Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (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 research institutions conducting early-stage clinical testing of pharmacologic treatments or neuromodulatory device-based interventions for mental health disorders. The NIH R33 mechanism supports clinical trial research with preliminary data demonstrating promising therapeutic potential. Eligible applicants include academic medical centers, research hospitals, clinical research organizations, and nonprofit research institutions with 501(c)(3) status and relevant clinical trial infrastructure. Studies must involve human subjects and meet FDA requirements for investigational drugs or devices. Applicants should have institutional capacity to conduct rigorous clinical trials, including IRB approval capability and qualified clinical research staff. Geographic scope is United States and U.S. territories, with priority given to research addressing unmet mental health treatment needs.
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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
- NIH Form SF-424 (R&R) Application for Federal Assistance
- Project Narrative (research strategy section describing preliminary data, clinical trial protocol, and justification)
- Detailed Budget and Budget Justification (including personnel, equipment, supplies, travel, and clinical trial costs)
- Biosketches for key personnel (project director, biostatistician, clinical coordinators)
- Institutional commitment letter(s) documenting clinical trial infrastructure and IRB approval capability
- Letters of support from clinical sites or recruitment partners
- Data Safety Monitoring Plan or reference to external DSMB
- IRB approval or conditional approval documentation
- Letters of support from industry partner (if applicable, with conflict of interest disclosure)
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 an R33 clinical trial grant?
Typically academic institutions, medical centers, research hospitals, and 501(c)(3) nonprofit organizations with documented clinical research infrastructure and IRB approval capabilities. Individual researchers must have institutional sponsorship.
What is the timeline for R33 clinical trial development?
The R33 is designed for early-stage clinical testing. Most budgets support 2-4 years of clinical trial conduct, allowing time for recruitment, treatment delivery, and preliminary data analysis.
Can industry partners collaborate on this grant?
Yes, industry can be a collaborator or subcontractor. However, the primary applicant organization must be a 501(c)(3) nonprofit or government entity. Industry must disclose financial interests and potential conflicts of interest.
How competitive is this grant program?
Very competitive. Success rates for NIH R33 grants typically range from 15-25%. Applications require strong preliminary data, well-designed clinical protocols, realistic timelines, and demonstrated institutional commitment.
What is the typical funding range?
R33 awards commonly range from $250,000 to $750,000 total costs per year, depending on study complexity, sample size, and geographic scope. Larger multi-site trials may exceed these ranges.
💡 Tips for applicants
- Lead with your preliminary data: NIH R33 reviewers expect solid Phase 1/2 findings or strong mechanistic evidence justifying the transition to clinical trial. Clearly quantify effect sizes, safety profiles, or biomarker changes.
- Build a strong clinical team: Include experienced clinical trial coordinators, biostatisticians, and clinicians with published track records in mental health research. Detail their specific roles and relevant prior trial experience.
- Address recruitment and retention realistically: Specify your recruitment strategy, target population characteristics, inclusion/exclusion criteria, and realistic retention rates. Provide letters of support from clinical sites or partner organizations if using multiple centers.
- Design for FDA compliance and safety: Clearly describe regulatory pathway (IND application, IDE exemption, or 510(k) status). Detail your data safety monitoring plan, adverse event reporting procedures, and stopping rules if applicable.
- Justify your outcome measures: Use validated, clinically meaningful endpoints. Explain why your primary and secondary outcomes align with FDA guidance and current clinical practice standards for your target mental health condition.
⚠️ Common mistakes
Applications often fail because they lack sufficient preliminary safety and efficacy data to justify clinical trial investment, or they propose unrealistic recruitment and retention timelines without adequate site partnerships. Reviewers also frequently reject proposals with poorly designed safety monitoring plans, inadequate team expertise in clinical trial conduct, or failure to address regulatory pathway and FDA requirements for the investigational intervention.
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