NAMHC Minutes of the 240th Meeting

February 6, 2015

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 240th meeting in closed session at 8:00 a.m. on February 6, 2015 at the Neuroscience Center in Rockville, Maryland, to review the report from the Board of Scientific Counselors, the group that provides scientific oversight for the NIMH Division of Intramural Research Programs (IRP). This portion of the meeting recessed at approximately 8:45 a.m. The NAMHC then reconvened in open session at 9:00 a.m. and adjourned at approximately 2:30 p.m. In accordance with Public Law 92-463, the policy session was open to the public. The NAMHC reconvened for a closed session to review grant applications at 3:00 p.m. on February 6, 2015, at the Neuroscience Center in Rockville, Maryland, until adjournment at approximately 5:00 p.m. (See Appendix A: Review of Applications). Thomas Insel, M.D., Director of the National Institute of Mental Health (NIMH), presided.

Council Members Present at the Grant Review and/or Open Sessions

(See Appendix B: Council Roster)

Chairperson

• Thomas R. Insel, M.D.

Executive Secretary

• Jane A. Steinberg, Ph.D.

Council Members

• Patricia Areán, Ph.D.
• Deanna M. Barch, Ph.D.
• David A. Brent, M.D.
• B.J. Casey, Ph.D.
• Randall L. Carpenter, M.D.
• Benjamin G. Druss, M.D., M.P.H.
• Lisa Greenman, J.D.
• Hakon Heimer, M.S.
• Michael F. Hogan, Ph.D.
• Richard L. Huganir, Ph.D.
• Steven E. Hyman, M.D.
• Marsha M. Linehan, Ph.D.
• Maria A. Oquendo, M.D.
• Gene E. Robinson, Ph.D.
• Mary Jane Rotheram, Ph.D.
• J. David Sweatt, Ph.D.
• Carol A. Tamminga, M.D.

Ex Officio Members

• John W. Davison, M.B.A., Ph.D. Department of Defense (DoD)
• Ira Katz, M.D., Ph.D., Department of Veterans Affairs

Liaison Representative

• Paolo Del Vecchio, M.S.W.

Others Present at the Open Policy Session

• Alisa Bernard, International Bipolar Foundation
• Lizbet Boroughs, American Psychiatric Association
• Brianna Braskill, Purdue University
• William Carpenter, University of Maryland
• Nathan Counts, Mental Health America
• Tyauna Brown, Synergy Enterprises
• Krystin Douds, NIH Interpreter
• Daniel Foti, Prudue University
• Travis Griffin, NIH Transcriber
• Kathi Hanna, Science Writer
• Bradley Joyce, Purdue University
• John Kane, Hofstra North Shore – LIJ School of Medicine
• Alan Kraut, Association for Psychological Science
• Kevin McNaught, Tourette Syndrome Association
• Steven Saenz, NIH Interpreter
• Angela Sharpe, Consortium of Social Science Associations
• Andrew Sperling, National Alliance on Mental Illness
• TaRaena Yate, Synergy Enterprises

Open Policy Session Call to Order and Opening Remarks

NIMH Director Thomas Insel, M.D. called the open policy session to order and welcomed all in attendance.

Approval of Minutes of the Previous Council Meeting

Turning to the minutes of the September 2014 Council meeting, Dr. Insel asked whether Council members had any comments, revisions, or questions. Receiving none, the Council unanimously passed the motion to approve the minutes.

NIMH Director’s Report

Dr. Insel asked members of Council to introduce themselves, reviewed the agenda for the open policy session, and provided an update on activities related to NIMH.

At the White House level, President Obama announced the Precision Medicine Initiative  (PMI) during his January 2015 State of the Union Address. At a subsequent East Wing speech that brought together medical leadership and research advocates, the President presented a proposed budget for the PMI, including $130 million to the National Institutes of Health (NIH) to develop a national research cohort of at least one million volunteers, with the prospect of open, responsible data sharing; $70 million for the National Cancer Institute (NCI) to scale up efforts to identify genomic drivers in cancer and apply that knowledge in the development of more effective approaches to cancer treatment.; $10 million for the Food and Drug Administration (FDA) to acquire additional expertise and advance the development of high quality, curated databases to support the regulatory structure needed to advance innovation in precision medicine and protect public health; and, $5 million to the Office of the National Coordinator to support the development of interoperability standards and requirements that address privacy and enable secure exchange of data across systems. The study plan will be refined by the Advisory Committee to the Director (ACD) of NIH.

With regard to Congress, Dr. Insel discussed new committee leadership in the 114th Congress. He noted the high level of activity in Congress on biomedical research issues, particularly related to the 21st Century Cures Initiative , led by Representatives Fred Upton (R-MI) and Diana DeGette (D-CO) of the House Energy and Commerce Committee. The initiative aims to: 1) incorporate patient perspectives into the regulatory process; 2) spur a new generation of cures; 3) modernize clinical trials and data sharing; 4) improve the regulatory process for federal health agencies; and 5) update regulations for medical devices. It calls for the development of an overall NIH Strategic Plan with a focus on support for early-stage investigators, the Common Fund , the Brain Research through Advancing Innovative Neurotechnologies  (BRAIN) Initiative, and surveillance of neurological disorders. This effort is now available for public comment; a similar but separate effort in the Senate is described in a report issued by Senators Lamar Alexander (R-TN) and Richard Burr (R-NC). The Senate effort also addresses regulatory issues, drug development, support of basic science, and an improved clinical trials system.

