Addressing Methodological Challenges with Clinical Trials of Rapid-Acting Psychotropic Interventional Drugs (RAPIDs) (R01 Clinical Trial Required)

The National Institute of Mental Health (NIMH) is soliciting applications for research that addresses methodological challenges associated with clinical trials involving rapid-acting psychotropic interventional drugs (RAPIDs). RAPIDs have demonstrated promising benefits for the relief of depression, anxiety, and other mental health disorders. The goal of this notice of funding opportunity (NOFO) is to improve the understanding of the key components underlying the therapeutic effects of RAPIDs and thereby increase confidence in the results from clinical trials with RAPID intervention(s). • The research should focus on addressing methodological challenges associated with clinical trials involving RAPIDs. • Applicants should propose innovative trial designs and methods to improve the understanding of RAPIDs' therapeutic effects. • The NOFO will utilize the R01 activity code, and investigators with expertise in RAPID research and innovative trial design are encouraged to apply. • Collaborative research that integrates expertise in RAPID research and innovative trial design is also encouraged. • Applicants are encouraged to interact with the U.S. Food and Drug Administration (FDA) prior to application submission to ensure the proposed study will satisfy regulatory requirements.