Transforming the evidence landscape in depression
EU-PEARLDIVER is a multinational European platform trial for depression to rapidly and robustly assess the efficacy and safety of several therapies simultaneously. With this innovative trial design, new treatments can be added over time as they become available and treatments that turn out to be ineffective will be dropped.
The trial is designed to accommodate different types of drugs and may also include non-pharmacological treatments such as psychotherapy or non-invasive neuromodulation in the future. In a platform trial, several experimental treatments share a control group, which can help to make it faster, more efficient, and more patient-centric.
The Need for New Trial Designs
Clinical trials are at the core of evidence-based medicine. However, in psychiatry, the trials conducted often fail to inform clinical practice because many are too small or have other limitations. Moreover, new drug approvals in mental health have lagged behind other medical specialties and the available treatments only work for a subset of patients. Thus, there is an urgent need for a more efficient, faster and more collaborative way of evaluating the safety and efficacy of new and repurposed drugs as well as comparative effectiveness data for treatments already in use.
Fast Forward with Platform Trials
Traditionally, treatments are evaluated in individual trials, with each trial conducted in a specific setting and requiring its own infrastructure, which is dismantled after completion of the trial. This approach is slow, not very efficient, and limits comparability. In contrast, platform trials use a shared infrastructure for many treatments, shared control groups, and allows new treatments to be added over time. This approach can thus increase the speed at which data on safety and efficacy are obtained, reduce operational costs and participant burden, and increase statistical power and comparability.
A Platform Trial for Depression
The EU-PEARL consortium, funded by the Innovative Medicines Initiative, developed a reusable multinational infrastructure, to run integrated platform trials. Using this infrastructure, we are now launching EU-PEARLDIVER for new and repurposed treatments for depression in six European countries, funded by Wellcome. The trial has been co-designed with lived experience experts, who also play an active role as key collaborators who will vote on all decisions along the way.
Launching EU-PEARLDIVER
We are currently setting up the infrastructure to run this trial in Germany, the Netherlands, Denmark, Spain, Italy and the UK and evaluating the first two pharmacological treatments. With this setup and the regulatory approval in preparation, start of enrolment is anticipated towards Fall 2026.
We will first use this platform trial to evaluate investigational (new as well as repurposed) drugs for treating treatment-resistant depression (TRD), but could also add non-pharmacological treatments in the future.