Rep. Tim Murphy (R-PA) continues to hold town hall meetings to discuss the U.S. mental health system. The Helping Families In Mental Health Crisis Act  would establish an Assistant Secretary for Mental Health; focus on serious mental illness (SMI); and address several policy challenges for people with SMI, such as bed shortages, the Medicaid “one doctor a day” rule, Health Insurance Portability and Accountability Act (HIPAA) restrictions, the need for secondary prevention, translation of research into practice, and integration of mental health and physical health.

At the Department of Health and Human Services (HHS) level, Substance Abuse and Mental Health Services Administration(SAMHSA)Administrator Pamela Hyde has convened a new working group to review SMI issues related to common measures, early intervention, and workforce issues. In addition, FDA Commissioner Peggy Hamburg announced she is stepping down.

At the NIH level, the Common Fund awarded 12 Center grants for $31 million aimed at enhancing diversity in the biomedical, behavioral, clinical, and social sciences research workforces. This program, referred to as the NIH Building Infrastructure Leading to Diversity initiative, aims to build infrastructure leading to enhanced diversity of the biomedical workforce, to support mentoring networks, and to fund a coordination and evaluation center.

A second NIH-level issue concerns NIH-supported clinical trials, and in particular, how long trials take to conduct and how few trials publish results within 100 months of completion. These concerns underscore a critical need for greater transparency and efficiency. NIH recently issued a Notice of Proposed Rulemaking that would require registration and results submission to ClinicalTrials.gov for all NIH-funded clinical trials. The public comment period ends February 19, 2015. Another issue concerning NIH-supported clinical trials is the necessity of using multiple Institutional Review Boards (IRBs) to get approval for multi-site clinical studies, a process which may delay important research without necessarily improving oversight. NIH currently has a draft policy out for public comments that would permit the use of a single IRB identified by the principal investigator for multi-site studies.

Turning to the budget, Dr. Insel noted the passage of the fiscal year (FY) 2015 appropriation. The NIH received $30.31 billion, a slight increase over the previous year but still lower than the budget of FY 2012. Special items included $25 million for the BRAIN Initiative ($60 million had been requested) and $238 million for Ebola research. This budget translates into a general increase for Institutes and Centers of 0.3 percent over FY 2014. NIMH received $1.4 billion, a $17 million increase over the NIMH FY 2014 appropriation.

The President’s FY 2016 proposed budget was released February 1 requesting $31.1 billion for NIH with specific increases for PMI ($200 million) and BRAIN ($70 million). Sequestration may return for FY 2016, potentially resulting in a 5 percent across-the-board cut. The FY 2016 President’s budget request includes $1.5 billion for NIMH, a $56 million increase over FY 2015. It includes a $23 million increase in BRAIN Initiative funding and an increase of $5 million for PMI.

Despite the fact that the budget has reverted, in terms of real dollars, to FY 1999 levels, NIMH’s success rate has hovered around 19 percent. That said, the number of applications are up this year, resulting in an estimated success rate of about 18 percent for 525 awards in FY2015. NIMH does not have an absolute payline and tries to support three-fourths of the grants under the 20th percentile. Studies have shown no evidence that the grants under the 10th percentile have a greater impact in the long run than those under the 20th percentile. As all of those grants are scientifically meritorious, NIMH also makes decisions based on portfolio balance and relationship to the NIMH mission.

Dr. Insel closed by congratulating LeShawndra Price, Ph.D. from the NIMH Office of Research on Disparities and Global Mental Health for receiving the American Psychological Association Meritorious Research Services Commendation and Susan Amara, Ph.D., Director, IRP, for receiving the Julius Axelrod Prize from the Society for Neuroscience.

Discussion

Carol Tamminga, M.D., noted the lack of a mechanism or place to report negative clinical trial data. In response, Dr. Insel discussed the importance of the NIMH Database for Clinical Trials Related to Mental Illness (NDCT), discussed at prior meetings, the success of which will require submission of data, both positive and negative. He added that even with positive trials, results sometimes convert to negative after reanalysis.

Marsha Linehan, Ph.D., asked what is being done to encourage investigators to submit data. Dr. Insel agreed that this is an important need, requiring retraining and additional resources to help support submission. NIMH has announced the availability of administrative supplements to create common data elements and new standards. Important groundwork was laid through the National Database for Autism Research  (NDAR), which demonstrated that such databases take time to build, including time spent with the targeted community explaining the process.

