Psychology Issues and Debates

Underlying mental Illness

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.

NIMH Clinical Trial Funding Initiatives

* 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.

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.

Early Stage Testing of Pharmacologic or Device-based Interventions for the Treatment of Mental Disorders

The purpose of these FOAs is to support the early stage testing of pharmacologic interventions with novel mechanisms of action, or device-based interventions, for the treatment of symptoms or domains of altered functions in individuals with mental illness (e.g. schizophrenia, depression, autism, obsessive compulsive disorder, anxiety, bipolar disorder, etc.). These funding mechanisms are intended to support early stage testing of pharmacologic or device-based interventions using a protocol design where the presumed mechanism of action of the intervention is adequately tested, to provide meaningful information where target modulation yields a dose-dependent neurophysiological/clinical/behavioral effect.

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).