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Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)

US National Institutes of Health (NIH) grant open #PAR-25-179
Response due Oct 15, 2027 · 00:00 UTC

Summary

The National Institutes of Health (NIH) is soliciting R01 grant applications for confirmatory efficacy clinical trials evaluating both non-pharmacological and pharmacological interventions targeting mental disorders. This is a Program Announcement with Review (PAR), meaning applicants must propose and conduct rigorous clinical trials designed to confirm the efficacy of mental health interventions. The opportunity is open for multiple submission cycles between November 2024 and October 2027, reflecting NIH's sustained investment in mental health clinical research.

What they want

Applicants must design and execute confirmatory efficacy clinical trials — either pharmacological or non-pharmacological — for interventions intended to treat or ameliorate mental disorders. Trials must meet NIH's definition of a clinical trial. Research is expected to follow rigorous scientific standards for confirmatory (late-phase) efficacy testing, including appropriate control conditions, sample sizes, outcome measures, and statistical powering to confirm therapeutic efficacy.
Technical requirements
  • Proposed research must meet NIH's definition of a clinical trial
  • Trials must be confirmatory (late-phase) efficacy design
  • Must address pharmacological or non-pharmacological interventions for mental disorders
  • R01 grant mechanism required

How they evaluate

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

Risks & flags

  • Multi-year open window (Nov 2024 – Oct 2027) with multiple submission cycles is standard for NIH PARs — no single-bidder wiring detected
  • No dollar value stated — award sizes are not disclosed in the synopsis, limiting competitive intelligence

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
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.

Confirmatory Efficacy Clinical Trials of N…
Due Oct 15
Onboard ↗