Steven Hyman, M.D., added that experience with the Psychiatric Genomics Consortium revealed that researchers need help learning how to use big databases in a secure manner. Dr. Insel responded that the NDCT uses global unique identifiers (GUIDs) to protect privacy. He added that NIMH has been taking a close look at the NIMH investment in clinical trials and is implementing some of the recommendations of the NAMHC Workgroup focused on intervention development. As a result of this review, NIMH has decreased its funding of clinical trials by approximately 50 percent overall. Of the trials funded, roughly half are examining psychosocial interventions rather than medication trials. Eighty-four percent of the NIMH-funded trials have reported out within 30 months and the mean time for publication is six months from completion of the trial, which is a vast improvement from two years ago.

Deanna Barch, Ph.D., asked if there is a plan to work with multiple institutions regarding the release of individuals' data, particularly for multi-site studies. Will there be common language and consent forms to facilitate sharing? Dr. Insel acknowledged that it is an issue requiring attention. Although institutions know they must share data as a term of the award, IRBs might not be aware of the requirements and might impose varying requirements.

Gene Robinson, Ph.D., asked about the President launching two major initiatives in such a narrow timespan. Dr. Insel said that he is anxious to push these efforts in the time he has left in office and is very committed to both the BRAIN Initiative and PMI, as is the NIH Director.

Hakon Heimer, M.S., asked about the surveillance system for neurological disorders discussed in the 21st Century Cures initiative and whether it suggests that mental illness is not included under the umbrella term of brain disorders. Dr. Insel replied that Chairman Upton understands completely the range of what we would call mental disorders.

Update on the Institute of Medicine (IOM) Report Focused on Developing Evidence-Based Standards for Psychosocial Interventions for Mental Disorders

Patricia A. Areán, Ph.D.
Professor, Department of Psychiatry and Langley Porter Psychiatric Institute, University of California, San Francisco

Dr. Areán reviewed the current status of the IOM report on developing evidence-based standards for psychosocial interventions. This initiative was born out of necessity from the Affordable Care Act, in which one of the stipulations concerning treatment is the need to ensure that patients have access to high-quality care and to measure whether patients are actually receiving it. Historically, psychosocial interventions have not had a standard approach to or consensus about how to evaluate the evidence for effectiveness of interventions. That is, what evaluation is needed to determine that an intervention feasibly meets quality standards? After an intervention is deployed in the service system, how does one know if patients are receiving it? By nature, psychosocial interventions are a little bit of a black box. Behind an office door nobody knows what is going on other than the provider and the patient he or she is working with.

The committee is multidisciplinary and involves many different stakeholders, with representatives from the health care industry, nursing, social work, psychiatry, and clinical psychology. Former Council member Rhonda Robinson Beale also serves. The sponsors included NIH, the Department of Veterans Affairs, SAMHSA, and the HHS Office of the Assistant Secretary for Planning and Evaluation. The American Psychological Association and the American Psychiatric Association also sponsored the study, as well as the National Association for Social Workers. The charge of the committee is publicly available on the IOM website. The committee was asked to develop a framework for standards so that 1) consumers know that they are getting high-quality care; 2) payers know what to pay for; and, 3) there is an incentive for providers to deliver high-quality care through evaluation.

Dr. Areán reviewed the committee’s timeline. It had one year to work together with a contract that began in October 2013. The first meeting occurred in March 2014. The struggle of the first meeting focused on what constitutes quality measurement, that is, the question of whether people are getting better. How does one assess whether people are getting the interventions that clinicians claim they are performing? The committee heard from experts in quality measurement of behavioral health services, surgery, and other fields. Typically, when evaluating the quality of a psychosocial intervention in a clinical trial, one either sits in or audiotapes in order to achieve one-way mirror-style observations. These methods are not easily deployed in the real world. Surgery has a similar problem in that often experts are unable to sit in to verify that the surgery being performed is of high quality. Though slightly different, experts from the surgical industry have begun to address these concerns.

The committee held a public workshop on May 19, 2014. In July 2014, the committee had a meeting on quality improvement, not only in terms of measurement but also in quality of care, with testimony provided by experts in implementation science and measurement of treatment fidelity. As an example, Greg Aarons, Ph.D., who has been supported by NIMH, has developed some unique ways of measuring quality for behavioral interventions, which can marry efficiency and cost containment while ensuring people are delivering interventions of high quality. Experts in health technology addressed the committee on how technology may be leveraged to better determine whether somebody is delivering high-quality interventions.

The report is currently under blinded review by an external board. An external process will be used to monitor the penultimate report and ensure that the committee addresses its charge, and that the recommendations are well supported, non-opinionated, based on the needs and the literature reviewed, and feature high-quality data analysis. The next step is the release of the report, followed by a dissemination meeting, which aims to discuss how to implement the report’s recommendations.

Discussion

Dr. Linehan commented that the topic of the IOM report is a very important issue—if providers can be reimbursed for therapy and psychotherapy regardless of evidence of effectiveness, then those with no training may offer it. She asked if the IOM committee was addressing certification. Dr. Areán responded that recommendations cannot be discussed until they are approved. However, quality improvement and quality measurement can address these issues. For example, surgeons have noted that the first thing to establish quality is to be trained in the intervention. There is research that shows that the number of procedures a surgeon does is inversely related to the number of poor patient outcomes.

