Notice of Intent to Publish a Funding Opportunity Announcement for Exploratory Clinical Trials of Novel Interventions for Mental Illnesses (R21/R33)

Notice Number: NOT-MH-13-022

Key Dates
Release Date: September 12, 2013
Estimated Publication Date of Announcement: October 20, 2013
First Estimated Application Due Date: February 16, 2014
Earliest Estimated Award Date: December 1, 2014
Earliest Estimated Start Date: December 1, 2014

Related Announcements


Issued by
National Institute of Mental Health (NIMH)


The National Institute of Mental Health intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for research on intervention development trials for mental illnesses, including behavioral, device and pharmacologic interventions. 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 Fall 2013, with an expected application due date in Winter 2014.

This FOA will utilize the R21/R33 activity code. Details of the planned FOA are provided below.

Research Initiative Details

NIMH is now focusing on an experimental medicine approach to evaluating novel interventions for mental illnesses. This strategy is designed to increase the value of the public investment in early clinical trials by ensuring informed, data-driven decisions at an early stage. Paul et al have described the need for a new paradigm for drug development based on “fast-fail”, i.e., focusing on proof of concept prior to proceeding to expensive Phase III trials [Paul SM, Mytelka DS, Dunwiddie CT, et al., How to improve R&D productivity: The pharmaceutical industry’s grand challenge. Nature Reviews Drug Discovery 9:203-214 (2010)]. This paradigm calls for small trials, focused on proof-of-concept “experimental medicine” paradigms, to demonstrate target engagement, safety, and early signs of efficacy.

This FOA will focus on supporting intervention testing, using this new paradigm. The FOA will detail the requirements for exploratory clinical trials, with emphasis on experimental medicine-based approaches for behavioral, device, and pharmacologic studies.

This Notice encourages investigators with expertise and insights into this area of science to begin to consider applying for this new FOA.



Please direct all inquiries to:

NIMH Referral Office
National Institute of Mental Health