Launch of the PEARLDIVER Platform Trial for drug development and repurposing in Major Depressive Disorder

Published 5 March 2025

EATRIS is pleased to announce a strategic collaboration with an international multidisciplinary consortium led by Charité, Berlin (scientific director: Prof. Dr. Stefan Gold, medical director: Prof. Dr. Christian Otte), who will launch the groundbreaking PEARLDIVER platform trial in six European countries later this year. This innovative trial is set to accelerate the evaluation of new and repurposed treatments for Major Depressive Disorder (MDD) by streamlining clinical trial infrastructure and optimising resource allocation, building on the EU-PEARL study design.

About the PEARLDIVER Platform Trial

PEARLDIVER is a multi-arm platform trial designed to evaluate new therapeutic interventions for MDD in a more efficient and scalable way. A key feature of this trial is the utilisation of a master protocol using a single shared blinded control group, which enhances efficiency and reduces the number of participants required for control arms. It allows new candidate medicines (novel or repurposed medicines) to enter at any time. By sharing clinical trial protocols and infrastructure, PEARLDIVER aims to accelerate the development and validation of novel treatments while minimising costs and participant burden.

Call for Investigators & Additional Trial Arms

The PEARLDIVER platform trial is open for investigators interested in contributing additional study arms. Current funding, provided to the collaborative by the Wellcome Trust covers the set-up of the trial’s infrastructure in six European countries as well as resources to run the first two trial arms and a shared placebo group.

Additional arms of the trial may either secure their own funding or jointly apply with the PEARLDIVER consortium for funding from public or philanthropic sources, and EATRIS and its partners are committed to supporting such potential collaborations.

The trial can accommodate a range of sample sizes for new investigational treatments and detailed trial simulations are available for sample sizes of 40 to 120. Investigators from across the research community, particularly those with repurposed or novel drug candidates that align with the trial’s mission, are encouraged to contact the PEARLDIVER collaborative group to explore collaboration opportunities.

Opportunities for Industry Collaboration

PEARLDIVER represents a Phase 2 Accelerator, designed to de-risk drug development for industry partners. The trial welcomes collaborations with pharmaceutical and biotech companies interested in evaluating promising candidates for MDD within an established and efficient research infrastructure.

Next steps

We invite investigators and developers to express interest to jointly discuss ideas for new study arms and explore ways of including novel or repurposed treatments in the trial. We will then work together with the trial’s Steering Committee with the aim for Clinical Trial Application submission in ~1Q2026.

This collaboration marks a significant step forward in advancing mental health research and improving treatment outcomes for MDD. We invite interested investigators and industry partners to join us in shaping the future of depression treatment through PEARLDIVER.


USEFUL RELATED LINKS:

For more information or to express interest in joining the trial, please contact Martin de Kort, PhD (martindekort@eatris.eu).