Advancing innovative interventions for mental, behavioural and neurodevelopmental disorders

The main goal of this opportunity is to support activities that help tackle diseases and reduce disease burden, with a special focus on mental, behavioral, and neurodevelopmental disorders. It aims to foster the development of innovative therapies, improve collaboration by sharing data and knowledge, and connect relevant databases using FAIR principles. The program encourages the use of advanced research infrastructures, involvement of stakeholders such as patients and clinicians, and the creation of personalized, inclusive, and ethically sound interventions using technologies like AI and wearable devices. The geographic scope covers the EU, Associated Countries, and also includes the USA and other non-EU countries with specific arrangements for Horizon Europe projects.

• Must focus on mental, behavioural or neurodevelopmental disorders listed in Chapter 6 of the ICD (excluding rare diseases)

• Must propose innovative therapeutic interventions and/or complementary non-invasive approaches (e.g. neurostimulation, digital tools, psychosocial therapies)

• Must include rigorous clinical studies demonstrating safety, efficacy, and insights into mechanisms of action, with appropriately sized and diverse patient cohorts

• Must engage patients, caregivers, clinicians and other stakeholders to ensure interventions are end-user optimised and inclusive

• Must use or generate FAIR data, ideally leveraging existing EU-funded cohorts, registries or research infrastructures (e.g. BBMRI, ECRIN, EBRAINS)

• Must involve SSH experts and perspectives to assess societal impact, ethical implications, and ensure inclusiveness and acceptance

• Should demonstrate a pathway for regulatory engagement and future clinical or public health uptake

• Must include a business case and potential exploitation strategy, especially relevant for SMEs

• If clinical studies are included, the dedicated annex template in the submission system must be used

Examples:

• A project testing a new AI-driven wearable device to monitor symptoms in children with neurodevelopmental disorders, involving both clinicians and families.
• A clinical study that uses a shared European database to develop personalized treatments for depression, ensuring patient data follows FAIR principles.
• A project that brings together researchers, patients, and caregivers to co-design an intervention for behavioral disorders, using state-of-the-art research facilities.

• Personnel costs for research and clinical staff
• Costs for clinical studies and trials
• Purchase or rental of equipment and wearable devices
• Data management and integration costs (including FAIR compliance)
• Stakeholder engagement activities (e.g., workshops, patient involvement)
• Travel and subsistence for project meetings and fieldwork
• Costs for using advanced research infrastructures
• Development and implementation of digital tools (e.g., AI software)
• Dissemination and communication activities
• Administrative and overhead costs

Restrictions: Eligible expenses must comply with the lump sum rules of the Horizon Europe Programme. Detailed rules are available in the official decision documents.

• Budget for this Call: 50,000,000€
• Number of Grants attributed: 7
• Maximum value per project: 8,000,000€
• Minimum value per project: 6,000,000€

• Applicants must be legal entities established in eligible countries, including the EU, Associated Countries, and the USA.
• Entities from non-EU/non-Associated Countries may be eligible if specific arrangements exist.
• Projects involving satellite-based data must use Copernicus and/or Galileo/EGNOS systems where required.
• Entities classified as high-risk suppliers of mobile network equipment are not eligible for certain topics.
• Projects must adhere to the blind evaluation rules in the first-stage application.
• Clinical studies must use the dedicated annex template provided in the submission system.