Notice Number: NOT-MH-17-039

Key Dates
Release Date: July 24, 2017

Issued by
National Institute of Mental Health (NIMH)

Purpose

NIMH is issuing this Notice to highlight its interest in supporting early stage pediatric clinical trials to investigate novel mechanism of action pharmacologic agents for the treatment of psychiatric symptoms. Given this interest, the NIMH is encouraging the submission of applications for such trials through the recently released funding opportunity announcement entitled, First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01).

There are few pediatric trials that investigate drug candidates in psychiatry. Yet these trials are critical for evaluating safety, tolerance, efficacy and optimal dosing in developing children. Molecular targets most relevant to the developing central nervous system (CNS) may be different from ones appropriate in treating psychiatric disorders in adults, and so it is important to establish a pediatric trial model where drug candidates can be tested safely, even if the drug candidate has not received formal approval in any psychiatric indication in adults.

This notice is intended to highlight NIMH's support of early stage drug candidate trials through pediatric pharmacokinetic/pharmacodynamic (PK/PD) bridging studies. This PK/PD experimental medicine framework, which measures both drug levels and CNS functional effects, is designed to objectively inform if the drug candidate has adequate brain exposure without side effects and to inform whether or not further efficacy trials are warranted.

Examples of drug candidates that have a safety record for testing in pediatrics can be found here: https://ncats.nih.gov/ntu/assets/2017#Pediatric_Indications Note: not all of the compounds would be appropriate for CNS use.

Prior to submission of the research grant application, Investigational New Drug (IND) applications should be submitted to the Food and Drug Administration (FDA) to confirm that rodent studies are not required by the FDA, prior to initiating a pediatric clinical trial.

Given the diversity of expertise needed to conduct pediatric drug trials, it is required that a pediatric pharmacologist and pediatric psychiatrist would jointly participate in the design and implementation of the trial(s). Additionally, it is required that the investigator would work with a Contract Research Organization or a coordinating center with expertise in first in pediatric PK/PD bridging studies for regulatory submissions. Investigators are encouraged to consider partnering with the Clinical and Translational Science Award (CTSA) Trial Innovation Network by submitting a proposal to the Trial Innovation Network.


For other NIMH funding opportunities that may become available in the coming months, please visit the NIMH Funding Opportunities page: https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml

Inquiries

NIMH strongly recommends potential applicants contact program staff listed below, to ensure the project fits NIMH priority research areas:

Margaret C. Grabb, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3563
Email: [email protected]