First Europe-wide platform study on the efficacy and safety of therapies
Berlin, 09.01.2025
Depression can affect anyone. The illness is common and often severe. Depression is now easily treatable, usually with a combination of psychotherapy and medication. Nevertheless, it can take some time to find the right therapy. Not every medication works equally well for every person. Researchers at six European university hospitals under the leadership of Charité – Universitätsmedizin Berlin have joined forces to gain reliable findings on new and known therapies more quickly. The key is to be a joint study design, supported over the next four years by the Wellcome Trust with the equivalent of more than 13 million euros.
According to the World Health Organisation (WHO), major depression is one of the main causes of the global burden of disease. Although there are numerous medications to treat depression – around 30 antidepressants are approved in Germany alone – some of these patients cannot be helped permanently despite multiple treatment attempts. Why is this and how can we find out more quickly what really helps each patient? Researchers at six European University Hospital Alliance (EUHA) hospitals are working together systematically to find answers in the PEARLDIVER project.
Pearls of depression research
Clinical studies are the basis of evidence-based medicine. However, many of the studies conducted are not conclusive enough to draw reliable conclusions about clinical practice. Available treatments are often only effective for some patients and the approval of new therapeutics for mental illnesses lags behind that of other medical fields such as oncology, infectiology or neurology.
‘There is a great need for new, safe and demonstrably effective therapies for depressed patients for whom the first treatment does not work,’ states Prof Christian Otte, Director of the Department of Psychiatry and Psychotherapy at Charité’s Benjamin Franklin Campus. The medical director of the major European project has high hopes for the new and structured approach: ‘Our platform study will significantly accelerate the development and testing of such treatments. At the same time, we will be able to clarify more quickly which of the therapies already available is best suited to the individual patient.’
One structure – many studies
In order to identify the pearls of depression research and make new drugs available quickly, the researchers rely on the highly efficient methodology of a platform study. While new or existing treatment approaches were previously evaluated in individual studies in which participants were randomly assigned to the intervention or a control group, a common infrastructure and a common control group are used to test many treatment approaches while maintaining the randomisation principle of group allocation.
‘Clinical trials are very resource-intensive and costly. Until now, the entire infrastructure and logistics for each study have had to be set up from scratch. You could compare this metaphorically to building a new stadium for every football match. With PEARLDIVER, we are taking a different approach: we are figuratively building a large football stadium together and all partners can then use this infrastructure for an almost unlimited number of matches – or studies,’ explains Stefan Gold, Professor of Clinical Neurosciences at Charité and Scientific Director of the project. ‘In addition to the speed, the significance and comparability of the individual studies will also increase.’
The aim is to establish a Europe-wide research infrastructure over the next four years, with the help of which solid findings can be obtained in accordance with the highest scientific standards in comparisons of study and control groups for new and known treatment approaches. The first year will be used in particular to set up the platform. The platform will then prove its suitability and efficiency by testing the efficacy and safety of two new drugs used for depression. The first patients are to be enrolled in trials in 2026.
Patients help to shape
Platform studies are already being used successfully in other medical fields, for example in oncological research. This approach is new in the field of mental health. What is also new is that those affected have helped to shape the study design as co-operation partners. The patient representative in the project, Fanni-Laura Mäntylä, says: ‘We want to work together to find better solutions for how clinical trials in the field of mental health are designed and conducted, how the treatment of mental illness can be further developed and how people with mental health problems can be better helped.’
As several treatments can be tested at the same time, a reusable infrastructure is extremely efficient. The burden on trial participants is reduced. Regulatory and ethical approval processes are shortened. Interim analyses allow quick conclusions to be drawn as to whether a treatment is likely to be successful. Obviously ineffective study arms can be quickly discontinued.
‘The innovative approach of a platform study is particularly interesting because it makes the testing of new therapies for depression more resource-efficient and standardised. The project will help researchers work together to find answers more quickly as to whether treatments are effective and for whom they are best suited,’ emphasises Dr Kim Donoghue, Senior Research Manager at Wellcome. Perhaps Europe’s largest depression study can also serve as a model for other mental health conditions.
About Wellcome
The Wellcome Trust is a charitable organisation based in London. The Trust supports research and science with the aim of finding solutions to the current health and social challenges we all face. In particular, Wellcome supports research in the life sciences with a focus on mental health, infectious diseases, climate and health.
Leave a Reply