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NAMHC Minutes of the 220th Meeting

February 12-13, 2009

Department of Health and Human Services
Public Health Service
National Institutes of Health
National Institute of Mental Health
 

Introduction

The National Advisory Mental Health Council (NAMHC) convened its 220th meeting in closed session to review grant applications at 11:00 a.m. on February 12, 2009, at the Neuroscience Center in Rockville, Maryland, and adjourned at approximately 5 p.m. (see Appendix A: Review of Applications). The NAMHC reconvened for an open session on the following day, February 13, 2009, in Building 31C, National Institutes of Health, from 8:30 a.m. until adjournment at 12:30 p.m. In accordance with Public Law 92-463, the open policy session was open to the public. Thomas R. Insel, M.D., Director, National Institute of Mental Health (NIMH) chaired the meeting.

Council Members Present at the Grant Review and/or Open Policy Sessions
(See Appendix B: Council Roster)

Chairperson: Thomas R. Insel, M.D.

Executive Secretary: Jane A. Steinberg, Ph.D.

Council Members:
David G. Amaral, Ph.D.
Carl C. Bell, M.D.
Glorisa J. Canino, Ph.D.
Elizabeth Childs, M.D., M.P.A.
Robert Desimone, Ph.D.
Ralph J. DiClemente, Ph.D.
Howard B. Eichenbaum, Ph.D.
Daniel H. Geschwind, M.D., Ph.D.
Portia E. lversen
Dilip V. Jeste, M.D.
Pat R. Levitt, Ph.D.
David A. Lewis, M.D.
John S. March, M.D., M.P.H.
Steven M. Paul, M.D.
Enola K. Proctor, Ph.D.

Ex-Officio Members:
Ira Katz, M.D., Ph.D., Department of Veteran Affairs
John A. Ralph, Ph.D., Department of Defense

Ad Hoc Member:
Thomas H. McGlashan, M.D., Yale

Liaison Representative Present at the Open Policy Session:
Anna Marsh, Ph.D., representing A. Kathryn Power, M.Ed., Center for Mental Health Services, (CMHS), Substance Abuse and Mental Health Services Administration (SAMHSA)

Others Present:
Virginia Anthony, American Academy of Child & Adolescent Psychiatry
Stephanie Bernstein, Institute for the Advancement of Social Work Research
Bruce Cuthbert, University of Minnesota
Debra Derr, Transcriptionist, Executive Reporters
Blair Feldman, Council on Social Work Education
Reuven Ferziger, Ortho-McNeil Janssen Scientific Affairs
Mark Homonoff, Beth Israel Medical Center, NY
Sarah Hutcheon, The Society for Research in Child Development
Meghan McGowan, Federation of Behavioral, Psychological & Cognitive Sciences
Ann Michaels, National Foundation on Mental Health
Diana Morales, Mental Health America
Eve Moscicki, American Psychiatric Institute for Research and Education
Wendy Naus, Lewis-Burke Associates LLC
Emily Norton, Research! America
Jim Payne
Amy Pollick, Association for Psychological Science
Stephanie Reed, American Association for Geriatric Psychiatry
Darrel Regier, American Psychological Association
Beth Roy, Social and Scientific Systems, Inc
Bette Runck, Science Writer
Andrew Sperling, National Alliance on Mental Illness
Clare Stroud, Institute Of Medicine
Karen Studwell, American Psychological Association
Jill Wetzel, Infinity Conference Group

Open Policy Session: Call to Order and Opening Remarks

NIMH Director Thomas R. Insel, M.D. called the open policy session to order, welcoming all in attendance. He introduced five new Council members:

  • David Amaral, Ph.D., Professor in the Department of Psychiatry and Behavioral Sciences at the University of California, Davis.
  • Ralph DiClemente, Ph.D., Candler Professor in the Rollins School of Public Health and the Associate Director of Prevention Science in the Emory University Center for AIDS Research.
  • Howard Eichenbaum, Ph.D., Professor and Chairman, Department of Psychology, Director of the Center for Memory and Brain, and Director of the Cognitive Neurobiology Laboratory at Boston University School of Medicine.
  • Portia Iversen, a co-founder of Cure Autism Now Foundation.
  • Steven Paul, M.D., Executive Vice President for Science and Technology at Eli Lilly and President of Lilly Research Laboratories, a division of Eli Lilly and Company. He is also Professor of Pharmacology and Psychiatry at Indiana University School of Medicine.

Dr. Insel also introduced Thomas McGlashan, M.D., an ad hoc member to our Council and Professor in the Department of Psychiatry at Yale University School of Medicine and John Ralph, Ph.D., our Council representative from the Department of Defense. Dr. Ralph is an active duty naval commander and clinical psychologist who is currently stationed at the National Naval Medical Center in Bethesda, where he heads the Mental Health Department and manages all psychiatrists, psychologists, social workers, and support personnel.

Approval of the Minutes of the Previous Council Meeting

Turning to the minutes of the September 2008 Council session, Dr. Insel asked if Council members had revisions or comments on the minutes. Hearing none, the minutes were unanimously approved.

NIMH Director's Report

NIH Update
Peer Review Update
Enhancements to the NIH peer review system are now underway. NIH has been setting the stage for these changes with staff and the broader scientific research community through communications such as policy notices in the NIH Guide for Grants and Contracts, briefings to NIH Councils, training for NIH staff, press releases, newsletter articles, and Listserv communications. In addition to providing these resources, the Enhancing Peer Review Web site  is regularly updated, and a dedicated e-mail box for questions from the public has been created. Scientific Review Officers have been communicating with reviewers and preparing them for the training they will receive as the spring and summer review meetings commence.

Research, Condition, and Disease Categorization (RCDC)
In January 2009, NIH added the new Research, Condition, and Disease Categorization (RCDC) reports to the Research Portfolio Online Reporting Tool (RePORT) Web site . RCDC is a computerized process that NIH uses at the end of each fiscal year (FY) to sort and report the amount it funded in each of 215 historically reported categories of disease, condition, or research area. RCDC provides consistent and transparent information to the public about NIH-funded research. For the first time, a complete list of all NIH-funded projects related to each category is available. By clicking on each of the categories, the public can access full project listings for that category and view, print, or download the detailed report.
Some funding amounts that RCDC reports might differ from NIH reports issued in the past, due to a new sorting method used by RCDC. However, the way NIH budgets and spends tax dollars throughout the year remains the same.

Budget
With regard to the NIH budget, NIH is still operating under the FY 2009 continuing resolution. The final budget is expected to include a 2.2 to 2.4 percent increase over the 2008 budget. In addition we anticipate a stimulus package to include approximately $10 billion for NIH and require that the funds be obligated in FYs 2009 and 2010. This suggests that the Congress sees the NIH budget as an important way to stimulate the economy. How NIH will invest these funds will be decided over the next few weeks.

NIMH Update
The Strategic Plan, which became public before the last Council meeting, has moved into the implementation phase. Its four objectives, in brief, pertain to pathophysiology; trajectories of illness; new and better interventions; and the public health impact of NIMH-supported research. Extramural and intramural staff are currently engaged in efforts to identify outputs and outcomes for each objective described in the Strategic Plan. The Institute is involved in sharing the Strategic Plan with grantees, reviewers, and the public; setting priorities for funding; shaping the Requests for Applications (RFAs) issued; and, increasing accountability.

