Community Research and Development Information Service - CORDIS

H2020

PReDicT Report Summary

Project ID: 696802

Periodic Reporting for period 1 - PReDicT (Predicting Response to Depression Treatment)

Reporting period: 2015-10-01 to 2016-09-30

Summary of the context and overall objectives of the project

Depression is a very common, serious, and in some cases life‐threatening condition, affecting around 350 million people globally with 11% of EU citizens suffering from depression at some point in their lives. Depression is associated with significant socio-economic costs and is predicted to become the greatest cause of disability worldwide by 2030 (World Health Organization, Global Burden of Disease, 2004 update). In 2010 it was estimated that there were approximately 30 million patients with depression in Europe, with aggregated economic costs of approximately €92 billion. Improvements in managing the treatment of depression are urgently needed to contain rising healthcare costs, improve workplace productivity and help to address the overall economic and societal challenges facing the EU.

One major problem to overcome is that it takes several months to identify an effective antidepressant treatment for the majority of patients with depression. It takes 4-6 weeks after starting antidepressant treatment before a physician can detect whether the treatment is working, and more than 50% of patients fail to respond to the first antidepressant treatment prescribed. Approximately two thirds of patients fail to respond to their second treatment and around 80% fail to respond to their third treatment. Therefore, it can take months before a physician identifies an effective antidepressant therapy for their patient. During this time a patient’s ability to work and function socially is severely impaired, individuals may be absent from work for many weeks or months and this places a substantial burden on the economy and healthcare resources

This problem is addressed by the P1vital® PReDicT Test, an online computerised test that can identify, after 1 week of starting treatment, whether or not an antidepressant is working. The PReDicT Test can significantly reduce the time required to identify an effective treatment and thereby decrease the time to response and remission for depressed patients. In this way physicians can reduce the usual 4-6 week treatment cycles to 7-9 day cycles, ensuring that the patient is prescribed effective medication more rapidly and responds more quickly than with current standard of care (SoC) or treatment as usual (TaU) regimens. As the majority of patients with depression do not respond to the first treatment they are prescribed, many patients will experience significant benefit from PReDicT directed treatment. Therefore, the PReDicT Test can have a highly significant impact on the direct and indirect costs of depression. It will reduce the time to response and remission and enable patients to return to work sooner than current TaU, thereby reducing lost productivity and its associated costs. Contact time with physicians, secondary services and consultants will be reduced as the patient will be treated more effectively from the time of initial presentation to remission. Moreover, these positive impacts on healthcare budgets will flow from benefits experienced by patients rather than from cost containment measures or a reduction in services.

Therefore, the objective of the Predicting Response to Depression Treatment (PReDicT) project is to conduct clinical, health economic and commercial research to validate the clinical performance and to complete the pre-commercial development of the P1vital® PReDicT Test, a novel medical device to improve the treatment and management of depression in clinical practice. On completion of the PReDicT project, the P1vital® PReDicT Test will be ready for market launch.

Our specific project objectives are to:
1. Further improve the PReDicT Test for use in clinical practice across Europe, both by healthcare professionals within a clinical setting, and by patients at home.
2. Determine whether, within 8 weeks of starting antidepressant therapy, PReDicT directed treatment results in significantly more patients achieving a 50% reduction in symptoms (response) than treatment as usual (TaU). [Clinical effectiveness].
3. Determine whether the cost to healthcare providers and society is significantly reduced when patient treatment is directed by PReDicT compared to TaU [Cost effectiveness].
4. Determine the critical factors for adoption of the PReDicT Test by clinical practice stakeholders. [Clinical utility].
5. Increase stakeholder awareness and engagement to ensure rapid market adoption, attract further funding and investment and identify potential commercial collaborations to increase global market penetration.
6. Develop a detailed commercialisation plan to maximise global sales of the PReDicT Test following market launch.

Overall, the PReDicT project will enable the P1vital® PReDicT Test to be clinically validated and ready for market launch. This will accelerate commercialisation of the product and enable the company to both raise additional funding and to initiate sales and marketing partnerships for global exploitation of the technology.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In the first reporting period between Oct 2015 and Sep 2016 we have made significant progress on the project including the following main results and deliverables:
- The development of the PReDicT Test, its successful registration as a CE marked Class 1 medical device, and its effective deployment in the clinical study.
- Completion of all UK clinical study set-up activities including securing local ethics and regulatory approvals to obtain First-Patient-First-Visit (FPFV), with a staged approach to EU clinical study set-up activities implemented.
- Initiation of key market research, primarily in the UK so far, to support the future development of a European commercialisation plan.
- The development and launch of multiple communication media including websites, monthly newsletters, social media, and attendance at multiple conferences, trade fairs and pitch events; alongside initiation of stakeholder engagement activities at the patient advocacy, clinician, and parliamentary levels all with a future view to optimise healthcare adoption.
- Via a dedicated Project Management Office, the establishment of overarching organisational structures and management processes were put in place including the development of project plans (Gannt charts), organisation of a project meeting schedule at both the localised and cross-site European levels, and set up and regular usage of financial reporting templates.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The clinical study is currently in progress and until we complete the study and generate the clinical effectiveness, cost effectiveness and clinical utility results in 2018 (period 3) we will not be able to demonstrate the expected impact and value of the P1vital® PReDicT Test which are:
- Improvement in response and remission rates thereby shortening functional disability, impacting both patients and their families in their social and working lives.
- Significant reduction in both healthcare and societal costs
- Significant reduction in ineffective prescribing of antidepressants and associated side effects, by identifying non-response early in treatment
- Significant decrease in antidepressant non-adherence by providing patients with an early indication that the antidepressant they are taking is working which will encourage them to continue taking their medication even if they are suffering from unpleasant side effects.

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