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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). NIMH requires an experimental therapeutics approach to the development and testing of interventions, in which they serve not only as potential treatments, but as probes to generate information about the mechanisms underlying a disorder.  Studies proposed under these FOAs must clearly identify a target or mediator of the intervention being tested.  A positive result will require not only that an intervention ameliorate a symptom, but that it has a demonstrable effect on a target, such as a neural pathway or a key cognitive operation implicated in the disorder.

There have been changes with the current set of clinical trial FOAs. They still cover the development and testing of therapeutic and preventive interventions, covering a wide range of intervention modalities: cognitive, behavioral and other psychosocial approaches, psychopharmacological interventions, and interventions utilizing direct brain modulation/stimulation. But, the current set of FOAs attempts to better align the language in the FOAs with the concepts and language conventionally used with different intervention modalities. One major change in the current set of FOAs is that there are now two separate “early stage” FOAs for the development of 1) psychosocial interventions, and 2) drugs or direct brain modulation/stimulation devices.  However, there have been changes to all of the FOAs in an effort to clarify NIMH’s interest in an experimental therapeutics approach to the development and testing of interventions across all modalities. Applicants should carefully read the FOA to which they are responding and the Frequently Asked Questions.  Applicants are strongly encouraged to contact the Scientific/Research Contact listed at the end of the relevant FOA to discuss the FOA and NIMH priorities.

As notice (NOT-MH-14-007 ) indicates, NIMH will also prioritize funding for Career Development Award (K) and SBIR/STTR applications with a clinical trial focus that are consistent with the stated research goals and priorities relevant to clinical trials as outlined in the clinical trials 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)

 

Early Stage Testing of Pharmacologic or Device-based Interventions for the Treatment of Mental Disorders (R61/R33) and (R33)*

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

Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33) and (R33)

Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01)

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

* The intent of the U01 and R61/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: February 15, 2017; June 14, 2017; October 17, 2017; February 14, 2018; June 15, 2018; October 15, 2018 for all application types (new, resubmission, and revision applications).

Scientific/Research Contact Information 
General Inquiries: NIMHClinicalTrials@mail.nih.gov
Application Due Dates: February 15, 2017; June 14, 2017; October 17, 2017; February 14, 2018; June 15, 2018; October 15, 2018 for all application types (new, resubmission, and revision applications).

Scientific/Research Contact Information 
General Inquiries: NIMHClinicalTrials@mail.nih.gov
Application Due Dates: February 15, 2017; June 14, 2017; October 17, 2017; February 14, 2018; June 15, 2018; October 15, 2018 for all application types (new, resubmission, and revision applications).

Scientific/Research Contact Information 
General Inquiries: NIMHClinicalTrials@mail.nih.gov
Application Due Dates: February 15, 2017; June 14, 2017; October 17, 2017; February 14, 2018; June 15, 2018; October 15, 2018 for all application types (new, resubmission, and revision applications).

Scientific/Research Contact Information 
General Inquiries: NIMHClinicalTrials@mail.nih.gov
Application Due Dates: February 15, 2017; June 14, 2017; October 17, 2017; February 14, 2018; June 15, 2018; October 15, 2018 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