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Clinical Trials Funding Opportunity Announcements

Applicant Information

Clinical Trials FOAs collage

NIMH continues to support clinical trial applications through clinical trial-specific funding opportunity announcements (FOAs), which define NIMH’s focus on an experimental therapeutics approach. While the most recent NIMH Clinical Trial FOAs have recently expired, we anticipate publishing comparable FOAs for subsequent submission dates. Please continue to monitor the NIH Guide to Grants and Contracts  (you can subscribe  to receive weekly email notifications) or sign up to receive notifications from NIMH  and get updates on NIMH-issued or NIMH-co-sponsored FOAs.

For more detailed information, please visit NIMH Clinical Trials Funding Opportunity Announcements - Applicant FAQs.

NIMH Clinical Trial Funding Initiatives

Clinical Trial Pipeline - Phase of Intervention Development
First in Human Exploratory Experimental Therapeutics Confirmatory Efficacy Effectiveness (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

  • Gogtay N and Insel T. NIMH Clinical Trials: Portfolio, Progress to Date, and the Road Forward. National Institute of Mental Health. 2015.
  • Insel TR and Gogtay N. National Institute of Mental Health Clinical Trials: New Opportunities, New Expectations. JAMA Psychiatry . 2014 May 7. Epub ahead of print.
  • Gogtay N and Insel T. Changing NIMH Clinical Trials: Efficiency, Transparency, and Reporting. National Institute of Mental Health. 2014.

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