Dr. Insel highlighted one such implementation item: developing, for research purposes, new ways of classifying mental disorders based on dimensions of observable behavior and neurobiological measures. As discussed in the Plan, the diagnosis of mental disorders is currently based on clinical observation. However, the way that mental disorders are defined in the present diagnostic system does not incorporate current information from integrative neuroscience research, and thus is not optimal for making scientific gains through neuroscience approaches. Researchers are in need of a classification system based upon and suitable for research, involving criteria that place as much emphasis on validity as on reliability, are more dimensional than categorical, and that account for the continuing problem of co-morbidity. A project to develop such criteria as these is in an early stage. Bruce Cuthbert, Ph.D., Professor of Psychology at the University of Minnesota will be joining NIMH to head an effort focusing on this novel system for defining disorders. Dr. Cuthbert will interact with ongoing efforts to revise the DSM and International Classification of Diseases (ICD), both of which are scheduled for publication in 2012.

Dr. Insel reported a change to the Institute’s five standing review committees. As the numbers of applications reviewed in the NIMH Chartered Review Committees have been lower than anticipated, the two review committees that focus on adult interventions (Interventions Committee for Adult Mood and Anxiety Disorders (ITMA) and Interventions Committee for Disorders Related to Schizophrenia, Late Life or Personality (ITSP)) will be combined into one review committee called the Interventions Committee for Adult Disorders (ITVA). This committee will review applications concerned with clinical trials of pharmacotherapeutic, psychotherapeutic, and combination treatments as applied to mood and anxiety disorders, schizophrenia spectrum disorders, personality disorders, disorders of late life, and related mental health problems in study populations 18 years and older.

Dr. Insel noted that the NIH Revitalization Act of 1993 requires each Advisory Council to review its Institute’s compliance with NIH guidelines on the inclusion of women and minorities in clinical research. Dr. Insel called the Council’s attention to the NIMH Biennial Report regarding the inclusion of women and minorities in clinical research. The Report details the numbers of participants in NIMH research studies. Dr. Insel noted that the overall data of the report may be somewhat skewed by two large studies (a web-based study and a study involving U.S. Air Force recruits) enrolling close to 4 million persons in total. The web-based study had a very high rate of unknown/not reported data for both gender and ethnic or minority group status and the USAF recruit study was an 80% male population. Dr. Insel suggested that the data presented in this report detailing the participants in phase III clinical research may be a more accurate representation of who the NIMH is studying. The Council approved the report.

Discussion
With the NIMH Strategic Plan as a focus for NIMH-funding decisions, Dr. Proctor asked for information on what has been funded within each of the four objectives of the Plan. Dr. Insel said that the internal working groups are doing an initial scan of current investments, and this will serve as a baseline. RCDC will also make it possible to track the investments for the categories that are in the congressional mandate.

Dr. Bell noted that the new Institute of Medicine (IOM) report on prevention calls for much more research on implementation and dissemination research. He said he expects President Obama to emphasize prevention. Dr. Insel noted that such an emphasis would be consistent with the Strategic Plan.

Dr. Jeste asked how the Council can help NIMH distribute the stimulus funds quickly and judiciously. Dr. Insel said that Council feedback on the concept clearances to be reviewed today will aid in implementing some of the work under consideration. In addition, there may be omnibus RFAs that will come from NIH as well. It may, however, be necessary to consult with the Council electronically in the coming months and over the summer.

Dr. March noted that NIMH’s 20 years of very good intervention research had not influenced clinical practice very much. Those who were doing intervention research continue to do the kinds of studies that have not affected practice, and they resist new models for doing clinical trials. Dr. March suggested that a Council workgroup on interventions be formed to explore how to implement the Strategic Plan. Dr. Proctor followed-up on Dr. March’s idea and suggested that a Council workgroup might consider how to ensure that NIMH’s investment in clinical and intervention research gets implemented in settings where the public can benefit. Dr. Insel noted that implementation was the focus of the "Road Ahead" report done 2 years ago, but noted that he understood Dr. March’s suggestion as aimed at developing the next generation of interventions to implement.

Dr. March pointed out that there are many interventions that work, although not optimally, but they are not widely practiced clinically. He recognized that to the extent that time-consuming trials are done with small samples in academic health centers and at high cost, it is not surprising that such interventions are not implemented in everyday practice. A different type of trial and infrastructure is needed to optimize treatments, to look for next-step treatments, to explore moderator variables that will make it possible to segment the data into personalized medicine, or to look for biosignatures or biomarkers for treatments. Dr. Insel said that if new money is available for comparative effectiveness trials, it may be necessary to come up with new models for the next generation of trials.

Dr. Paul suggested that NIMH form partnerships with private sector foundations that are very interested in the use of all types of intervention. Such foundations have a vested interest because effective treatment reduces morbidity and mortality, and it reduces the impact on other parts of the health care system. Dr. Insel asked Council members if they endorse the idea of a workgroup on interventions and received full support of Council.

NIMH Council Workgroup on Neurodevelopment: Update on Follow-Up Activities

Molly Oliveri, Ph.D., Director of the Division of Developmental Translational Research (DDTR) briefly reviewed the genesis and course of the neurodevelopment workgroup. She acknowledged the contributions of the workgroup members and noted that all NIMH divisions, including the Division of Intramural Research Programs (DIRP), are involved in implementing the workgroup’s recommendations.

The workgroup’s primary research priorities outlined in the report were aimed at stimulating integrative research, cross-level research, and translational science–all in the service of understanding neurodevelopment of mental disorders, as well as tackling training and infrastructure needs. (The workgroup’s full report is available on the web - PDF file, 27 pages.)

In an effort to implement the recommendations of the workgroup, an 18-member cross-divisional extramural neurodevelopment team chaired by David Panchision, Ph.D. and Julia Zehr, Ph.D. was formed. This collaborative group is developing national symposium submissions and initiatives, and its members have consulted on grant applications. The DIRP is working to establish a basic neurodevelopment research program, as explicitly recommended by the workgroup. Extramural and intramural scientists will meet shortly to shape the areas of most importance for recruitment. Another activity in mobilizing NIMH staff scientific efforts is a restructuring of DDTR that refocuses the division’s mission to translating knowledge from basic science in order to discover the developmental origins of mental disorders and effect their prevention and cure. The three components of this mission are neurobehavioral mechanisms, developmental trajectories, and innovative interventions.

In September 2008, NIMH sponsored a meeting for recipients of pre- and post-doctoral fellowships and diversity supplements to provide junior investigators with tools necessary to continue along the path of competitive research support and transition to independence. A meeting of institutional training grant directors from the Division of Neuroscience and Basic Behavioral Science (DNBBS) and DDTR will be held in March 2009 to discuss the Council’s recent training report; as in the other meeting, breakout groups will hear of divisional developmental translational priorities and the neurodevelopment report recommendations.