Ira Katz, M.D., Ph.D., asked if there should be an FDA for psychosocial interventions. Dr. Areán responded that the IOM committee did address the oversight framework and standards needed for psychosocial interventions, including whether there should be a single body that identifies evidence-based interventions.

Randall Carpenter, M.D., questioned whether this was an issue of regulation or education, rather than compensation. He questioned what is being done to educate patients about seeking providers who produce good outcomes. Dr. Areán answered that there are many ways to ensure that people are informed of the quality of care they are receiving, and that part of the Affordable Care Act allows for reporting on satisfaction with providers. However, more work is needed to inform the public about what is evidence-based and what is not.

Recovery After an Initial Schizophrenia Episode (RAISE): Initial Outcomes from the Early Treatment Program Clinical Trial

John Kane, M.D.
Chairman, Department of Psychiatry
Hofstra North Shore-LIJ School of Medicine

NIMH launched the Recovery After an Initial Schizophrenia Episode (RAISE) Initiative in June of 2008. The RAISE Early Treatment Program (RAISE-ETP) represents the first randomized controlled trial of integrated treatment for first-episode psychosis (FEP) that is delivered in non-academic care settings in the United States. Only a few such studies have occurred outside the U.S., and none have had the methodological strengths of the RAISE-ETP trial. NIMH awarded the RAISE-ETP contract to the Feinstein Institute for Medical Research in July 2009 and enrollment began at 34 community sites in 21 states across the U.S in July 2010.

The RAISE-ETP Executive Committee is made up of more than a dozen nationally recognized researchers representing expertise in the early detection and intervention of psychosis, psychosocial and psychopharmacologic treatments for FEP, health economics, healthcare policy, medical anthropology, and mental health services delivery.

The RAISE initiative aims were: to develop an integrated treatment model for FEP that maximizes individuals’ functioning, promotes their symptomatic recovery, and can be brought to scale in community care settings throughout the U.S.; to compare the intervention to prevailing treatment approaches for FEP in the U.S.; and, to conduct the study in non-academic, U.S. community treatment settings.

The tested intervention is called NAVIGATE. The overall goal of NAVIGATE is the individual’s recovery, not just maintenance. NAVIGATE is a team-based, multicomponent approach that relies on shared decision-making to insure client and family involvement in all phases of treatment planning. R AISE-ETP included training on NAVIGATE intervention components and principles of FEP care and ongoing consultation to ensure fidelity to the NAVIGATE model. NIMH also required that NAVIGATE intervention components be supported through current reimbursement mechanisms.

The NAVIGATE intervention is delivered by team members representing five key roles:

1. The program director establishes referral networks, facilitates enrollment, and assures team cohesion.
2. A physician or nurse practitioner provides FEP-specific pharmacotherapy via a computerized decision support system that was developed for RAISE-ETP. (This system is particularly important because it provides guiding algorithms, patient self-assessment, measurement-based decision making, application of evidence to treatment, and highlights the interface between pharmacotherapy, psychosocial treatment and comorbid medical conditions.)
3. An individual resilience therapist provides recovery-focused education and support and integrated addictions treatment.
4. A family therapist provides family psychoeducational and support and facilitates communication and problem solving. About 80 percent of patients in RAISE-ETP were still living with their family of origin at the time they entered the study.
5. An employment/education specialist facilitates return to school or competitive work and efforts to lead a rewarding life in the community.

RAISE-ETP investigators conducted a randomized controlled trial to compare NAVIGATE to Community Care (usual treatment for FEP) using cluster randomization. With cluster randomization, clinics rather than individual patients are randomized, which is an advantageous approach for disorders such as schizophrenia with a relatively low incidence. Patients were recruited and engaged in treatment at the community sites and treated for a two-year period. Assessments of primary and secondary clinical outcomes were conducted remotely and completed by centralized raters using live two-way video.

Thirty-four community clinics in 21 states participated in the study with broad distribution across the U.S. The NAVIGATE and Community Care sites were matched on geography and residents’ socioeconomic status. Of the 404 patients with FEP enrolled in RAISE-ETP, 223 patients received FEP care at the 17 NAVIGATE sites and 181 at the 17 Community Care sites. To be eligible for the study, patients had to be between the ages of 15 and 40 years; have a Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID)-confirmed diagnosis of schizophrenia, schizophrenia-like disorder, schizoaffective pre-psychotic disorder, or psychosis not-otherwise-specified; have no more than six months’ lifetime antipsychotic medication exposure; and be experiencing their first episode of psychosis. The SCID was repeated a year later to determine whether the original diagnostic impression was correct.

The primary outcome measure was the Heinrichs-Carpenter Quality of Life Scale. The key secondary outcome measures included the Positive and Negative Syndrome Scale (PANSS); the Calgary Depression Rating Scale for Schizophrenia; the type and amount of treatment received; and, school and employment activities.

At time of enrollment, the average patient age was 23 years for both groups. More males were in the NAVIGATE sites, and there was a trend toward more African Americans in the Community Care sites. Patients in Community Care were more likely to be in school and more likely to have had a prior hospitalization. Psychiatric diagnoses at baseline were similar for both conditions.

