Skip to content

Clinical Trials Funding Opportunity Announcements

Applicant Information

Clinical Trials FOAs collage

NIMH has re-released several funding opportunity announcements (FOAs) addressing the clinical trials research that we support. Collectively, these opportunities define NIMH’s focus on an experimental medicine approach when supporting clinical trial research. This focus aims to accelerate treatment development and bring improved therapies to patients with mental disorders.

Please see our Frequently Asked Questions (FAQ) for more details.

NIMH Clinical Trial Funding Initiatives

Clinical Trial Pipeline - Phase of Intervention Development
First in HumanExploratory Experimental TherapeuticsConfirmatory EfficacyEffectiveness (Prevention, Treatment, Services)

First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01)*

 

Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34)

 

Exploratory Clinical Trials of Novel Interventions for Mental Disorders
(R61/R33)*

Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01)

Confirmatory Efficacy Trials of Non-Pharmacological Interventions (R01)

Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (Collaborative R01)

Exploratory Clinical Trials of Novel Interventions for Mental Disorders (R33)*

 

* The intent of the U01 and R21/R33 for drug development is to support early phase clinical trials to de-risk drugs, and industry can then support further development.

Scientific/Research Contact Information 
General Inquiries: NIMHClinicalTrials@mail.nih.gov
Application Due Dates: Standard Dates Apply

Scientific/Research Contact Information 
General Inquiries: NIMHClinicalTrials@mail.nih.gov
Application Due Dates: June 15, 2015 (R33 only); July 27, 2015 (R61/R33 only); October 14, 2015; February 17, 2016; June 15, 2016; October 14, 2016 for all application types (new, resubmission, and revision applications).

Scientific/Research Contact Information 
General Inquiries: NIMHClinicalTrials@mail.nih.gov
Application Due Dates: June 15, 2015; October 14, 2015; February 17, 2016; June 15, 2016;
October 14, 2016 for all application types (new, resubmission, and revision applications).

Scientific/Research Contact Information 
General Inquiries: NIMHClinicalTrials@mail.nih.gov
Application Due Dates: June 15, 2015; October 14, 2015; February 17, 2016; June 15, 2016;
October 14, 2016 for all application types (new, resubmission, and revision applications).

Scientific/Research Contact Information 
General Inquiries: NIMHClinicalTrials@mail.nih.gov
Application Due Dates: June 15, 2015; October 14, 2015; February 17, 2016; June 15, 2016;
October 14, 2016 for all application types (new, resubmission, and revision applications).

Additional Resources for Applicants

Selected Publications

Published Guide Notices

  • NOT-MH-15-012  (March 17, 2015) – Data Sharing Expectations for Clinical Research Funded by NIMH
  • NOT-MH-15-009  (January 16, 2015) – Notice Announcing Data Harmonization for NIMH Human Subjects Research via the PhenX Toolkit
  • NOT-MH-14-015  (June 12, 2014) - Data Sharing Expectations for NIMH-funded Clinical Trials
  • NOT-MH-14-007  (February 25, 2014) - NIMH Policy for Submission of Applications Containing Clinical Trials
  • NOT-MH-14-004  (January 15, 2014) - Enhancing the Reliability of NIMH-Supported Research through Rigorous Study Design and Reporting