In addition, NIMH extramural staff is working to mobilize extramural researchers through participation in several scientific meetings and NIMH-supported workshops. These include the Neuroimmunology, Brain Development, and Mental Disorders workshop; a symposium at the Winter Conference on Brain Research focusing on highlights of recent neuroimaging findings suggesting how the brain networks that support different cognitive functions develop; an upcoming meeting on the diagnosis and classification of bipolar disorder in children and adolescents that will attempt to develop a unified approach to assessment; an upcoming conference on Comparative and Primate Research that will focus on improving cross-species comparability; and a meeting planned for September 2009 that will discuss the neurophysiological basis of electrophysiological methods (EEG, ERP, MEG) and explore the potential of electrophysiological signals as important endophenotypes or biomarkers to predict illness onset or response to treatment.

The recommendations of the neurodevelopment workgroup have been influential in recent NIMH initiatives and funding efforts. These initiatives include a funding announcement for NIMH administrative supplements to extend neurobiological and behavioral methods, approaches, and findings to studies in late postnatal development (NOT-MH-08-009). These are 1-year administrative supplements to NIMH-funded projects to extend currently supported basic neuroscience research from adult mammalian model systems into late postnatal developmental periods. In a similar effort, DDTR awarded an administrative supplement to add longitudinal neuroimaging to an ongoing prospective developmental study of affective disorders in early childhood.

The funding announcement for the consolidated Silvio O. Conte centers for basic and translational mental health research (PAR-08-194) includes a specific focus on neurobehavioral developmental mechanisms. In keeping with the workgroup recommendation that research and training activities be brought together, applicants have the option of including a companion training program with their center application. Another NIMH initiative titled “Novel Interventions for Neurodevelopmental Disorders” (RFA-MH-09-020/021) has a focus on fostering the development of novel interventions (pharmacologic, physiologic, cognitive, psychosocial, psychoeducational, behavioral and/or combinations) to improve functioning in domains commonly affected by neurodevelopmental disorders.

“Comparative interdisciplinary studies of cerebral cortical development” (RFA-MH-09-080) is an NIMH initiative with a focus on exploratory studies crossing levels of analysis, species, and postnatal developmental periods. The goal is to define the neurodevelopmental basis of complex behaviors related to mood, cognition, and social function. The “Biobehavioral Research Awards for Innovative New Scientists (BRAINS)” (RFA-MH-09-100) program is an initiative for principal investigators in the early stage of their careers to jumpstart an innovative clinical, translational, or basic research program. The program will have a new theme each year; the first theme is neurodevelopment for the FY 2009 awards.

Initiatives planned for the near future include a new RFA on exploratory studies of induced pluripotent stem (iPS) cells from healthy and mentally ill populations (RFA-MH-09-130). The initiative will support a proof-of-concept and rapid-development project with the goal of generating and characterizing iPS cells from human subjects with cognitive, affective, social, sleep, and developmental brain disorders. NIMH also plans to re-issue an RFA on novel interventions for neurodevelopmental disorders to enable additional awards in FY 2009.

In addition to the NIMH-specific programs described, NIH has several ongoing parallel activities. These include the NIH Blueprint, which is a collection of 15 Institutes and Centers with a strong commitment to neuroscience research. The Blueprint’s NIH Toolbox, which is under development and validation, will provide standard behavioral assessment tools across a range of domains to facilitate rapid comparability and advancement of research. In September 2008, the NIH Blueprint awarded a contract to the Allen Institute to develop a gene expression atlas for rhesus macaques that crosses four developmental time points and five brain regions. It is intended to provide a bridge from existing atlases in other species to future efforts in humans. As with other activities, the atlas will be available to the public. In addition, both the NIMH Strategic Plan and the strategic plan for autism spectrum disorder research finalized by the Interagency Autism Coordinating Committee recommend many opportunities and objectives in the neurodevelopmental area.

Drs. Levitt and March, co-chairs of the Council workgroup, commended the NIMH staff for their remarkable responsiveness to the workgroup recommendations. Dr. March said that the group wanted to do three things: switch the focus from cross-sectional studies to trajectories of development; move across levels of analysis from cells to systems to people and do it across species points and across platforms (mice, monkeys and humans); and encourage interdisciplinary collaboration. All of the initiatives and programs described by Dr. Oliveri together, and many individually, meet those goals.

Dr. Lewis agreed and asked how long the emphasis on neurodevelopment would continue. Dr. Insel said there is no time frame as yet. The separate initiatives are on different schedules. The BRAINS initiative, which is new, is similar to the Pioneer Award, but is for early-stage investigators. Neurodevelopment is the topic for the first year. Its future will depend on experience with the program. Most RFAs are 4 or 5-year efforts. Thus, for the next few years, neurodevelopment will be a substantial part of the Institute’s focus.

Global Health and Science Agenda

Dr. Insel introduced Craig Van Dyke, M.D., former Chair of Psychiatry at the University of California, San Francisco (UCSF), who is serving in the NIMH Director’s Office focusing on the Institute’s role in global mental health. Dr. Van Dyke opened his talk by mentioning several international mental health efforts: significant investment in neuroscience and mental health research in Singapore, China, India, Brazil, South Africa; major World Health Organization (WHO) mental health initiatives, particularly in closing the treatment gap for mental illness; the possibility that health diplomacy is becoming a major element in U.S. foreign policy; and, greater involvement in global mental health issues by foundations and non-governmental organizations.

Health Diplomacy
The President’s Emergency Plan for AIDS Relief (PEPFAR) was created in 2003, in response to the U.S. government’s recognition that AIDS is not only a health problem, but also a security issue, since the disease has the possibility of destabilizing governments in countries with very high prevalence. With a 5-year budget of $15 billion, PEPFAR has started antiretroviral treatment for almost two million people. The funding is expected to increase, and the program is likely to begin treating co-morbid medical and psychiatric conditions and drug abuse problems, as well as HIV-AIDS.

The impact of chronic, non-communicable diseases was addressed in two recent reports, one from the IOM, the other from the Central Intelligence Agency. The IOM report recommended that by 2012, $15 billion a year be committed to a portfolio in health diplomacy that is less weighted toward communicable diseases. It also emphasized the need for health services research. A similar report was issued by the National Intelligence Council, which points out the security implications in destabilizing governments that are unable to provide adequate care for their citizens with chronic non-communicable diseases, including mental disorders.

Burden of Disease
Depression is one of the top causes of disability in the world, particularly for people aged 15 to 44. At any given moment, nearly 100 million people in the world are suffering from depression, and many of them receive little or no treatment. Last year, the WHO launched a major initiative, the mh-GAP Program, in an effort to close the treatment gap and to scale up resources to deliver evidence-based mental health care worldwide. Efforts to reduce the burden of disease focus on delivering services in primary care settings. The experience of developing countries that have few mental health professionals has relevance for this country, since up to 77 million Americans live in areas that are similarly lacking in mental health resources.

Rationale for International NIMH Research
Dr. Van Dyke noted that science is the only global culture; good biomedical research, wherever it is conducted, helps people everywhere. It is in America's best interest to maximize the worldwide investment in neuroscience and mental health research by building capacity in other countries to create a research workforce. Those countries could develop their own research institutes and collaborate with U.S. efforts. India and China, in particular, are now well positioned to fund their components of a study, and they could conduct many studies at a fraction of the cost of a U.S. study.

