner Institute for Brain and Mental Health, will be conducted at BrainPark, a state-of-the-art research facility at Monash University. "Given the early yet highly promising results from other psilocybin trials for different conditions," says Dr Liknaitzky, "this treatment - alongside innovations we've developed - may deliver a substantial step forward in the treatment of anxiety disorders." Categories Medicine & health Research Tags Dr Paul Liknaitzky Turner Institute for Brain and Mental Health Professor Suresh Sundram BrainPark Mental Health Psychedelic Research * * * * We acknowledge and pay respects to the Elders and Traditional Owners of the land on which our four Australian campuses stand. Information for Indigenous Australians Community * Faculties * Locations * Diversity and inclusion * Safety and security * Sustainable development Resources * Important dates * How to apply * A-Z index * Policy Bank * FAQs Contact * Contact us * Campus maps * Jobs at Monash * Recruit a student * Pay online News * Latest news * Monash Lens * Podcasts * A Different Lens * Monash Life On Our Site * Who we are * Find a course * Find a researcher * Partner with Monash * Sitemap Community * Faculties * Locations * Diversity and inclusion * Safety and security * Sustainable development Resources * Important dates * How to apply * A-Z index * Policy Bank * FAQs Contact * Contact us * Campus maps * Jobs at Monash * Recruit a student * Pay online News * Latest news * Monash Lens * Podcasts * A Different Lens * Monash Life On Our Site * Who we are * Find a course * Find a researcher * Partner with Monash * Sitemap Registered higher education provider ABN 12 377 614 012 CRICOS Provider Number Monash University: 00008C Monash College: 01857J Authorised by Chief Marketing Officer University Marketing, Admissions and Communications Maintained by Monash University Webmaster Team Last updated: Oct 2021 * Accessibility * Disclaimer & copyright * Terms & conditions * Data privacy & cyber security * Data Consent Settings Copyright (c) 2021 Monash University