European UnionDeadline PassedNon-profit, Private Business, Research Institution, Public Institution, Other
Advancing innovative interventions for mental, behavioural and neurodevelopmental disorders
HORIZON-HLTH-2025-03-DISEASE-02-two-stage
Funding Amount
€6.0M - €8.0M
Deadline
16/09/2025
Eligible Organization Types
Non-profit, Private Business, Research Institution, Public Institution, Other
Trusted by
What is the Advancing innovative interventions for mental, behavioural and neurodevelopmental disorders Call?
Grant Description
Support for research and innovation actions to develop and clinically validate innovative therapeutic and relapse-preventing interventions and complementary multidisciplinary approaches for mental, behavioural and neurodevelopmental disorders. The call addresses high unmet medical needs, aims to generate mechanistic insights, foster data sharing, involve stakeholders and patients, leverage digital and research infrastructure, and inform policy and clinical practice.
Required Results for Successful Funding
Expected Outcomes
Proposals should deliver results that:
1. Enable scientific and clinical communities to effectively use state-of-the-art knowledge, data, technologies, tools, methods, best practices and trainings to support the development of innovative interventions with lasting patient benefit.
2. Strengthen collaboration across the EU, Associated Countries and beyond through enhanced exchange of data, knowledge and best practices.
3. Promote widespread adoption and integration of relevant databases into existing infrastructures, ensuring storage and sharing of collected data according to FAIR principles to facilitate further reuse.
4. Inform policymakers, funders, clinical and scientific bodies, patient organisations and regulators about research advances and the requirements for the implementation of innovative therapeutic and complementary approaches.
5. Achieve constructive engagement of patients and caregivers in research, ensuring interventions address their needs and translate into tangible patient benefits.
1. Enable scientific and clinical communities to effectively use state-of-the-art knowledge, data, technologies, tools, methods, best practices and trainings to support the development of innovative interventions with lasting patient benefit.
2. Strengthen collaboration across the EU, Associated Countries and beyond through enhanced exchange of data, knowledge and best practices.
3. Promote widespread adoption and integration of relevant databases into existing infrastructures, ensuring storage and sharing of collected data according to FAIR principles to facilitate further reuse.
4. Inform policymakers, funders, clinical and scientific bodies, patient organisations and regulators about research advances and the requirements for the implementation of innovative therapeutic and complementary approaches.
5. Achieve constructive engagement of patients and caregivers in research, ensuring interventions address their needs and translate into tangible patient benefits.
Funded areas
Scope Requirements
• Target disorders: Non-rare mental, behavioural and neurodevelopmental disorders (ICD-11 Chapter 6) including severe depression, anxiety, schizophrenia, psychosis, PTSD, addictions, OCD, eating disorders, autism spectrum disorder. Rare diseases (≤1 per 2 000 EU population) are excluded.
• Interventions must combine an active-substance product with a complementary multidisciplinary approach.
• Clinical studies must:
– Demonstrate rigorous design with adequate cohorts, representative of age, sex and ethnicity.
– Yield mechanistic insights via imaging, molecular/omics, biochemical and physiological analyses, supporting personalised medicine and surrogate endpoint development.
• Digital and wearable technologies: develop or deploy AI-driven, unobtrusive, home-based monitoring tools that are bias-free, inclusive and ethically sound.
• Data: exploit existing data sources (biobanks, registries, cohorts), generate new data, manage all according to FAIR principles.
• Stakeholder engagement: involve patients, representatives, caregivers, clinicians, counsellors and regulators in intervention design; apply gender-sensitive and intersectional methods.
• Infrastructure use: leverage state-of-the-art research infrastructures (ECRIN, EATRIS, EBRAINS, BBMRI, EuroBioImaging, European Genomic Data Infrastructure) and EU project outputs.
• Regulatory alignment: collaborate with public health authorities and regulators for seamless development and uptake.
• Industry involvement: include start-ups, SMEs to strengthen scientific/technological foundations and commercial pathways.
• SSH integration: embed social sciences and humanities expertise to enhance societal relevance.
• Networking: allocate budget for joint activities and regular meetings; specific activities to be defined in grant agreement.
• Stage-two annex: submit detailed clinical study protocols using the prescribed template.
