Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required) | PAR 25 179

Frequently Asked Questions (FAQs)

What is the name and number of this funding opportunity?

This is an NIMH (NIH) R01 funding opportunity for confirmatory efficacy clinical trials. The Funding Opportunity Number (FON) is PAR-25-179.

Which agency is offering this grant?

The grant is offered by the National Institute of Mental Health (NIMH), which is part of the National Institutes of Health (NIH).

What type of grant mechanism is used?

The funding instrument is an NIH Research Project Grant (R01).

Is a clinical trial required for this opportunity?

Yes. A clinical trial is required under this notice.

What is the main goal of this opportunity?

The goal is to support confirmatory efficacy clinical trials of interventions for mental disorders in adults and children, moving interventions beyond early testing into more definitive studies that can establish whether an intervention works under well-controlled conditions.

What stage of research is this opportunity intended to support?

This program is positioned within NIMH's clinical trials pipeline and is intended for interventions that are ready to move beyond early testing into confirmatory efficacy trials.

What does "confirmatory efficacy clinical trial" mean in this context?

Based on the provided description, it refers to a more definitive, well-controlled clinical trial designed to determine whether an intervention works, rather than an early or exploratory test.

What mental health populations are in scope (adults, children, or both)?

Both adults and children are in scope.

What kinds of needs should proposed interventions address?

The opportunity emphasizes unmet therapeutic needs in mental health. This includes gaps where current treatments are insufficient, unavailable, or do not work well for certain populations or settings.

What is NIMH's "experimental therapeutics approach" and why does it matter here?

NIMH emphasizes the experimental therapeutics approach, meaning studies should do more than measure symptom improvement. Applicants are expected to test a clear, scientifically grounded mechanism of action by identifying an intervention target and designing the trial to determine whether the intervention engages that target and whether target engagement is meaningfully related to clinical improvement.

What is an "intervention target" in this opportunity?

An intervention target is a cognitive, behavioral, neural circuit, physiological, or social process linked to the disorder that the intervention is intended to engage or change.

Do applications need to measure both clinical outcomes and mechanism-related outcomes?

Yes. The description indicates that trials should measure mechanism-relevant outcomes (to show target engagement) alongside clinical endpoints, and generate knowledge linking target engagement to clinical improvement.

What does it mean that NIMH does not want a "black box" trial?

It means the trial should not only ask whether the intervention works, but also test how it works by evaluating whether it engages an identified target and how that engagement relates to clinical outcomes.

Are both pharmacological and non-pharmacological interventions allowed?

The title references both non-pharmacological and pharmacological interventions, but the provided description emphasizes non-pharmacological therapeutic and preventive interventions.

What types of non-pharmacological interventions are highlighted as examples?

Examples include psychotherapies, behavioral interventions, digital or technology-based interventions, neurostimulation or device-based strategies, services and systems interventions, caregiver- or family-based programs, and preventive interventions designed to reduce risk or delay onset.

Are preventive interventions included, or only treatments?

Preventive interventions are included, specifically those designed to reduce risk or delay onset.

Does this opportunity focus on efficacy or effectiveness?

It focuses on confirmatory efficacy under well-controlled conditions, as described.

What is the CFDA listing for this opportunity?

The opportunity is categorized as discretionary health funding with CFDA 93.242.

Is there an award ceiling stated in the provided information?

No. The provided text does not specify an award ceiling.

Is the expected number of awards stated in the provided information?

No. The provided text does not state the expected number of awards.

When is the closing date?

The original closing date listed is October 15, 2027.

Does the long closing date mean applications can be submitted over multiple due dates?

The description indicates a multi-year window during which applications may be accepted on relevant due dates, consistent with how many NIH program announcements operate.

Who is eligible to apply?

Eligibility is broad and includes many organization types, including various government entities, institutions of higher education (public and private), nonprofits (with and without 501(c)(3) status, other than institutions of higher education), for-profit organizations (including small businesses and other for-profits), and other eligible entities depending on NIH rules.

Are state and local governments eligible?

Yes. Eligible applicants include state governments; county, city, or township governments; special district governments; and independent school districts.

Are universities and colleges eligible?

Yes. Public and state-controlled institutions of higher education and private institutions of higher education are eligible.

Are nonprofits eligible, including those without 501(c)(3) status?

Yes. Nonprofits with and without 501(c)(3) status (other than institutions of higher education) are listed as eligible.

Are for-profit entities eligible?

Yes. For-profit organizations are eligible, including small businesses and other for-profits that are not small businesses.

Are Tribal governments and Tribal organizations eligible?

Yes. Federally recognized Native American tribal governments are eligible, and tribal organizations that are not federally recognized governments are also listed.

Are housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are included as eligible applicants.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly called out as additional eligible applicants.

Are minority-serving institutions specifically noted as eligible?

Yes. The opportunity explicitly calls out Alaska Native and Native Hawaiian Serving Institutions; AANAPISIs; Hispanic-serving Institutions; HBCUs; and Tribally Controlled Colleges and Universities (TCCUs).

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are listed among additional eligible applicants.

Are non-U.S. (foreign) organizations eligible?

Yes. The opportunity states that non-U.S. entities (foreign organizations) are eligible.

What kinds of applications are likely to be competitive based on the description?

Competitive applications will typically present a strong scientific rationale for the intervention and its target, use a trial design capable of producing clear efficacy conclusions, incorporate measures demonstrating target engagement and linking it to clinical outcomes, and address important unmet mental health needs for children, adolescents, and/or adults.

What is the key takeaway for investigators planning to apply?

The opportunity is aimed at teams ready to run rigorous, mechanism-informed confirmatory efficacy trials for mental health interventions, with a clear target, evidence of target engagement, and a demonstrated connection between target engagement and clinical improvement.