Advancing innovative interventions for mental, behavioural and neurodevelopmental disorders

The EU's Horizon Europe program announces a funding opportunity for research centered on innovative interventions for mental, behavioral, and neurodevelopmental disorders. This funding initiative, designated HORIZON-HLTH-2025-03-DISEASE-02-two-stage, is part of the Health Cluster and emphasizes tackling diseases and reducing the disease burden.

Eligible applicants include startups, small and medium-sized enterprises, research institutions, and social sciences and humanities experts. The program encourages collaboration among diverse entities, especially involving patients and their representatives, clinicians, and caregivers, to reinforce research foundations and enhance innovation.

The funding type is a grant, specifically a Horizon Lump Sum Grant under Research and Innovation Actions. Although a consortium is not explicitly required, collaborative projects are strongly favored. Geographic eligibility spans EU member states, associated countries, and potentially some non-EU countries, including the USA.

The targeted sectors encompass mental health issues such as severe depression, anxiety, schizophrenia, PTSD, and autism spectrum disorder. The call aims to support clinical studies for developing, validating, and potentially implementing new interventions, focusing on innovative, non-invasive methods like neuroimaging, digital technologies, and psychosocial supports.

The estimated funding amounts range from €6 million to €8 million per project, with a total budget of €50 million for this initiative. The application process is structured in two stages: an initial proposal submission due on September 16, 2025, followed by a detailed application for successful candidates due on April 16, 2026.

Successful proposals will demonstrate collaboration, rigorous clinical studies, and stakeholder engagement, adhering to FAIR (Findable, Accessible, Interoperable, Reusable) data principles. The evaluation process aims to be competitive, with success rates estimated between 10% and 39%. Co-funding is typically not required for these lump-sum grants, providing full coverage of eligible costs.

In summary, this funding opportunity is designed to promote collaborative research and innovation efforts aimed at improving interventions for mental, behavioral, and neurodevelopmental disorders, thereby enhancing outcomes for affected individuals while fostering strong partnerships in the scientific community.

The EU's Horizon Europe program is offering funding for research and innovation actions aimed at advancing innovative interventions for mental, behavioural, and neurodevelopmental disorders. This funding opportunity, titled HORIZON-HLTH-2025-03-DISEASE-02-two-stage, falls under Cluster 1 Health and is a two-stage call. The goal is to support activities that contribute to "Tackling diseases and reducing disease burden."

The expected outcomes of funded projects include:

Effective use of state-of-the-art knowledge, data, technologies, tools, methods, best practices, and training by the scientific and clinical communities to develop innovative interventions.
Strengthened collaboration among scientific and clinical communities within the EU, associated countries, and beyond through the exchange of data, knowledge, and best practices.
Wide use of relevant databases and integration with existing infrastructures for data storage and sharing, adhering to FAIR principles.
Informing policymakers, funders, scientific and clinical communities, patient organizations, regulators, and other relevant bodies about research advances and the requirements for widespread implementation of innovative therapeutic interventions and complementary approaches.
Constructive engagement of patients and caregivers in the research process to ensure their needs are met and they tangibly benefit from the interventions.

The scope of the funding opportunity focuses on mental, behavioural, and neurodevelopmental disorders, excluding rare diseases. These disorders include severe depression, anxiety, schizophrenia, psychosis, post-traumatic stress disorder (PTSD), addictive behaviours (drugs, alcohol, gaming), obsessive-compulsive disorder, eating disorders, and autism spectrum disorder. The aim is to address the unmet medical needs associated with these disorders by developing more innovative, safer, and effective therapeutic and relapse-preventing solutions. The call also encourages the development of non-invasive multidisciplinary and/or transdiagnostic approaches such as neurostimulation, neuroimaging, digital solutions, non-pharmaceutical interventions, psychotherapy, and psychosocial support.

Proposals should address most of the following aspects:

Conduct rigorous clinical studies to assess the safety and efficacy of innovative interventions, ensuring adequate cohort sizes and representation of the patient population in terms of age, sex, and ethnicity.
Gain further insight into the mechanisms of action of innovative therapies and complementary approaches through clinical studies, including analyses of imaging, physiological, molecular, biochemical, or omics signatures.
Use and/or develop technologies, including digital technologies like generative AI and wearable technologies, to implement and monitor the long-term efficacy of interventions, manage disorders, and monitor their progression, while ensuring they are bias-free, inclusive, and ethically sound.
Exploit existing data, biobanks, registries, and/or cohorts, and generate new data managed in line with FAIR principles.
Engage all relevant stakeholders, including patients, caregivers, clinicians, counselors, and regulators, to design end-user optimized interventions, applying gender-sensitive and intersectional approaches.
Advance research by leveraging existing and emerging state-of-the-art research infrastructures such as ECRIN, EATRIS, EBRAINS, BBMRI, EuroBioImaging, and the European Genomic Data Infrastructure.
Engage with national public health authorities and regulators to ensure a robust development pathway and further uptake of the intervention.

