A systematic review of randomized controlled trials found that MDMA and psilocybin, given with psychological support, may reduce symptoms in highly selected populations under close supervision. The strongest evidence was for MDMA in post-traumatic stress disorder, with a large effect compared to active controls (standardized mean difference = -0.86). Psilocybin showed small benefits for social anxiety in adults with autism and was as effective as escitalopram for long-standing depression on the primary outcome, though most secondary benefits were not significant after correction. Both drugs were well tolerated, but overall certainty of evidence was low or very low.
Australia's Therapeutic Goods Administration rescheduled MDMA in July 2023, allowing its prescription for PTSD outside clinical trials. This manuscript outlines the development of an Australian Clinical Practice Guideline on MDMA-assisted psychotherapy for PTSD, using the GRADE process to weigh benefits and harms against other treatments. A multidisciplinary Guideline Development Group, supported by stakeholder and expert groups, will consider evidence certainty, patient values, resources, equity, acceptability, and feasibility. The guideline will be published on MAGICapp and in peer-reviewed outlets, with a companion guide for people with PTSD and their carers.