NIMH has a long history of commitment to international research. Its current involvement in 40 countries represents 2 percent of extramural funding, 80 percent of which is a foreign component of a U.S. grant. Those proportions are consistent with the history of NIH at large. In addition, the NIMH has been involved in global efforts in HIV-AIDS, and that experience can inform a broader emphasis on mental health care.

Research Opportunities in Global Mental Health
With the significant amount of interest from the next generation of researchers, Dr. Van Dyke outlined several lines of international research that warrant support, such as:

  • Novel approaches to care;
  • Clinical trials: countries with very stable populations offer the opportunity to do clinical trials of medications and other treatments with very high retention rates. They can frequently be done at a fraction of the cost of a U.S. study;
  • The integration of primary care and mental health care. This is what the WHO program is focused on. Many countries and parts of the U.S. have so few mental health professionals that they need innovative models to deliver mental health services in primary care settings;
  • Access to longitudinal datasets;
  • Population genetics;
  • Large epidemiologic studies focused on unique stressors, such as famine or toxins, and also on ways to identify the protective effects of support systems;
  • Basic science: research on cell lines, tissue repositories, experimental animal models, and probe libraries.

Another issue is training. Medical students and those in related fields are expressing tremendous interest in global health, including global mental health. NIMH might consider its overall training strategy in global mental health for US institutions, particularly as it relates to areas of strategic importance. In addition, NIMH might consider building capacity in other countries by assisting in the training of their scientific workforce. Both training efforts could be addressed in collaboration with the Fogarty International Center.

Dr. Insel opened the discussion period by emphasizing that NIMH is interested in Council members’ advice on revising NIMH international programs. Dr. Jeste indicated his support for global mental health and emphasized three areas of research: cross-cultural differences in biomarkers; studies of prevention strategies in different parts of the world; and, innovative studies to separate environmental from biological contributions to neurodevelopment and aging in populations.

Dr. March endorsed greater involvement in global health. He said that he was particularly interested in building research capacity in low-income countries. Dr. Van Dyke agreed with training scientists who return to their countries to continue as collaborators in research strategies learned in this country. Dr. Insel said that NIMH has joined the Fogarty Scholar's Program, which brings scientists to the NIH for a few weeks in the summer and sends U.S. scholars to the other countries, building an ongoing relationship. Because of widespread interest, mental health researchers are now participating in the program.

Dr. Bell said that his NIMH-supported HIV-prevention research in South Africa provided an opportunity for many South Africans to receive training in methodology, statistics, and other technology. It is much less expensive to do drug research, psychosocial intervention, and prevention research in developing countries. He noted that the soon-to-be-released IOM report would show that the United States lags far behind other countries in prevention but might consider partnering with some countries at the forefront such as Australia, Norway, Sweden, and Finland.

Addressing Disparities in Mental Health Care

Philip Wang, M.D., Dr. P.H., Director of the Division of Services and Intervention Research enumerated five caveats that should be kept in mind when reviewing the data on disparities in mental health care:

  • On occasion, differences in care might be clinically appropriate
  • Some differences in care might be caused by the needs of populations
  • Disparities exist across the globe and are not just a problem for the United States, as shown by the WHO World Mental Health Survey initiative
  • Disparities exist across health care and are not just an affliction of mental health care
  • Disparities exist across other demographic groups and are not true only for racial and ethnic minorities.

Dr. Wang and his colleagues have shown that in the general population, fewer than half of those with an active mental disorder received any form of care within the prior year. The situation is even worse among racial and ethnic minorities, who in some cases are half again as likely to get care. Among those who do manage to access any form of care, racial and ethnic minorities are less likely to get their care in the health care system.

Treatment often stops prematurely among racial and ethnic minorities. In both the United States and Canada, black patients were more likely than white patients to drop out of treatment prematurely. Racial and ethnic minorities are also underserved because clinicians tend to be slower to adopt new practices in treating them. Data from the American Psychiatric Association's Practice Research Network, which is a nationally generalizable sample of psychiatrists, show that clinicians were significantly less likely to adopt new atypical antipsychotic medications for non-white patients with schizophrenia spectrum disorders than for white patients.

Another way in which racial or ethnic minority patients are underserved is that they can receive too little or too much of treatment regimens. For example, a 2005 study of the elderly in a pharmacy benefit program in Pennsylvania found that non-white depressed patients were more likely than white patients to receive sub-optimal antidepressant regimens, particularly potentially low-intensity regimens, including doses beneath the ranges recommended in prescribing guidelines, durations that are too short to be effective, and fewer than recommended monitoring visits.

Overall quality and likely effectiveness of the treatment for minorities with mental disorders are often sub-optimal. Only about a third of all patients with depression, generalized anxiety disorder, and panic disorder receive guideline-concordant treatment, but minority patients who manage to access the general medical sector are even less likely to receive guideline-concordant care. African Americans are only one-tenth as likely. Among patients who manage to access the mental health specialties, African Americans are again only one-tenth as likely to get care that can meet some basic standard of quality.

Given these findings, NIMH is heavily invested in developing interventions to enhance the availability of care, its quality, and its outcomes in a variety of settings, particularly in primary care. Such an investment appears to yield positive results. At least one very large study of collaborative care, Partners in Care, showed that the quality of depression care improved for African Americans, Latinos, and white patients. However, clinical outcomes improved significantly only among the Latinos and African Americans. Meanwhile, health care costs associated with intervening through care management were substantially lower for the Latino patients than the non-Latino white patients. In summary, active interventions directed to minority populations appear not only to improve effectiveness but also may be more cost effective than interventions directed at the majority population.

Dr. Levitt asked if disparities would be examined in patients with developmental disabilities. Although the economic burden on states for that population is smaller overall than for other groups because the population is smaller, costs per individual are much higher. This group typically gets overlooked in discussions of disparities in health care. Data now indicate, for example, that almost 50 percent of adults with autism are taking a psychotropic medication.

Dr. Bell noted that people of color are still not adequately represented in clinical trials. He noted that studies of suicide could benefit from research into why black women have historically low rates of suicide. The only way to lessen disparities is through prevention, he said.

Dr. Jeste suggested that it is important to examine differences not only in health care delivery across groups but also within ethnic groups. Among Latinos, for example, there are significant differences between monolingual Spanish-speaking and bilingual, bicultural Latinos; bilingual, bicultural Latinos are more like Caucasians. Acculturation makes a significant difference. Dr. Canino endorsed the need for subgroup analysis. She also pointed out that most of the disparity research has been done with adults, very little with children. She said that improvement and enhancement treatment programs are needed that are geared toward families and children.

