PAR-21-133: First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01 Clinical Trial Required)
Closed
This grant is closed. Who won this program's grants before is below, and similar open grants are at the end of the page. It is in our archive of National Institutes of Health notices from 2021.
National Institutes of Health offered grants to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. Applications closed on October 15, 2024.
From the official notice on Grants.gov, last changed January 17, 2024. Checked November 7, 2026.
- Award amountsNot given on Grants.gov
- Cost sharingNot required
- Funding typeCooperative Agreement
About this NIH notice
- Activity codeU01
- Clinical trialsRequired
- Funded byNIMH
- Median yearly award$809,016
- Typical project length3.5 years
- U01, Research Project Cooperative Agreement. Like an R01, but NIH staff are substantially involved in the work. Other open U01 notices.
Projects funded under PAR-21-133 were run by National Institute of Mental Health (NIMH, 2 projects). Contact the program officer at the institute that fits your project before you apply; the notice lists them.
Application due dates, page limits and budget limits are set in the notice. Read PAR-21-133 in the NIH Guide.
Key dates
| Posted | March 2, 2021 |
|---|---|
| Deadline | October 15, 2024 |
| Archived by Grants.gov | November 14, 2024 |
Who can apply
This opportunity was open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.
All 15 applicant types the notice lists
- 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 (see text field entitled "Additional Information on Eligibility" for clarification)
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Is this a realistic fit?
- Most of the program's money (69% over five years) went to colleges and universities.
- No cost sharing or match is required.
What the grant funds
The purpose of this Funding Opportunity Announcement (FOA) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs, or novel neuromodulatory devices for the treatment of psychiatric disorders in areas of unmet medical need. The FOA will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase II studies of novel agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drugs impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The FOA also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private or other public funding for further clinical development as FDA-approved treatments. A key aspect of this FOA is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development.
Funded under PAR-21-133 so far
NIH funded 2 projects under PAR-21-133 in fiscal 2023 to 2026, at 2 institutions. The median yearly award was $809,016.
| Project | Institution | Fiscal year | Award |
|---|---|---|---|
| Use of alpha-frequency deep transcranial interference stimulation (tIS) to understand and modify temporal dynamics of face emotion recognition and social/affective function. | Columbia University Health Sciences | 2026 | $823,173 |
| Deep Brain Stimulation for Chronic Auditory Hallucinations in Treatment-Resistant Schizophrenia: an early-stage clinical trial | Johns Hopkins University | 2025 | $752,353 |
Who has won Mental Health Research Grants grants before
From fiscal 2021 to 2025, Mental Health Research Grants (93.242) awarded $8.8 billion across 6,785 grant awards, an average of $1.3 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| Yale Univ | Connecticut | 185 | $371 million |
| University of Pittsburgh - of the Commonwealth System of Higher Education | Pennsylvania | 200 | $297 million |
| University of California, Los Angeles | California | 176 | $234 million |
| Icahn School of Medicine at Mount Sinai | New York | 144 | $212 million |
| The Washington University | Missouri | 149 | $211 million |
Applying now
This notice no longer takes applications. Agencies often post the same opportunity again under a new number, so check the program's notices on Grants.gov and the similar open grants below.
The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.
Questions people ask
Is PAR-21-133 still open?
No. It closed on October 15, 2024.
Who can apply for First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01 Clinical Trial Required)?
National Institutes of Health accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. The notice adds further conditions, so read its eligibility section.
What is the deadline for First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01 Clinical Trial Required)?
Closed October 15, 2024. Applications are no longer accepted; the program's newer notices are on this page when there are any.
Who has been funded under PAR-21-133?
NIH RePORTER lists 2 projects funded under PAR-21-133 in fiscal 2023 to 2026, at 2 institutions. The most were at Columbia University Health Sciences, Johns Hopkins University.
Who has won Mental Health Research Grants grants before?
The largest recipients over five fiscal years were Yale Univ, University of Pittsburgh - of the Commonwealth System of Higher Education, University of California, Los Angeles. The program made 6,785 awards worth $8.8 billion in that time.
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