Using the Service Use and Resource Form, patients were asked their perceptions of the services they received in the four key intervention domains, including time to receipt of the service. Overall, patients in NAVIGATE received far more of the intended services than did those in Community Care. NAVIGATE patients were much more likely to have received supported employment and education services, resiliency-focused individual therapy, structured medication assessments by the prescriber, and family therapy, as compared to patients in Community Care. NAVIGATE participants also stayed in treatment significantly longer.

Using the Heinrichs-Carpenter Quality of Life Scale and controlling for baseline differences seen in the cluster randomization, the NAVIGATE patients’ quality of life was significantly higher than for patients in Community Care. While NAVIGATE patients had a significantly lower rate of involvement with work or school at baseline, they showed a much greater increase in work or schools days per month, as compared to those in Community Care.

The PANSS rating scale was used to assess psychopathology in schizophrenia and includes positive and negative symptoms, as well as general psychopathology. NAVIGATE participants experienced more rapid reduction in symptoms of psychopathology between baseline and six months, as compared to Community Care patients. While NAVIGATE patients sustained those gains, this difference was not significantly different from the Community Care patients at two years.

Depression is often a co-occurring condition in patients with schizophrenia, particularly following the FEP. On the Calgary Depression Scale for Schizophrenia, NAVIGATE patients had lower levels of depression at 6 and 24 months as compared to Community Care Patients.

There was no significant difference in time to first psychiatric hospitalization. Thirty-four percent of patients in the NAVIGATE treatment were re-hospitalized at least once during the course of the two-year follow up period, compared to 37 percent of the patients in Community Care. These results are not inconsistent with many other FEP treatment studies. Similarly, the two conditions did not differ in visits to emergency rooms.

The median duration of untreated psychosis in this sample was 74 weeks. Patients with a duration of untreated psychosis shorter than 74 weeks derived significantly more benefit from the NAVIGATE intervention than did those who had a longer duration of untreated psychosis. For patients in Community Care, no such relationship was observed. This suggests that administering the proper treatment at the proper time can have an important impact on patient outcome.

Future analyses of RAISE-ETP data include cost-effectiveness of NAVIGATE and predictors of treatment effects, including the influence of age, gender, race, and ethnicity; cognitive functioning; insight; substance abuse and dependence; trauma history; health insurance status; and Intent to attend and complete the study. There is also interest in the adverse metabolic effects and comorbid medical conditions of many of the RAISE-ETP participants. RAISE-ETP researchers published a paper on participants’ baseline rates of smoking and cardiometabolic risk status. RAISE-ETP researchers also published papers on the duration of untreated psychosis and medication management practices prior to entrance in the study.

In conclusion, NAVIGATE patients were significantly more likely to remain in treatment, experienced greater improvement in quality of life (the primary outcome measure), and were significantly more likely to be working or going to school. Over 24 months, NAVIGATE and Community Care patients showed similar improvements in psychopathology but NAVIGATE participants showed a significantly greater degree of symptom improvement during the first 6 months of treatment and maintained those gains. Duration of untreated psychosis appears to be an important moderator of NAVIGATE effectiveness. These results show that a coordinated specialty care model for FEP can be implemented in a diverse range of community clinics and that quality of life of for patients with FEP can be significantly improved.

Dr. Kane expressed gratitude to RAISE’s core collaborators and consultants; NIMH staff; the many clinicians, research assistants, and administrators at participating sites; and the patients and families who made this study possible.

Discussion

Dr. Tamminga asked what is included in the primary outcome measure of quality of life and about the untreated psychosis findings. Dr. Kane responded that it is a combination of multiple subscale measures, including symptoms, instrumental role functioning, community activities, and interpersonal relationships. Dr. Kane further explained that poor premorbid functioning does not necessarily mean that the patients had psychotic symptoms during the entire premorbid period. Potentially, they were asocial but not psychotic. In some studies, the duration of untreated psychosis has been much shorter.

Dr. Tamminga also asked about the finding of no differences in time to re-hospitalization. Dr. Kane explained that the hope was to reduce hospitalization, but it is a complex outcome measure. Sometimes people are hospitalized because they are being watched more closely or because they are not being watched at all. Dr. Kane noted that the investigators need to conduct more analyses to understand the factors that predispose people to hospitalization, and then consider what interventions might supplement comprehensive FEP care to facilitate a reduction in hospitalizations.

Dr. Barch asked if there is anything from the RAISE data that provides clues about clinical characterization, demographics, or geography. Dr. Kane said that there were certain variables that were associated with longer duration of untreated psychosis, including male sex, greater severity of psychopathology, and more substance abuse.

Dr. Oquendo asked how the NAVIGATE team was identified, trained, and monitored and whether there was a need for corrective feedback over time. Dr. Kane replied that NAVIGATE team members were selected from the treatment sites’ existing clinical staff and received face-to-face training, followed by consultation via conference calls and videotapes and audiotapes for review. Manuals for each treatment domain are available on the website http://www.raiseetp.org . Treatment quality was monitored using a series of fidelity metrics. Dr. Kane observed that NAVIGATE team members naturally differ in their clinical skill levels and that can affect outcomes.