The Emerging Genetics of Psychotic Illnesses: A Revolution in Psychiatry

Edward Scolnick, M.D., Senior Associate Member at the Broad Institute of Massachusetts Institute of Technology and Harvard and Director of the Psychiatric Disease Program opened his presentation with a review of the initial evidence showing that genetic inheritance is the largest single risk factor for schizophrenia and bipolar disorder. Data from family studies demonstrate that the relative risk for a first-degree relative of an ill individual is substantially higher than it is for the general population. Twin studies confirmed the risk: concordance rates for monozygotic twins are several times greater than for dizygotic twins, who have no greater genetic relationship than siblings born of independent pregnancies. The concordance rate for schizophrenia in monozygotic twins is greater than 40 percent and that for bipolar disorder is almost 60 percent. Those rates are comparable to those found in other diseases with complex genetics, such as type-II diabetes.

Of the two unambiguous associations that have been found in bipolar disorder, one has been replicated by several different groups: Ankyrin G, a gene that elevates the risk of the disorder, coordinates the various complexes in membrane sites, and it is especially important for sodium and potassium channels. This specificity is of interest because lamotrigine, a medication used to treat bipolar disorder, is thought to block sodium channels. Dr. Scolnick said that he and his colleagues are trying to determine the exact molecular defect in Ankyrin G that confers risk, and recent findings suggest that channel dysfunction is involved in the pathophysiology of bipolar disorder.

The first association studies of schizophrenia found a protective association in the region on chromosome 6 containing the major histocompatibility locus. This is a very complex region that contains many genes and still needs to be explored. Another association is to the Myo18B gene, which seems to be statistically significant. To date, these studies are based on relatively small sample sizes, and additional samples are being collected. As the sample sizes grow to 20,000 or 30,000 for each disease, many more genes will be associated unambiguously.

An additional discovery in schizophrenia is the greater burden of genome-wide rare copy-number variations (CNVs) in patients than in unaffected individuals; the increase is small, but unambiguous. Compared with unaffected individuals, patients with schizophrenia have more genes intersected by CNVs and more single-occurrence CNVs. Further, CNVs that disrupt genes are more common in patients, and there are more large deletions (more than 500 kilobases). These findings have been reproduced by several groups, and they are among the first reproducible genetic findings in schizophrenia. The International Schizophrenia Consortium, under the leadership of Pamela Sklar, M.D., found three different large deletions, one previously known on 22q11.2, another on 15q15.3, and one on 1q21.1. The work has been reproduced by the Icelandic group, which detected one new deletion. Over the last year, it has been observed that these large deletions have different phenotypic expressions. Phenotypes include mental retardation, autism, learning disabilities, epilepsy, and schizophrenia.

What accounts for the association of these different phenotypes with the same large 500-kilobase deletions? One possibility is that either a prenatal or postnatal environmental influence produces an effect when a gene has been deleted. Only one of the two copies of the normal gene is deleted, which raises a second possibility: the copy of the normal gene that has not been deleted affects the functions of the proteins made by the intact strand and thus accounts for the varying phenotypes. A third possibility is that other variations in many other genes in the genome of the affected individuals account for the different phenotype in the presence of a large deletion. Summarizing this line of inquiry, Dr. Scolnick said that specific deletions account for about one percent of cases of schizophrenia. The effects are large, but they're not fully penetrant, that is, not truly Mendelian. In some cases, the genetic change has been found in an apparently normal parent; in other cases, it is found de novo. These findings have led to the speculation that all cases of schizophrenia must arise from rare, highly penetrant variants.

Dr. Scolnick said, however, that in addition to rare changes that have a high degree of penetrance, there are also common variants that play a major role in schizophrenia and bipolar disorder. The genetic complexity of these diseases is no different than the genetic complexity of cancer, in which gene rearrangements, deletions, mutations, and amplifications have been found. Whether common variants play a major role in the risk for schizophrenia and bipolar disorder is an open question that can be studied empirically. Until the methods for doing large-scale human genetics on complex diseases were developed in the last 3 or 4 years, it was impossible to examine the human genetics of these diseases at a molecular level.

Many clinical questions will be possible when genetic data are refined. Can you come up with a score that will be diagnostic of risk for schizophrenia or bipolar disorder? Can you identify in a blinded study a group of patients who are at risk for getting the disease based on the polygene score? Will it be possible to create clear quantitative criteria for entering people in long-term prevention and early intervention studies? The genetic data will need to be related to natural history, drug response, and other diagnostic factors. In addition, Dr. Scolnick suggested that new DSM categories could incorporate genetic findings instead of being purely descriptive.

The implications for treatment, Dr. Scolnick said, are that developing new treatments from the genetic findings would entail understanding the biochemical pathways by which treatment mechanisms disrupt disease pathophysiology. Lithium, for example, works at one part of a protein hormone signaling pathway stimulated by the hormone Wnt. Emerging hypotheses for the first time have started to impose genetic findings with biochemical findings in a metabolic pathway that actually may be involved in the pathogenesis of schizophrenia, and perhaps bipolar disorder. Over time, this work will clearly lead to ideas about new treatments and new approaches to treatment.

To get even more detailed information, Dr. Scolnick and his colleagues are using DNA strategies to sequence the intact strands from the gene-deletion regions and the exons from the top 400 or 1000 genes from the whole genome scans. Those sequencing approaches will allow them to define less common variants that can be used for more detailed mapping studies. The initial mapping studies use common variants that are present in greater than 5 percent of the population. Sequencing the top genes will identify polymorphisms that are present in 1 percent of the population. That will allow even more detailed mapping, the discovery of additional genes involved in risk and allow further refining and amplifying of the pathways. The ongoing work takes advantage of new machines that do DNA sequencing and technical methods that are being developed.

Applying the new knowledge to treatment will follow a model used for Fragile X syndrome, a Mendelian disease the root cause of which is strongly associated with some cases of autism. After the gene was discovered, the underlying pathophysiology became much clearer. Animal models have been created with the human defect, an accomplishment that has eluded the study of schizophrenia and bipolar disorder. As the research continues, the abnormal physiology is clarified, which leads to the discovery of new treatments. When results of the treatment prove beneficial in animals, it is developed for humans. The sequence is as follows: identify the genes, understand the functional consequences, do various cell-based assays, devise mouse models with a quantifiable phenotype, conduct chemical screening, do human trials, and make available to the broader population.

Other approaches for studying genetic function have also been developed, such as the study of the disc gene in the zebrafish and reprogramming skin cells to neurons with known genetic backgrounds.

The international collaboration for studying the genetic architecture of schizophrenia, bipolar disorder, and autism, which was begun by the Broad Institute, is now being extended to stimulating creative ideas for new drug discovery. Independent of the Broad Institute’s effort in psychiatry, it has put in place a state-of-the-art high-throughput screening facility that was originally started by Stuart Schreiber, Ph.D. Compound collections are being developed at the Broad with a novel set of compounds, and the group has access to a compound collection from the NIH Roadmap program. The Broad Institute is welcoming anyone with an idea for a screen or a pathway that can lead to a new way of treating severe mental illness. It will help in the development of the assay and follow-up medicinal chemistry, and it will require that the results be published eventually in the public domain. The 3-year pilot program will probably run 10 screens a year for outside groups if it gets enough applications.

Dr. Scolnick closed by stating that unraveling the causes of severe mental illness is now possible if sufficient funds and samples are available. With the new technologies, the field can be transformed from one of empiricism and description to a quantitative science that can lead to improvements in the diagnosis and treatment of patients who suffer from these illnesses.