• Interventions must combine an active-substance product with a complementary multidisciplinary approach.
• Clinical studies must:
– Demonstrate rigorous design with adequate cohorts, representative of age, sex and ethnicity.
– Yield mechanistic insights via imaging, molecular/omics, biochemical and physiological analyses, supporting personalised medicine and surrogate endpoint development.
• Digital and wearable technologies: develop or deploy AI-driven, unobtrusive, home-based monitoring tools that are bias-free, inclusive and ethically sound.
• Data: exploit existing data sources (biobanks, registries, cohorts), generate new data, manage all according to FAIR principles.
• Stakeholder engagement: involve patients, representatives, caregivers, clinicians, counsellors and regulators in intervention design; apply gender-sensitive and intersectional methods.
• Infrastructure use: leverage state-of-the-art research infrastructures (ECRIN, EATRIS, EBRAINS, BBMRI, EuroBioImaging, European Genomic Data Infrastructure) and EU project outputs.
• Regulatory alignment: collaborate with public health authorities and regulators for seamless development and uptake.
• Industry involvement: include start-ups, SMEs to strengthen scientific/technological foundations and commercial pathways.
• SSH integration: embed social sciences and humanities expertise to enhance societal relevance.
• Networking: allocate budget for joint activities and regular meetings; specific activities to be defined in grant agreement.
• Stage-two annex: submit detailed clinical study protocols using the prescribed template.
Additional Conditions for Applicants
Special Conditions
• Grant type: Lump sum model under Horizon Europe Decision of 7 July 2021; eligible costs defined by lump sum rules.
• Submission: two-stage call; first stage blind evaluation pilot—applicants must anonymise organisation names, acronyms and personnel in abstracts and Part B.
• Evaluation thresholds: Stage 1 requires scores ≥4 for Excellence and Impact; Stage 2 requires scores ≥4 for Excellence, Impact, Implementation (cumulative ≥12).
• Eligibility: entities from Horizon Europe Eligible Countries plus US legal entities; see Annex B and Programme Guide.
• Technical restrictions: projects using satellite data must prioritise Copernicus/Galileo-EGNOS; high-risk suppliers of mobile network equipment and their affiliates are excluded.
• Templates & forms: use standard HE RIA application/evaluation forms, detailed budget table, clinical studies annex template, and call-specific instructions.
• Budgeting: include dedicated costs for networking and meetings; no need to pre-detail joint activities.
• Liaison requirement: all funded projects must liaise with the European Partnership for Brain Health (topic HORIZON-HLTH-2025-02-DISEASE-01) once active.
• SSH requirement: effective contribution of SSH disciplines and experts is mandatory.
• Data management: compliance with FAIR principles as per Work Programme introduction.
• Use of research infrastructures and synergies: encouraged across Horizon Europe clusters and with EU4Health, HERA, ERA4Health partnerships.
• Submission: two-stage call; first stage blind evaluation pilot—applicants must anonymise organisation names, acronyms and personnel in abstracts and Part B.
• Evaluation thresholds: Stage 1 requires scores ≥4 for Excellence and Impact; Stage 2 requires scores ≥4 for Excellence, Impact, Implementation (cumulative ≥12).
• Eligibility: entities from Horizon Europe Eligible Countries plus US legal entities; see Annex B and Programme Guide.
• Technical restrictions: projects using satellite data must prioritise Copernicus/Galileo-EGNOS; high-risk suppliers of mobile network equipment and their affiliates are excluded.
• Templates & forms: use standard HE RIA application/evaluation forms, detailed budget table, clinical studies annex template, and call-specific instructions.
• Budgeting: include dedicated costs for networking and meetings; no need to pre-detail joint activities.
• Liaison requirement: all funded projects must liaise with the European Partnership for Brain Health (topic HORIZON-HLTH-2025-02-DISEASE-01) once active.
• SSH requirement: effective contribution of SSH disciplines and experts is mandatory.
• Data management: compliance with FAIR principles as per Work Programme introduction.
• Use of research infrastructures and synergies: encouraged across Horizon Europe clusters and with EU4Health, HERA, ERA4Health partnerships.
Important dates
Open from: 22/05/2025
Deadline:16/09/2025
Application period has ended
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