Clinical Trials Funding Opportunity Announcements
NIMH has released several funding opportunity announcements (FOAs) addressing a new direction for 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 shift in focus aims to accelerate treatment development and bring improved therapies to patients with mental disorders.
NIMH Clinical Trial Funding Initiatives
|First in Human||Exploratory Experimental Therapeutics||Confirmatory Efficacy||Effectiveness (Prevention, Treatment, Services)|
|Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (Collaborative R01)|
* 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.
First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders
The purpose of this FOA is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanisms of action, investigational drugs, or drug candidates for the treatment of psychiatric disorders in areas of unmet medical need. The FOA also supports feasibility and pilot studies of novel devices. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, devices or combination treatments in order to attract private funding for further clinical development as Food and Drug Administration–approved treatments. A key aspect of this FOA is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development.
Exploratory Clinical Trials of Novel Interventions for Mental Disorders
These FOAs aim to support the efficient pilot testing of novel interventions for mental disorders in adults and children through an experimental therapeutics approach. Trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support “go/no-go” decisions about further development or testing of the intervention. These funding mechanisms are intended to speed the translation of emerging basic science findings of mechanisms and processes underlying mental disorders into novel interventions that can be efficiently tested for their promise in restoring function and reducing symptoms for those living with mental disorders.
Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders
The purpose of this Funding Opportunity Announcement (FOA) is to support confirmatory efficacy testing of non-pharmacological therapeutic and preventive interventions for mental disorders in adults and children through an experimental therapeutics approach. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support “go/no-go” decisions about further development or effectiveness testing of a targeted, scaled-up intervention. Intervention studies include, but are not limited to behavioral, cognitive, and interpersonal approaches, or a combination thereof. Interventions appropriate for efficacy testing must be based on a compelling scientific rationale, previous demonstration that the intervention engages and alters the hypothesized mechanism of action, a preliminary efficacy signal, and must address an unmet therapeutic need. Support will be provided for a trial of the intervention’s efficacy that includes measurement of the hypothesized mechanism of action and the relationship between change in the mechanism and change in functional or clinical effects. Ultimately, this FOA is intended to support a sufficiently- powered efficacy trial to determine the intervention’s potential for significant clinical benefit.
Pilot Effectiveness Studies and Services Research Grants
The purpose of this FOA is to encourage pilot research consistent with NIMH's priorities for: 1) effectiveness research on interventions with previously demonstrated efficacy, for use with broader target populations or for use in community practice settings, and 2) innovative services research directions that require preliminary testing or development.
- RFA-MH-15-330 (R34)
Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions
These FOAs aim to support investigator-initiated clinical trials to establish the effectiveness of interventions and to test hypotheses regarding moderators, mediators, and mechanisms of action of these interventions. These FOAs support clinical trials designed to test the therapeutic value of treatment and preventive interventions for which there is already evidence of efficacy, for use in community and practice settings.
Additional Resources for Applicants
Frequently Asked Questions
Read our Applicant FAQs.
NIMH Director's Blog
Hear thoughts from the NIMH Director, Dr. Tom Insel, on the rationale for moving to an experimental therapeutic approach to clinical trials in his blog.
- 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-14-015 (June 12, 2014) – Data Sharing Expectations for NIMH-funded Clinical Trials
- NOT-MH-14-001 (February 28, 2014) - Notice of Change to Funds Available for RFA-MH-15-300 "Exploratory Clinical Trials of Novel Interventions for Mental Disorders (R21/R33)"
- NOT-MH-14-007 (February 25, 2014) - NIMH Policy for Submission of Applications Containing Clinical Trials
- NOT-MH-14-008 (February 24, 2014) - Notice of Expiration of PAR-12-278 "Collaborative R01s for Clinical and Services Studies of Mental Disorders and AIDS (Collaborative R01)"
- NOT-MH-14-009 (February 24, 2014) - Notice to Discontinue Participation of NIMH in PAR-12-279 "Pilot Intervention and Services Grants (R34)"
- NOT-MH-14-004 (January 15, 2014) - Enhancing the Reliability of NIMH-Supported Research through Rigorous Study Design and Reporting
- NOT-MH-13-022 (September 12, 2013) - Notice of Intent to Publish a Funding Opportunity Announcement for Exploratory Clinical Trials of Novel Interventions for Mental Illnesses (R21/R33)