In response to a question from Dr. Paul, Dr. Scolnick agreed that the polygene score does not identify disease-susceptibility genes themselves, but rather is a marker for those genes, which are located, potentially, in particular regions. Dr. Paul asked if the risk that is identified approaches what is found in first-degree relatives with these various alleles. Dr. Scolnick said that the polygene score accounts for approximately 40 percent of the familial risk of the disease, a degree of risk that Dr. Paul found impressive. Dr. Scolnick said it is similar to the probability of predicting height, which involves hundreds of genes.

Dr. Lewis noted that one of the challenges of the NIH initiative for compound screening is that it requires that an optical assay has been developed that can be converted into a high-throughput system. Moving from the target to an appropriate assay has been difficult for many in the field. He asked if the Broad’s new initiative is going to make assay development expertise broadly available. Dr. Scolnick said that it will. The program can screen against individual biochemical targets and cell assays.

Dr. Desimone said that Dr. Scolnick had described a revolution in mental disorders research. He noted that this science was not understood when the NIMH Strategic Plan was devised. If what Dr. Scolnick described is successful, Dr. Desimone felt it would affect every aim and goal in the plan. He suggested that the Council should consider how it can exploit these opportunities in the next 2 or 3 years.

Dr. Levitt noted that pathways such as those described have been known in cancer for some time. Part of the complexity of biology is that these are not static systems, just as a synapse is not static. Rather, these are dynamic signaling systems that are regulated in different ways. Thus, one technological roadblock is lack of understanding the part of the genome that is regulatory. He asked whether the Broad is studying that. Dr. Scolnick agreed that regulatory issues are going to be critical. The mapping approaches in sequencing allow one to map to regions that are non-coding, and that are regulatory. The more detailed maps will allow one to do that even better. He reminded the group that there is an emerging field of non-coding RNAs that are clearly critical for regulating gene expression. In other diseases, some findings map to those regions, but the details are not yet available for mental disorders.

Dr. Paul said that from a therapeutic perspective, even if you only found an allele that increased your risk modestly, it could still indicate a pathway that could be profoundly useful for discovering drugs. As an example, he suggested that if a calcium channel was found to be associated with bipolar disorder, it could be a very good drug target.

Dr. Insel closed the discussion by saying that the genetic collections that already exist can be explored further. For instance, the intact strand of copy-number variations could be studied relatively quickly.

Collaborative Study of Suicidality and Mental Health in the U.S. Army

Robert Heinssen, Ph.D., A.B.P.P., Deputy Director of the Division of Services and Intervention Research (DSIR) described a collaborative initiative undertaken with the U.S. Army. The study is aimed at reducing the incidence of suicide and suicide attempts among Army personnel. He noted that the initiative had been published in the January 5, 2009 NIH guide, which is available on the web  .

Dr. Heinssen explained that the initiative had been undertaken at the request of Secretary of the Army. The Army’s 2007 suicide figures, released in early 2008, showed that the suicide rate among active duty soldiers continued to increase, as it had for several consecutive years. Internal reviews and discussions among the civilian and military leadership within the Army led to the Secretary’s June 2008 request for NIMH involvement. He asked whether there were any research approaches that might uncover risk or protective factors. And, he asked, how would NIMH propose to collaborate with the Army to organize and field a study? The Army conveyed a sense of urgency in addressing the problem. With the release of 2008 suicide statistics showing that the suicide rate had continued to increase among active duty soldiers, the need for the project became even more pressing.

Suicide occurs infrequently in the general population, and none of the known risk factors is powerful enough to identify specific individuals requiring special attention. Suicide risk is probably the combination of multiple factors, or individual factors that might accumulate over time and, in combination, increase an individual's risk. NIMH proposed a framework of translational epidemiology, where the focus would be on identifying risk and protective factors that had not yet been detected in other studies. In addition to considering known risk and protective factors, the study will incorporate innovative approaches for exploring risk architecture and risk mechanisms that will span genes, neurobiological systems, cognitive-emotional domains, social interactions and environmental exposures. A goal of the investigation is to explore how biological, psychological, and interpersonal predispositions interact with the unique experience of being an Army soldier. Among the factors that might contribute to increased risk or protection over the course of an Army career are accumulated training experiences, stressful events, experienced social support from small groups and peers, family interactions, and unique triggering events. Because the Army was interested in new interventions, the research had to be structured in such a way that it would inform the development of empirically derived interventions.

Originally, the Army was primarily interested in studying suicidality, but after discussing the subject internally and with NIMH, it decided to broaden the approach to include the study of mental health. The Army insisted that the research be done quickly and that it have ready and practicable applicability.

The project will require a diversity of expertise–psychiatric epidemiology, psychopathology research, mental illness risk factor research, population survey methods, public health, suicide risk and intervention research, psychological resilience/hardiness, prevention science, clinical trial design and implementation, data management and analysis, and statistics/biostatistics. Research teams with expertise in these areas are expected to come together and, using a consortium mechanism, propose how they would address the problem. A single award will be given to the best-qualified team. The Army and the Department of Defense have allocated a total of $50 million for this 5-year project. Dr. Heinssen closed his presentation by reiterating that the Army insisted that the project be considered urgent and not be approached as “business as usual.”

In the discussion that followed, Dr. Ralph raised the issue of cultural barriers to seeking treatment within the military. He said that the project presents an opportunity to examine the stigma associated with mental health treatment and find ways to overcome it.

Dr. Bell asked whether suicide rates are higher among National Guard soldiers than those in the regular Army, who seem to be more protected. Dr. Heinssen said that the project will include active duty and the reserve personnel, as well as National Guard soldiers.

Dr. Canino noted that the military has a large percentage of minority individuals, and she suggested that this project should study how suicide prevention strategies and risk and protective factors vary by ethnic group. Dr. Ralph and Dr. Canino thought an emphasis on identifying predisposed individuals during recruitment might be important.

Concept Clearances

Research on Biomarkers for Mental Disorders
Wayne Goodman, M.D., Director of the Division of Adult Translation and Treatment Development Research described an initiative aimed at the identification, characterization, and validation of biomarkers and/or biosignatures (integrated profiles of biomarkers and behavioral indicators) of major mental disorders.

One of the greatest challenges for management of mental disorders in the post-genomic era is to “catch up” with the rest of clinical medicine with respect to diagnostic, prognostic, therapeutic, and preventive strategies based on the relevant biology, pathogenesis, and pathophysiology of the disorders of interest. Physicians in many specialties are now able to call upon a vast array of directly relevant biomarkers to accomplish this cardinal task. By contrast, physicians treating mental disorders rely almost exclusively on clinical observation and historical data obtained from patients and other informants.

Numerous biomarkers are available for use in routine medical practice of diagnosis, prevention and treatment. For example, the management of diabetes has been aided by the availability of the serum biomarker hemoglobin A1c. In the case of cardiovascular disease, there are biomarkers that confirm a later stage event (e.g., cardiac enzymes for myocardial infarction) or help predict disease risk or response to treatment (e.g., lipid profile, C-reactive protein). Despite tremendous progress in basic neuroscience, not a single biomarker has been developed with established clinical use in the management of major mental disorders outside the area of substance abuse.