Mr. Heimer asked if this initiative could be a paradigm for other disorders, and whether there was enough data to determine if some patients might have had bipolar disorder. Dr. Kane said the number of people who actually converted to a diagnosis that did not involve psychosis was low.

Dr. Linehan recommended that attention be paid to differences among therapists regarding the decision to hospitalize. Hospitalization might be iatrogenic for some patients and its effects need to be better understood. Dr. Kane added that there were no suicides during the course of the trial but there was one serious attempt.

Michael Hogan, Ph.D. said that the study has shown the value of early versus late intervention and has demonstrated the feasibility of an intervention for FEP in real-world settings.

J. David Sweatt, Ph.D. asked if there is evidence that antipsychotic medication might improve outcomes from an initial psychotic episode and whether excluding those with more than a six-month lifetime exposure to antipsychotics might have biased the study. Dr. Kane said that the goal was to arrive at the right balance between feasibility and scientific desirability. Ideally, it would be better to treat patients even earlier, but that may not be feasible for a study this large in community clinics. Nonetheless, the use of antipsychotic medications during the early phase of psychosis is very important if used judiciously.

Dr. Linehan noted that some manualized treatments tend to be better than treatment as usual, and asked whether the study taped the treatment-as-usual providers. Dr. Kane said that the investigators did not want to have a presence at the usual care sites, other than to conduct the research assessments that were necessary to the trial. Dr. Insel added that these community sites are probably providing better usual care than would be found in many parts of the country, based on their interest in FEP care and desire to participate in the study.

Dr. Insel said that one of the initial goals of the study was to see if costs could be reduced in terms of reduced re-hospitalization. While that does not yet appear to be the case, the NAVIGATE group does seem to be having better outcomes in terms of return to work and school, something that should continue to be followed. Potentially, recovery will have to be redefined. Dr. Insel reminded Council that the RAISE concept came out of Council recommendations; thus, Council also deserves credit for its successes so far.

Concept Clearances

Dr. Insel remarked that the concept presented today is of interest, but whether it is implemented depends on NIMH funding.

Early Psychosis Intervention Network (EPINET)

Robert Heinssen, Ph.D., ABPP
Director, Division of Services & Interventions Research, NIMH

Several factors in recent years have combined to create a more receptive environment for the notion of early intervention in SMI. These include the success of the RAISE project, stipulations of the Affordable Care Act, and increased NIMH communication with key stakeholders. In January 2014, Congress allocated an additional $24.8 million to SAMHSA’s community mental health block grant program, specifically to introduce evidence-based treatment for early SMI. Congress directed SAMHSA and NIMH to work together to identify the most promising approaches for treating FEP and to develop guidance for the states about how to implement evidence-based care.

NIMH and SAMHSA have reviewed the plans developed by the 50 states for this mental health block grant set-aside, identifying 29 states that have committed to implementing evidence-based coordinated specialty care for FEP. These 29 programs almost double the number of states with coordinated specialty care programs for FEP, compared to 2013.

NIMH estimates that if all states follow through on plans submitted for set-aside funds, there will be approximately 100 FEP specialty care clinics in the United States by October 2016. Signaling ongoing commitment to early intervention, Congress continued the FEP set-aside to the community mental health block grant program in FY 2015.

The framework of learning health care systems, as first proposed in a 2012 IOM report, is measurement-based treatment where clinical encounter data drive quality improvement efforts as well as scientific inquiry. A continuously learning system is achieved by organizing health care around standardized measures of patient characteristics, interventions, and outcomes; informatics platforms for collecting and aggregating individual-level data elements; and big data analytics for analyzing, interpreting, and reporting those data in real time.

This initiative aims to create a national learning healthcare system among treatment centers that offer evidence-based specialty care to persons experiencing subthreshold psychotic symptoms or a FEP. The Early Psychosis Intervention Network (EPINET) will link coordinated specialty care clinics through common data elements for early psychosis, data sharing agreements, and a unified informatics approach for aggregating and analyzing pooled data. The twin goals of EPINET are to improve the quality of care delivered to persons with early psychosis and to cultivate a culture of collaborative research participation in academic and community early psychosis clinics.

The effort to identify standardized measures can capitalize on existing NIMH efforts to develop common data elements for PTSD, suicide, and eating disorders. EPINET can also capitalize on informatics approaches developed by the Patient-Centered Outcomes Research Institute, as well as approaches used in the National Center for Advancing Translational Sciences. Lessons learned from RAISE about the need for ongoing partnerships with key stakeholders, including service users, clinicians, health care administrators, and scientists, will also inform the effort.

A three-year program is expected to yield: common data elements to characterize early phases of psychotic illness; a unified informatics approach for connecting up to 20 coordinated specialty care programs; and, pilot projects for collecting biological measures and assessing key outcomes from 500-1000 early psychosis patients.

