Accelerating Medicines Partnership Schizophrenia (AMP SCZ): Clinical High Risk for Psychosis Clinical Trial Network (U01 Clinical Trial Required) | RFA MH 24 150

Opportunity Information: Apply for RFA MH 24 150

The Accelerating Medicines Partnership Schizophrenia (AMP SCZ): Clinical High Risk for Psychosis Clinical Trial Network funding opportunity (RFA-MH-24-150) is an NIH cooperative agreement (U01) focused on running a proof-of-pharmacology (PoP) clinical trial in people at clinical high risk (CHR) for psychosis. The core purpose is to take a selected subset of drug development tools already being evaluated in the broader AMP SCZ observational study and put them to work in an interventional setting, testing whether those tools can detect meaningful biological and/or clinical signals after treatment with one or more selected compounds over a relatively short study window of about 12 to 16 weeks. In practice, this means building and operating a CHR Clinical Trial Network that can implement a rigorously designed, time-limited trial intended to show measurable target engagement and/or mechanistic effects, alongside changes in symptoms or risk-related clinical outcomes, rather than a long, definitive efficacy trial.

A central feature of the project is measurement performance: the PoP trial is explicitly designed to assess how well key clinical and biomarker measures behave in this context. The opportunity calls out the PSYCHS (a structured clinical assessment used in the psychosis-risk space) as a primary instrument to be evaluated, along with other clinical outcome measures and biological measures. The expectation is that the trial will generate evidence about sensitivity to change, feasibility, and signal detection across these tools in CHR participants. In other words, the network is not only testing a compound; it is also stress-testing a measurement toolbox meant to accelerate decision-making in early psychosis drug development.

The compounds chosen for testing are expected to be mechanistically grounded. NIH is looking for candidate compound(s) that act on a pathophysiologically relevant mechanism for schizophrenia and related psychotic disorders, with a plausible ability to produce detectable changes on biological readouts and clinical measures within the 12 to 16 week timeframe. This emphasis on a detectable near-term signal aligns with PoP logic: demonstrating that a drug engages the intended pathway and produces measurable downstream effects quickly enough to inform go/no-go decisions and guide later-stage trials. The network structure implied by the announcement supports standardized implementation across sites, consistent training and administration of PSYCHS and other assessments, harmonized biospecimen or biomarker collection where relevant, and coordinated trial operations suitable for a cooperative agreement mechanism where NIH has substantial programmatic involvement.

From an administrative standpoint, this opportunity sits in the NIH health research category (CFDA 93.242) and uses the U01 cooperative agreement mechanism, which typically indicates a more collaborative relationship with NIH staff than a standard investigator-initiated grant. Eligible applicants are broad across U.S.-based organizational types, including state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments and other tribal organizations; public housing/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses) and small businesses; and other domestic entities that meet NIH eligibility rules. The notice also highlights additional eligible institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and U.S. territories or possessions.

Foreign participation is clearly restricted. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply, and foreign components as defined by the NIH Grants Policy Statement are not allowed. The opportunity was created on July 12, 2023, with an original closing date of October 17, 2023. Overall, the grant is aimed at accelerating schizophrenia therapeutics development by establishing a CHR-focused clinical trial network capable of running short, mechanistically informed PoP trials while simultaneously validating and refining the clinical and biological tools needed to detect meaningful signals in this population.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Accelerating Medicines Partnership Schizophrenia (AMP SCZ): Clinical High Risk for Psychosis Clinical Trial Network (U01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
• This funding opportunity was created on 2023-07-12.
• Applicants must submit their applications by 2023-10-17. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA MH 24 150

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