This initiative aims to break this intellectual logjam by reaching well beyond NIMH’s typical applicant pool and encouraging high levels of innovation. Many of the elements necessary for a successful outcome are close at hand. Emerging molecular tools and screening methods relevant to mental disorders are becoming more robust at a logarithmic rate. Efforts to identify and characterize susceptibility genes for schizophrenia and bipolar disorder appear to be bearing fruit. New and promising imaging tools continue to be developed. In all, the scientific landscape appears to offer fertile ground for biomarker/biosignature discovery. Attracting a broader array of innovative scientists to the endeavor may be the missing element. As is the case for diabetes mellitus, it is widely assumed that the current phenotypes of major depression, bipolar disorder, schizophrenia, autism spectrum disorders, and obsessive-compulsive disorder reflect “families” of etiologically heterogeneous disorders. Accordingly, biomarkers may not map precisely onto the current nosological system. A biomarker (or biosignature) may be associated with either a subtype or endophenotype of an existing disorder; it may also correspond to a dimension or domain of pathology (e.g., psychosis) that cuts across multiple disorders.

The identification, characterization and validation of biomarkers/biosignatures for the major mental disorders would facilitate accurate prediction of disease risk, course, and therapeutic responses and ultimately lead to knowledge-based treatment and preventive strategies.

Building a Longitudinal Mental Health Tracking System
Denise Juliano-Bult, M.S.W., DSIR, described the impetus for this initiative as the need for access to timely, detailed, population-based data on prevalence and correlates of mental illness. NIMH and the scientific community need the data to document the public health impact of research and to help define new areas for research investment. Public and private policy makers need the information to provide an evidence base for their decision making.

Past NIMH efforts to document the incidence and prevalence of mental disorders include the epidemiological catchment area study; the National Co-morbidity Study; and the Collaborative Psychiatric Epidemiology Surveys, which included the National Latino and Asian American Study. Useful as these studies are, they provide only cross-sectional data. And, the data represent the United States as a whole so that it is impossible to assess the effect of such influences as state initiatives or localized events (e.g., natural or other disasters). NIMH had borne the principal cost of constructing the sampling frames and collecting the basic health and sociodemographic data in these past efforts.

The current initiative is intended to overcome these drawbacks. The goal is to develop an ongoing process that can deliver timely data on the prevalence, severity, age of onset and correlates of mental disorders–overall and across time, geography, and life course. Data will also be collected on access to mental health care, its adequacy and cost, and the volume of services provided. Disparities in health and health care will be tracked by oversampling populations of interest. Children will be targeted, including children with autism. The project will also provide the ability to collect biological materials. The data will be used to analyze trajectories and trends of disorders, services use, and outcomes.

The initiative aligns with the objectives of the NIMH Strategic Plan, specifically Strategic Objective 2: Chart Mental Illness Trajectories to Determine When, Where, and How to Intervene and Strategic Objective 4: Strengthen the Public Health Impact of NIMH-Supported Research. The initiative also responds to recommendations from the Council report, The Road Ahead.

The initiative would build on existing Federal survey efforts to enable cost-efficient longitudinal tracking and collection of data related to geographic variation, key subgroups, salient exposures, and biomarkers. Candidate surveys include, for example, the ongoing National Household Survey on Drug Abuse, a SAMHSA survey; the CDC’s National Health Interview Survey, and the Behavioral Risk Factors Surveillance System. Each of these surveys collects detailed health and sociodemographic data annually from very large population samples. Each also collects basic mental health data, using the K6 mental health screening tool. The new initiative will use these existing survey infrastructures to target sub-samples of respondents identified by the K6 and conduct detailed follow-up interviews.

Dr. Levitt suggested that the follow-up should include detailed medical health data in addition to the mental health components because co-occurring medical conditions and mental health disorders provide an avenue to understanding heterogeneity. Dr. Insel said that this survey would supplement the CDC tracking system, which focuses on medical conditions.

Implementing a Strategic Plan for Autism Spectrum Disorder Research
Ann Wagner, Ph.D., DDTR, prefaced her description of the autism spectrum disorder (ASD) initiative by reviewing recent developments in the field. The 2006 Combating Autism Act mandated the establishment of an Interagency Autism Coordinating Committee (IACC), a Federal advisory committee, with members appointed by the Secretary of Health and Human Services. The committee includes the heads of Federal agencies conducting ASD-related activities (or their delegates), as well as members of the public. The Act charged the IACC with developing a strategic plan for ASD research that would be submitted to the Congress and updated annually. The IACC gave its final approval of the Strategic Plan in early February 2009.

The plan has nearly 40 short- and long-term objectives that are intended to fill gaps and overcome hurdles that hinder progress in the field. Short-term objectives—those that could be accomplished in 2-5 years—include developing diagnostic and screening tools; establishing a network of international biobanks with standardized protocols; recruiting 20,000 subjects for genome-wide association studies and 1,200 for sequencing studies; merging or linking databases; addressing heterogeneity, identifying biomarkers, and developing model systems; conducting clinical trials; and understanding variations and access to services in diverse populations.

Scientific staff from all the Institutes has carefully selected the objectives that have the potential for an early start with FY 2009 funds. The funding mechanisms will depend on the money allocated, including some that may be NIH-wide omnibus RFAs or activities. The recommended priorities include:

  • Sponsor treatment and services intervention trials, including pilot studies (R34 grants), planning grants, and randomized clinical trials or effectiveness studies.
  • Conduct studies on the impact of variations and access to services in diverse populations.
  • Undertake a public-private partnership to enhance brain and tissue banking.
  • Enhance collection of DNA and phenotyping in existing studies.
  • Hold a scientific workshop and begin a new initiative for pilot studies to develop model systems that replicate features of autism spectrum disorders (ASDs).
  • Address the heterogeneity of ASD, by validating an efficient diagnostic instrument for ASD for use in large-scale studies, understanding mechanisms (e.g., gene-environment interaction) underlying different developmental trajectories (e.g., regressive autism), identifying biological signatures of change in core symptoms across the life span, and conducting preclinical or proof-of-concept studies targeting mechanisms underlying core symptoms.

In answer to a question from Ms. Iversen, Dr. Wagner said that the plan to merge biobanks would be worldwide if the details could be worked out. Ms. Iversen asked what type of model systems were envisioned—animal models or neuro-nets. Dr. Wagner said that the term was meant broadly. Ms. Iversen noted that in light of the research described by Dr. Scolnick she was concerned about the goal of enhancing phenotyping in the DNA collections, since it is extremely expensive. When such huge strides are being made in molecular genetics, it may not be wise to invest in more behavioral phenotyping. To keep adding to the data on observable behavior may not be the most useful strategy for understanding the genetics of ASD.

Identification and Characterization of Sensitive Periods for Neurodevelopment in Studies of Mental Illness
Julia Zehr, Ph.D., DDTR, discussed an initiative aimed at stimulating neurodevelopmental research in humans and animals that will increase our understanding of the neurobiology underlying developmentally sensitive periods for risk, resilience, and intervention.

