Early Psychosis Multi-arm Multi-stage Platform Trial (PUMA)

With lived-experience involvement being central to their design and implementation, multi-arm multi-stage (MAMS) trials have revolutionised clinical trials methodology, updated standard-of-care and resulted in improved patient outcomes in many illnesses. As mechanistically-based experiments they also illuminate underlying biology. We propose similar transformation for the treatment of early psychosis. Over 30 months we shall design the trial platform, producing a trial protocol and the necessary infrastructure ready to be implemented. We shall involve patients, carers and clinicians across the country to design all aspects of this trial platform, ensuring that it is meaningful for patients and deliverable within UK services. We will use an established, objective method of selecting drugs to include. We will select a hub and chief investigator for the platform and establish a national network of research sites. In the following 3 years we will complete the first 2 treatment arms of the trial platform. We will secure funding and select the next treatments to be tested. We will broaden out the treatment selection group to enable the inclusion of non- pharmacological treatments. Our aim is to establish an infrastructure to enable the rapid trialling of new treatments in early psychosis, accelerating improved outcomes for patients.