The participation of start-ups, micro, small, and medium-sized enterprises (SMEs) is encouraged to strengthen their scientific and technological foundations and enhance their innovation potential. Funded projects should liaise with the European Partnership for Brain Health once launched. The topic requires the effective contribution of social sciences and humanities (SSH) disciplines. All projects are strongly encouraged to participate in networking and joint activities, with a budget allocated for attendance to regular joint meetings. Applicants invited to the second stage should provide details of their clinical studies in the dedicated annex.

The total budget for this topic in 2025 is 50,000,000 EUR. The indicative grant contribution ranges from 6,000,000 to 8,000,000 EUR, and it is expected that approximately 7 grants will be awarded.

The call is a two-stage process. The opening date for submissions is May 22, 2025. The deadline for the first stage is September 16, 2025, at 17:00:00 Brussels time. The deadline for the second stage is April 16, 2026, at 17:00:00 Brussels time.

Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme.

Applicants submitting a proposal under the blind evaluation pilot must not disclose their organisation names, acronyms, logos nor names of personnel in the proposal abstract and Part B of their first-stage application.

In summary, this Horizon Europe funding opportunity aims to stimulate research and innovation in the area of mental, behavioural, and neurodevelopmental disorders. It encourages multidisciplinary approaches, the use of advanced technologies, and the active involvement of stakeholders to develop and implement more effective and personalized interventions. The program seeks to improve the lives of patients and caregivers while also strengthening collaboration among researchers and promoting the widespread adoption of best practices. The funding is provided as a lump sum, and the evaluation process includes a blind evaluation pilot in the first stage.

Eligible Applicant Types: The eligible applicant types include startups, micro, small and medium-sized enterprises (SMEs), research institutions, clinical communities, and social sciences and humanities (SSH) experts and institutions. The participation of these entities is encouraged to strengthen scientific and technological foundations, enhance innovation potential, and explore commercial exploitation. The call also welcomes the engagement of all relevant stakeholders, especially patients and patients’ representatives for the disorder, caregivers, clinicians, counselors, regulators, etc.

Funding Type: The funding type is a grant, specifically a HORIZON Lump Sum Grant, under the HORIZON Research and Innovation Actions (HORIZON-RIA).

Consortium Requirement: The opportunity does not explicitly mandate a consortium, but it strongly encourages networking and joint activities, implying that collaborative projects are favored.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes the EU, Associated Countries, and potentially non-EU/non-Associated Countries with specific provisions, as detailed in Annex B of the Work Programme General Annexes and the Horizon Europe Programme Guide. The United States of America is explicitly mentioned as eligible for Union funding.

Target Sector: The target sector is health, specifically focusing on mental, behavioural, and neurodevelopmental disorders. This includes areas such as severe depression, anxiety, schizophrenia, psychosis, post-traumatic stress disorder (PTSD), addictive behaviors (drugs, alcohol, gaming and others), obsessive-compulsive disorder, eating disorders, and autism spectrum disorder. The program aims to advance innovative interventions for these disorders.

Mentioned Countries: United States of America, EU, Associated Countries

Project Stage: The project stage is geared towards clinical studies and the development, validation, and potential implementation of innovative interventions. This includes performing rigorous clinical studies, gaining insights into the mechanisms of action of therapies, developing digital technologies for monitoring efficacy, and engaging with public health authorities for uptake of interventions.

Funding Amount: The funding range is variable, with individual contributions ranging from EUR 6,000,000 to EUR 8,000,000, and EUR 7,000,000 to EUR 8,000,000 depending on the specific topic. The overall budget for the HORIZON-HLTH-2025-03-DISEASE-02-two-stage topic is EUR 50,000,000.

Application Type: The application type is an open call with a two-stage submission process.

Nature of Support: The beneficiaries will receive money in the form of a lump sum grant.

Application Stages: The application process involves two stages. In the first stage, applicants submit a proposal that is evaluated based on Excellence and Impact. If successful, applicants are invited to the second stage, where they provide a more detailed proposal, including details of their clinical studies, which is evaluated based on Excellence, Impact, and Implementation.

Success Rates: The success rates are not explicitly mentioned, but the evaluation process for the first stage aims to select proposals with a total requested budget close to four times the available budget, suggesting a competitive selection process.

Co-funding Requirement: The need for co-funding is not explicitly stated.

This opportunity is a call for proposals under the Horizon Europe Programme, specifically targeting innovative interventions for mental, behavioral, and neurodevelopmental disorders. The goal is to support activities that contribute to tackling diseases and reducing disease burden by fostering the development and implementation of more effective therapeutic and relapse-preventing solutions. The call encourages a multidisciplinary approach, integrating active substances with non-invasive methods like neurostimulation, neuroimaging, and digital technologies. It emphasizes the importance of clinical studies, data sharing, and the involvement of various stakeholders, including patients, caregivers, and regulatory bodies. Eligible applicants include startups, SMEs, research institutions, and SSH experts from the EU, associated countries, and potentially the USA. The funding is provided as a lump sum grant, and the application process involves two stages, with proposals evaluated based on excellence, impact, and implementation. The call aims to improve health outcomes, self-determination, autonomy, and quality of life for individuals affected by these disorders.