The goal of this initiative is to accelerate and stimulate research on sensitive periods (i.e., periods during which the developing brain is maximally sensitive to environmental influences that confer risk or resilience) for the neurodevelopment of mental illness. While brain development may start from a genetic blueprint, it is the overlay of experience that shapes development and leads to either normal function or psychopathology. We have limited knowledge of either the timing and specificity of sensitive periods in humans or the neurobiological trajectories in mental disorders. By increasing research focused on sensitive periods in behaviors related to mental health, the field will make exponential progress in the treatment of mental illness. Furthermore, with more fundamental information on sensitive periods in humans, we can develop more specific and focused hypotheses about mechanisms to be tested in preclinical animal models. Therefore, the potential advances gained from this initiative are essential for the ultimate understanding, prevention, and cure of mental disorders.
This initiative would support investigations of sensitive periods in the development of cognitive or affective function and behaviors relevant to mental health disorders. In particular, applications may address sensitive periods in the development of normal function or psychopathology, as well as sensitive periods for intervention to prevent, pre-empt, and/or treat mental illness, and the mechanisms underlying the interaction between genetics, experience, and development.

Taken together, these types of studies would greatly advance understanding of the developmental trajectories of mental illness and would allow better identification of risk and protective factors, as well as novel interventions and treatments. This concept was developed as a direct consequence of the Council’s neurodevelopment workgroup report, and it follows its recommendations and research priorities. It is also aligned with the Strategic Plan.

Dr. Lewis said he would like to see this initiative dovetail with the autism strategic plan, particularly considering environmental factors, early risk factors, and immune factors.

Following the discussion, the Council voted to unanimously approve all four concept clearances that were presented.

Public Comment

Colonel E. Cameron Ritchie, Medical Director of the Army Medical Department’s Office of Strategic Communications and a psychiatrist in the Army Surgeon General's Office, said she is hopeful that the partnership between the Army and NIMH will produce a major public health intervention. She emphasized that much is already known about the risk factors for suicide, including the stress of repeated deployments. What is not known is how to stop people from killing themselves. What are needed are suicide intervention strategies that work.

Dr. Insel reminded Council members that the next meeting would be held on May 28-29, 2009. With that he adjourned the meeting.

Adjournment

Dr. Insel adjourned the 220th meeting of the NAMHC at 12:30 p.m. on February 13, 2009.

I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.

__________________________________
Thomas R. Insel, M.D., Chairperson

Appendix A

Summary of Primary MH Applications Reviewed
Council: February 2009

Category IRG Recommendation
  Scored # Scored Direct Cost $ Not Scored (NRFC)# Not Scored (NRFC) Direct Cost $ Other # Other Direct Cost $ Total # Total Direct Cost $
Research 490 $553,580,541.00 371 $342,094,957.00 0 $0.00 861 $895,675,498.00
Research Training 58 $98,693,499.00 9 $11,425,058.00 0 $0.00 67 $110,118,557.00
Career 63 $44,274,692.00 15 $10,341,948.00 0 $0.00 78 $54,616,640.00
Other 77 $55,602,082.00 40 $22,951,540.00 1 $322,067.00 118 $78,875,689.00
Totals 688 $752,150,814.00 435 $386,813,503.00 1 $322,067.00 1124 $1,139,286,384.00

Appendix B

(Terms end 9/30 of designated year)

Chairperson Executive Secretary
Thomas R. Insel, M.D.
Director
National Institute of Mental Health
Bethesda, MD
Jane A. Steinberg, Ph.D.
Director
Division of Extramural Activities
National Institute of Mental Health
Bethesda, MD
Members
David G. Amaral, Ph.D. (12)
Professor
Department of Psychiatry
The M.I.N.D. Institute
University of California, Davis
Sacramento, CA

Carl C. Bell, M.D. (11)
President and CEO
Community Mental Health Council and Foundation, Inc.
Chicago, IL

Glorisa J. Canino, Ph.D. (09)
Director, Behavioral Sciences Research Institute
University of Puerto Rico
Medical Sciences Campus
San Juan, PR

Elizabeth Childs, M.D., P.C. (10)
Private Practice
Brookline, MA

Robert Desimone, Ph.D. (11)
Director, McGovern Institute for Brain Research
Massachusetts Institute of Technology
Cambridge, MA

Ralph J. DiClemente, Ph.D. (12)
Candler Professor
Department of Behavioral Sciences and
Health Education
Rollins School of Public Health
Emory University
Atlanta, GA

Howard B. Eichenbaum, Ph.D. (12)
Professor and Director
Center for Memory and Brain
Department of Psychology
Boston University
Boston, MA

Daniel H. Geschwind, M.D., Ph.D. (11)
Director and Professor
University of California, Los Angeles
Los Angeles, CA

Steven M. Paul, M.D. (12)
Executive Vice President
Science and Technology
President, Lilly Research Laboratories
Eli Lilly and Company
Indianapolis, IN

Enola K. Proctor, Ph.D. (10)
Frank J. Bruno Professor of Social Work Research
Washington University in St. Louis
St. Louis, MO

Portia E. Iversen (12)
Co-Founder
Cure Autism Now Foundation and
Autism Genetic Resource Exchange
Los Angeles, CA

Dilip V. Jeste, M.D. (10)
Estelle and Edgar Levi Chair in Aging
Distinguished Professor of Psychiatry and
Neuroscience
Stein Institute for Research on Aging
University of California, San Diego
La Jolla, CA
Norwood Knight-Richardson, M.D., M.B.A. (09)
Vice Chairman of Department of Psychiatry
Director of the Public Psychiatry Training Program
Director of Oregon Health and Science University
Neuropsychiatric Institute
Oregon Health and Science University
Portland, OR

Pat R. Levitt, Ph.D. (09)
Professor, Department of Pharmacology
and Director, Vanderbilt Kennedy Center for
Research on Human Development
Vanderbilt University
Nashville, TN

David A. Lewis, M.D. (11)
Director, Translational Neuroscience Program
University of Pittsburgh
Pittsburgh, PA

John S. March, M.D., M.P.H. (10)
Professor of Psychiatry and Behavioral Sciences
Director, Division of Neurosciences Medicine
Duke Clinical Research Institute
Duke University Medical Center
Durham, NC

Thomas H. McGlashan, M.D. (12)
Professor
Department of Psychiatry
Yale University School of Medicine
New Haven, CT

Ex Officio Members
Office of the Secretary, DHHS
Kathleen Sebelius
Secretary
Department of Health and Human Services
Washington, DC

National Institutes of Health
Raynard S. Kington, M.D., Ph.D.
Acting Director
National Institutes of Health
Bethesda, MD

Veterans Affairs
Ira Katz, M.D., Ph.D.
Department of Veterans Affairs
Office of Mental Health Services
Washington DC

Department of Defense
John A. Ralph, Ph.D.
Commander, U.S. Navy
National Naval Medical Center
Bethesda, MD

Liaison Representative
A. Kathryn Power, M.Ed.
Director, Center for Mental Health Services
Rockville, MD