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Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (R61/R33 Clinical Trial Required)

US National Institutes of Health grant open #PAR-25-184
Response due Oct 15, 2027 · 00:00 UTC

Summary

The National Institutes of Health (NIH) is soliciting applications for early-stage clinical testing of pharmacologic or neuromodulatory device-based interventions targeting the treatment of mental disorders. This is a two-phase R61/R33 grant mechanism requiring a clinical trial. The R61 phase supports early milestone-driven testing, while the R33 phase supports expanded development contingent on R61 milestones being met. The opportunity is open for a multi-year window from late 2024 through October 2027.

What they want

Applicants must propose and conduct early-stage clinical trials evaluating pharmacologic agents or neuromodulatory device-based interventions for the treatment of mental disorders. The R61 phase involves early feasibility/milestone testing, and the R33 phase involves expanded clinical evaluation. Both phases require a clinical trial as defined by NIH. Proposals must adhere to NIH grant application requirements under Program Announcement with Review (PAR) number PAR-25-184.
Technical requirements
  • Must propose a clinical trial as defined by NIH
  • Intervention must be pharmacologic or neuromodulatory device-based
  • Must target treatment of mental disorders
  • R61 phase must include milestone-driven early feasibility testing
  • R33 phase is contingent on successful completion of R61 milestones

How they evaluate

Submission: Grants.gov federal grants portal (electronic submission)

Risks & flags

  • No dollar value or award ceiling is stated — budget expectations are unclear
  • Multi-year open window (2024–2027) may result in rolling competition with limited visibility into award timing
  • Highly specialized scope (neuromodulatory devices + mental disorders) may implicitly favor well-resourced academic medical centers or established NIH grantees

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541711
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Early Stage Testing of Pharmacologic or Ne…
Due Oct 15
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