Notice Number: NOT-MH-17-034

Key Dates
Release Date: June 22, 2017

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: [email protected]

For Adult Studies
Mi Hillefors, M.D., Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  301-443-2738
Email: [email protected]

For Geriatric Studies
Jovier Evans, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  301-443-6328
Email: [email protected]