Notice to Clarify the Funding Opportunities for Testing of Pediatric Subjects in Early Stage Trials to Assess Rapid-acting Interventions that have the Potential to Reduce Severe Suicide Risk

Notice Number: NOT-MH-20-033

Key Dates
Release Date: February 10, 2020

Related Announcements
RFA-MH-20-345

Issued by
National Institute of Mental Health (NIMH)

Purpose

NIMH is issuing this Notice to clarify the funding opportunity announcements (FOAs) that are available to researchers when testing pediatric subjects in early stage trials to assess rapid-acting interventions that have the potential to reduce severe suicide risk.

The funding opportunity RFA-MH-20-345 encourages applications designed to support later stage trials to assess rapid-acting interventions that have the potential to reduce severe suicide risk for different age ranges (pediatric through geriatric). The FOA includes a series of prerequisites including “Existing data are available to inform dosing (i.e., clear data exist regarding a dose range that can safely be administered with potential for efficacy)”. Considering these criteria, it is unlikely that a novel pharmacologic agent or brain stimulation device would have the appropriate level of established data on dosing to enable the applicant to design further efficacy trials as requested under this FOA. Therefore, applicants interested in testing pharmacologic agents or brain stimulation devices in pediatric populations as rapid acting interventions without established prerequisite data should direct their applications to the NIMH FOAs that supporting early stage dosing designs.

Specifically, for brain stimulation studies and pharmacologic agent testing, including the testing of ketamine or other hallucinogens, applications should be directed to one of the following: a) PAR-18-427 (U01), and follow the additional criteria for pediatric pharmacologic testing in NOT-MH-17-039 or b) RFA-MH-18-702 (R61/R33).

Inquiries

Please direct all inquiries to:

Margaret C. Grabb, Ph.D.
Division of Translational Research
Telephone: 301-443-3563
Email: mgrabb@mail.nih.gov