Insel discusses challenges and new directions at NIMH

Within tight budget, NIMH updates its approaches to diagnosis and clinical trials.

The National Advisory Mental Health Council, which serves as the primary advisory body to the National Institute of Mental Health (NIMH), met on May 30 in Rockville, Md. In his report to the council, NIMH Director Thomas Insel discussed the “undoubling” of the National Institutes of Health (NIH) budget, which is slowly being eroded by both flat budgets that do not keep up with the biomedical inflation rate and the five percent cuts required of NIH under sequestration. NIMH itself is reducing currently funded extramural grants, intramural research and internal administrative staff each at a four percent rate.

Insel addressed some misunderstandings from one of his recent blog posts, which describes NIMH’s plans to develop a new framework for diagnosis of mental disorders that could ultimately replace the current DSM and ICD approaches. Insel clarified that today “the DSM and ICD-9 remain the diagnostic classification system for clinical care and reimbursement.” But he noted the limitations of the DSM and ICD approaches: that they are based on clinical signs and symptoms without regard to cause or treatment response. 

NIMH’s new approach, called the Research Domain Criteria (RDoC) project, examines specific forms of dysfunction at multiple levels of biological and behavioral analysis; these dysfunctions might be observed in various disorders as described in the DSM. According to Insel, NIMH aims to support studies that, instead of focusing on a particular disorder, examine dimensions across various disorders. Such research would eventually lead to a deconstruction of current disorder categories and a reconstruction of them more in line with “precision medicine.”

NIMH is also transforming the way it funds clinical trials, following the lead of the National Cancer Institute in the hopes of increasing the impact of its trials. According to Insel, NIMH wants to steer the scientific community away from efficacy trials for treatments, and towards an increased focus on understanding the specific targets of the treatments.

The number of clinical trials NIMH funds has decreased from 530 trials with $205 million in funding in 2008 to 264 trials with $111 million in funding in 2012. Most of the trials are funded by R01 grants that are examining the efficacy of psychosocial interventions, behavioral therapy, family therapy or counseling. NIMH is concerned that the portfolio lacks efficiency, transparency, sharing of common data elements and clinical impact. 

Insel emphasized that a trial’s success should be judged not only on whether it results in a published paper, but also on its impact on clinical practice. NIMH is calling for trials that teach the field about the underlying disorders, not just the treatment. Insel emphasized that negative findings are as informative as positive findings. New funding opportunity announcements for trials of this sort are expected to be issued later this summer.

For more information contact Karen Studwell.