Notice of Clarification of the Requirement of Dose Ranging Studies for RFA-MH-17-600 "Early Stage Testing of Pharmacologic or Device-based Interventions for the Treatment of Mental Disorders (R61/R33)"

Notice Number: NOT-MH-17-034

Key Dates
Release Date: June 22, 2017

Related Announcements
RFA-MH-17-600

Issued by
National Institute of Mental Health (NIMH)

Purpose

The purpose of this Notice is to clarify the language concerning dose ranging studies in the R33 phase in RFA-MH-17-600.

It is NIMH’s expectation that the R61 phase should determine the optimal dose/stimulus range for the subsequent trial to be conducted in the R33 phase. A dose ranging study is not required in the R33 phase. Adequate functional target engagement, in relationship to PK and dosing, including establishment of optimal dosing, remain a key criterion of a “go/no-go” decision to move from the R61 to R33 phase.

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

The R33 Phase

Current language:
Pilot studies supported by the R33 phase should be powered for testing the link between the degree of the intervention's target engagement and functional outcomes in a patient population, in a dose ranging study.

Revised Language:
Pilot studies supported by the R33 phase should be powered for testing the link between the degree of the intervention's target engagement and functional outcomes in a patient population.

All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to:

For Pediatric Studies
Margaret Grabb, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3563
Email: mgrabb@mail.nih.gov

For Adult Studies
Mi Hillefors, M.D., Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  301-443-2738
Email: mi.hillefors@nih.gov

For Geriatric Studies
Jovier Evans, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  301-443-6328
Email: jevans1@mail.nih.gov