Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (R61/R33 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for researchers and academic institutions seeking to conduct early-stage clinical testing of pharmacologic or neuromodulatory device-based interventions for mental health disorders. Typically eligible applicants include nonprofit organizations, universities, colleges, hospitals, and other academic research institutions. The R61/R33 mechanism is designed to support high-risk, innovative research transitioning from preclinical or early clinical evidence to clinical trials. A clinical trial is required, and applications must demonstrate strong preliminary data supporting the proposed intervention. Generally, grants are available to organizations with IRB/IND experience and research infrastructure. Applicants should have expertise in clinical trial design and psychiatric/neurological therapeutic development. Geographic scope is nationwide.
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Program description
NIMH requires an experimental therapeutics approach for the development and testing of therapeutic interventions, in which studies both evaluate the clinical effect of an intervention and generate information about the mechanisms underlying a disorder or an intervention response. As part of NIMHs Clinical Trial Pipeline, this NOFO encourages early stage testing of pharmacologic interventions with novel mechanisms of actions or device-based interventions. More specifically, this NOFO is intended to support early stage testing of pharmacologic or device-based interventions using a protocol design where the presumed mechanism of action of the intervention is adequately tested, to provide meaningful information where target modulation yields a dose-dependent neurophysiological/clinical/behavioral effect.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (R&R) form and project narrative
- Detailed research plan with specific aims and methods
- Preliminary data and supporting figures/tables
- Budget and budget justification
- Biographical sketches of key personnel (NIH format)
- Current and pending support documentation
- IRB/IND strategy and regulatory pathway documentation
- Clinical trial protocol or protocol outline (if applicable)
- Letters of institutional support and resource availability
- Detailed timeline with R61-to-R33 milestone criteria
- References and supporting publications
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
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 is eligible to apply for this grant?
Nonprofit organizations, universities, academic medical centers, and other research institutions with research capacity and IRB/IND capabilities can apply. Individual researchers typically apply through their institutional research office.
Is a clinical trial required?
Yes. This funding mechanism specifically requires clinical testing as part of the project scope, differentiating it from purely preclinical research grants.
What is the R61/R33 structure?
The R61 phase provides initial funding for planning and small-scale studies (typically 1-2 years). Upon successful milestone completion, researchers can transition to the R33 phase for larger-scale clinical trials (typically 2-3 years).
How competitive is this funding?
This is highly competitive. NIH peer review evaluates innovation, significance, team qualifications, feasibility, and strength of preliminary data. Expect rigorous scientific scrutiny.
What is the typical funding range?
NIH typically funds R61/R33 mechanisms in the $500K-$2M+ range depending on project scope, though exact amounts vary by specific announcement.
💡 Tips for applicants
- Build strong preliminary data: Reviewers expect robust preclinical or early clinical evidence justifying the transition to human testing. Weak preliminary work is a common rejection reason.
- Clearly articulate the unmet clinical need: Explicitly explain why current treatments are insufficient and how your intervention addresses a gap in mental health care.
- Demonstrate clinical trial expertise: Include team members with experience in trial design, regulatory affairs (FDA pathway), and psychiatric outcome measurement. This is essential for credibility.
- Address feasibility and timeline realistically: NIH reviewers scrutinize whether milestones between R61 and R33 phases are achievable. Overpromising leads to poor scores.
- Detail the neuromodulation or pharmacologic mechanism: Provide clear mechanistic rationale for how your intervention will affect brain function and improve symptoms. Avoid vague theoretical claims.
⚠️ Common mistakes
Applications frequently fail due to insufficient preliminary data—reviewers need convincing evidence from preclinical models or initial human studies before funding clinical trials. Another common issue is underestimating regulatory complexity; applicants often lack detailed FDA/IND strategy or don't address safety monitoring adequately for neuromodulatory devices. A third pitfall is weak milestone definition: the R61-to-R33 transition criteria must be specific, measurable, and realistic, not vague promises of progress.
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