Discussion

Dr. Hogan said that he is impressed with the focus on creating a cycle of rolling research findings into practice. There is a need for infrastructure to track patients over the timeline of the treatment and to define the quality of treatment activities. Creating community behavioral health clinics with uniform infrastructure will facilitate this goal.

Dr. Carpenter applauded these efforts to conduct research in neuropsychiatric disorders in humans, and focusing on preventing the progression of schizophrenia. He encouraged NIMH to include genomics, metabolomics, and assessments of circuit function or imaging to better understand functional outcomes.

Dr. Linehan also expressed support for the concept and the methodology, urging it to be adopted across other disorders. It will be critical to involve clinicians in collecting and submitting data.

Mary Jane Rotheram, Ph.D., said that the importance of this effort is in setting up a ‘learning collaborative’ in which it is routine to monitor practice. It will be critical to monitor training of practitioners to ensure that they are all providing services in the same way.

Paolo Del Vecchio, M.S.W., said it is exciting to see states leveraging the block grant resources to expand beyond the allocations awarded by SAMHSA. For example, Virginia is allocating six times the amount received through the block grant allocation. However, because the funds are based on a formula grant, some states and territories receive a small amount and it is therefore more challenging for them to fully implement the model.

Dr. Robinson commented that EPINET is precision medicine for mental illness and encouraged NIMH to frame it that way to take advantage of the new initiative. In response, Dr. Heinssen said that because EPINET will be looking at outcomes and related measures, which could include genome sequencing, it has the benefit of creating a more robust picture of the disease and a higher level of individualized engagement than many of the programs being addressed with precision medicine.

Dr. Barch asked if thoughts had been given to the practical challenges of getting people to adopt the common data elements. Dr. Heinssen replied that NIMH cosponsored a meeting with SAMHSA, the Robert Wood Johnson Foundation, and a diverse group of providers, researchers, and policymakers, within first-episode health care systems to discuss the feasibility of integrating this type of data collection with routine clinical care. In this context, the goal for common data elements is to achieve a balance between scientific rigor and clinical practicality. Dr. Insel added that the Mental Health Research Network (https://sites.google.com/a/mhresearchnetwork.org/mhrn/), involving 10 million patients, 11 systems, and 12 states, has been instructive about what types of research data can be collected in real-world clinical settings.

Dr. Tamminga said that the real challenge lies in measurement and emphasized the need for biomarkers and fast tests as well as technical solutions to collecting data, such as handheld devices, tablets, and smartphones.

Dr. Hyman said that this is not the best setting to put people through expensive or intensive evaluations, such as imaging and EEGs, but collecting blood for current or future genotyping will be important to assessing severity based on emerging polygene risks.

Dr. Insel said that it may turn out that some of the best predictors of early psychosis outcomes are results from web-based cognitive tests, which can be done anywhere in short amounts of time. Many more people can be recruited for research studies if they are not expected to be involved in complex invasive studies, especially in the context of care.

Dr. Heinssen concluded by saying that recent experiences have demonstrated the value of implementing research-based treatment programs in community clinics in order to address critical public health issues.

Approval of the Concept

Jane Steinberg, Ph.D., asked NAMHC members for a vote on approval of the EPINET concept presentations. The motion to approve the concepts was unanimously passed.

Update on NIH Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Activities

Richard Huganir, Ph.D.
The Johns Hopkins School of Medicine

Greg Farber, Ph.D.
Director, Office of Technology Development and Coordination, NIMH

In introducing Dr. Huganir, Dr. Insel explained that the BRAIN initiative is overseen by a Multi-Council Working Group. A member of the NAMHC, Dr. Huganir, serves on this multi-council working group that involves the 10 institutes that are supporting BRAIN along with FDA, the National Science Foundation (NSF), the Defense Advanced Research Projects Agency (DARPA), and Intelligence Advanced Research Project Agency (IARPA). Dr. Farber, the Director of the NIMH Office of Technology Development and Coordination, supports the activity on the NIMH staff side.

Dr. Huganir said Brain 2025: A Scientific Vision , the report from the BRAIN working group of the ACD, outlines the scientific plan for the Initiative. It proposes that during the first five years, the BRAIN Initiative will emphasize technology development and the creation of neurotechnologies for decoding the language of the brain. The second five years will use these tools for discovery-driven science, with a focus on mapping circuits. The Initiative has become a public and private effort with participation by multiple federal agencies (NIH, DARPA, NSF, FDA, IARPA) and private funding organizations (Howard Hughes Medical Institute, Allen Institute for Brain Science, the Kavli Foundation, and the Simons Foundation).

The goal is to ramp up to $400 million in research funding by FY 2018, and to plateau at $500 million per year by FY 2021. The total investment would be $4.58 billion by FY 2025. In FY 2014, 58 awards were made, many of which were interdisciplinary, totaling $46 million. Awards were made to 100 investigators in 15 states and 3 countries. Funding opportunities in FY 2015 are more limited with only $25 million available in new funds as well as some additional supplemental funds from the NIH Blueprint for Neuroscience.

