Establishing Pediatric CNS Pharmacodynamic Measures as Tools to Enable Psychiatric Indications in Adolescents
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for NIH-funded research on pediatric pharmacodynamics and psychiatric treatment in adolescents. Eligible applicants include research institutions, academic medical centers, and organizations with active research programs. Principal investigators must have doctoral degrees and demonstrated research experience. Projects should focus on developing biomarkers and measurement tools for psychiatric drug development in young populations.
Geographic scope is U.S.-wide, though some funding prioritizes research that will benefit underserved youth populations. Eligible activities include basic research, clinical studies, method development, and validation of pharmacodynamic measures.
Applicants must have institutional research infrastructure and IRB approval capacity. Organizations must be able to manage federal grants and maintain compliance with NIH regulations.
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Key dates
- Sep 12, 2025 Applications open
- Feb 13, 2026 Application deadline
- Dec 1, 2026 Award announced
- Dec 1, 2026 Project start
Program description
The National Institute of Mental Health (NIMH) seeks research that helps determine the best dosing strategies when testing new psychiatric medications in children and adolescents with serious mental illnesses.This NOFO will focus on developing and refining central nervous system (CNS) tools and models that can show how medications affect the brain in young people. These tools might include functional brain imaging methods like EEG or fMRI, as well as digital health measures or cognitive assessments. Studies are encouraged that explore how dosing impacts drug exposure (pharmacokinetics) and related CNS functional effects (pharmacodynamics). The overall goal is to improve the safety and effectiveness of pediatric clinical trials by developing pediatric pharmacodynamic measures, to associate pharmacodynamic data with pharmacokinetic data, and to establish associated models. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Researchers with expertise in pediatric psychiatry, neuroimaging, pediatric clinical pharmacology, clinical trials, or related fields are encouraged to consider applying to the new NOFO.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R)
- Research Plan (Specific Aims, Significance, Innovation, Approach)
- Biographical Sketches (NIH format)
- Budget and Budget Narrative
- IRB approval or approval letter
- Letters of Support from clinical partners
- Preliminary Data Appendix
Program contact
- 👤 Margaret C. Grabb, Ph.D.
- 📧 mgrabb@mail.nih.gov
- 📞 301-443-3563
Funding track record
Recent awards under CFDA 93.242 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$78,262,050
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$75,056,208
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$74,756,329
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$64,705,159
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$63,991,707
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$54,214,022
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$48,653,752
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$38,895,082
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$38,475,557
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$35,940,675
Top States by Funding
- CA 15 awards $408.1M
- MA 9 awards $230.5M
- NY 6 awards $184.2M
- CT 4 awards $183.5M
- WA 4 awards $174.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.242). How funding has trended year over year.
| 2024 | $1,722,300,004 | |
| 2025 | $1,726,864,191 | |
| 2026 est. | $99,221,272 |
FAQ
Who can serve as a principal investigator on this grant?
PIs must hold a Ph.D., M.D., or equivalent terminal research degree. They should demonstrate prior successful research or publication record relevant to pediatric pharmacology.
What are the main research activities this grant supports?
Eligible work includes developing pharmacodynamic biomarkers, validating measurement tools, conducting clinical studies in adolescents, and supporting psychiatric drug development research.
Are there restrictions on working with adolescent subjects?
Yes. Studies must have IRB approval and follow FDA pediatric research guidelines. Informed assent and parental consent are required.
How competitive is this funding?
NIH biomedical research grants are highly competitive. Fundable applications typically have preliminary data, innovation, and experienced research teams.
What is the typical funding range?
This depends on the specific NIH mechanism (R01, R21, etc.). Typically ranges from $150,000 to $500,000+ annually over 3-5 years.
💡 Tips for applicants
- Establish preliminary data first showing feasibility of your pharmacodynamic measures or biomarker approach.
- Clearly explain how your tool advances psychiatric drug development for adolescents beyond existing methods.
- Partner with a clinical site experienced in pediatric psychiatric research and IRB approval processes.
- Include a biostatistician and pharmacologist with adolescent research experience on your team.
- Address regulatory pathway (FDA guidance) and how your measures support drug labeling or clinical trials.
⚠️ Common mistakes
Applications lack preliminary data supporting the pharmacodynamic measure's validity. Proposals fail to clearly explain clinical or developmental rationale specific to adolescents. Applicants underestimate complexity of IRB approval and informed consent/assent requirements for pediatric studies.
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