Notice of Intent to Publish a Funding Opportunity Announcement for Pilot Effectiveness Trials for Rapid-Acting Interventions for Severe Suicide Risk (R01 Clinical Trial Required)

Notice Number: NOT-MH-19-044

Key Dates

Release Date: October 11, 2019
Estimated Publication Date of Funding Opportunity Announcement: December 14, 2019
First Estimated Application Due Date: February 25, 2020
Earliest Estimated Award Date: September 01, 2020
Earliest Estimated Start Date: September 01, 2020

Related Announcements
None

Issued by
National Institute of Mental Health (NIMH)

Purpose

The NIMH intends to promote a new initiative through a Funding Opportunity Announcement (FOA) that will solicit applications to test the feasibility of rapid-acting interventions to reduce suicide risk through clinical trials that are based in appropriate/specialized healthcare settings (e.g., emergency departments, psychiatric inpatient units, settings that meet Risk Evaluation and Mitigation Strategy approaches).

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in December 2019 with an expected application due date in February 2020.

This FOA will utilize the R01 activity code. Details of the planned FOA are provided below.

Research Initiative Details

The continuing rise in suicide deaths and nonlethal suicide attempts, often associated with underlying mental and substance use disorders, remain pressing public health challenges. Up to 80% of suicide decedents visit health care settings in the year before death, making the delivery of effective interventions in healthcare settings a top priority. Despite advances in psychiatric treatments over the past several decades, and a growing list of effective psychosocial interventions that reduce repeat suicide attempts, there remain few evidence-based interventions that have been tested for their rapid-onset benefits for reducing suicide risk. Building the evidence base for the use of rapid-acting treatments has the potential to ‘jumpstart’ the recovery trajectory.

The ultimate goal of this initiative is to identify scalable approaches that can be integrated into care for potential near-term impact. Accordingly, NIMH encourages research on strategies that involve targeted use of existing, promising interventions (including pharmacological, psychosocial/behavioral, and device-based approaches), alone or in combination, with potential for rapidly reducing acute suicide risk. Recognizing that sustained recovery may require longer treatment periods, rapid-acting interventions may need to be accompanied by other interventions (in combination or in sequence) over longer treatment periods, to ensure durable recovery.

This Notice encourages investigators to consider developing applications that build upon extant findings (e.g., evidence regarding efficacy, dosing, durability of effects, patient selection/matching, safety) to refine and test promising approaches that can be feasibly delivered in acute-care and appropriate outpatient care settings. Principal outcomes of interest include the reduction of suicide events, including ideation, attempts, death, and potential reductions in the use of high-resource services (e.g., emergency care visits, hospitalization).

This Notice encourages investigators with expertise and insights into this area of mental disorders and suicide prevention clinical trials to begin to consider applying for this new FOA.

Funding Information

Estimated Total Funding TBD
Expected Number of Awards Up To 6
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.242

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government
Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Matthew Rudorfer, M.D.
National Institute of Mental Health (NIMH)
(301) 443-1111
mrudorfe@mail.nih.gov