Some examples of the first Requests for Applications (RFAs) include cell type classification, novel tools, cells, and circuits, ranging from model systems to next-generation human imaging, to large-scale recording and modulation optimization, to integrated approaches to understanding circuit function. New RFAs will focus more on human studies. Going forward, funding is a primary concern, specifically whether new money will be available or whether the BRAIN funds will come out of the R01 pool.

Discussion

Dr. Robinson asked how the partners’ funding is integrated with the federal funding. Dr. Huganir said it is not; there is parallel funding with coordination and interaction among the partners.

Biennial Report of the Inclusion of Women and Minorities in Research

Pamela Collins, M.D., M.P.H.
Director, Office for Research on Disparities & Global Mental Health
Director, Office of Rural Mental Health Research

The NIH Revitalization Act of 1994 mandates that NIH include women and minority group members as participants in clinical research. The goal is to ensure that individuals are included in clinical research in a manner that is appropriate to the scientific question under study. The law also requires that the Advisory Council of each NIH Institute or Center (IC) prepare biennial reports describing how the IC has complied with the law. The Office of Management and Budget (OMB) requires that data be collected and reported on ethnic and racial categories of research participants in the extramural and intramural research programs.

In the NIMH Extramural Research Program, of participants enrolled in NIMH-funded research, females comprised 41.6 percent of clinical research subjects in FY 2013 and 49.1 percent in FY 2014. One reason for the drop in the male proportion is the exclusion of data from the Army Study of Risk and Resilience Among Servicemembers (Army STARRS ) in FY 2014 because funds were not awarded in that year. In both FYs, a majority of participants identified as White (56 percent in FY 2013 and 53.5 percent in FY 2014). The largest racial minority groups were African American (23 percent in FY 2013 and 25 percent in FY 2014), followed by Asian American (9 percent in FY 2013 and 10 percent in FY 2014). There were some small decreases in the percentages of participants identifying as American Indian and Alaska Native (1 percent to .7 percent), Hawaiian and Pacific Islander (.4 percent to .3 percent), and more than one race (3.3 percent to 2.9 percent) over these two years.

The percentage of Hispanic participants decreased from 11 percent in FY 2013 to 9 percent in FY 2014, again in part due to the discontinuation of reporting for Army STARRS.

In both FY 2013 and 2014, about 23,000 participants were enrolled in NIMH extramural phase III clinical trials; however, the vast majority of these participants, 22,000, were enrolled in a National Cancer Institute (NCI) study, co-funded by NIMH, that was examining the effects of vitamin D and Omega-3 fatty acids on cancer, heart disease, and stroke. NIMH supplemented this study to be able to look at vitamin D in depression and other disorders. In both FY 2013 and 2014 about 53 percent of these participants were female and 47 percent were male. Excluding the NCI study data drops the number of participants in phase III clinical trials significantly to 448 in FY 2013 and 622 in FY 2014, with the percentage of women dropping from 60.5 percent in FY 2013 to 49.1 percent in FY 2014.

Among this distribution of participants, the majority reports their race as white and the largest racial minority group is African American at 11.6 percent in FY 2013 and increasing to 17 percent in FY 2014. Similarly, the data on ethnicity within the larger NCI trial showed Hispanics comprising nearly equivalent numbers in FY 2013 and FY 2014 (6.3 percent and 6.4 percent). When the larger trial data are excluded the number of Hispanic participants was 10.7 percent in FY 2013 and 11.7 percent in FY 2014.

With regard to combined NIMH intramural research, the percentages remained the same from FY 2013 to FY 2014, at 53 percent females and 47 percent males. The racial distribution was similar in FY 2013 and FY 2014, with the majority of participants identifying as White and the largest racial group identifying as Black or African American, followed by Asian American at 5 percent, American Indian and Alaska Native at 0.2 percent, and Hawaiian and Pacific Islanders at 0.1 percent. Two percent of participants identified as more than one race. The majority of participants are non-Hispanic; roughly 5 percent of the participants identify as Hispanic in both years. The Clinical Center is continuing its outreach to Hispanic communities in order to increase enrollment by contacting local agencies and providers that work for Hispanic communities.

Discussion

Dr. Areán asked if participants were identifying as African American and also Hispanic. Dr. Collins said those numbers could be ascertained.

Dr. Rotheram asked for clarification of the data from each program and asked if similar data were available on investigators. Dr. Collins did not have those data available, but noted they are collected periodically. However, such data include personal identifying information (and, thus, must be requested centrally from NIH).

Dr. Insel noted that there has been a profound dropout of women among job applicants, despite parity in the number of degrees being awarded, and asked if others have experienced the same. Moreover, while NIH is trying to diversify the scientific workforce, there are fewer minority candidates applying. Council members expressed some similar experiences, citing the issue of “work/life balance” as one reason they are hearing hesitancy among female applicants. Dr. Tamminga said she is seeing a generational change on this issue. Dr. Barch suggested that the tough funding environment might disproportionately affect young investigators, particularly women.

Dr. Linehan asked whether data could be collected on gender identity. Dr. Collins replied that currently NIMH does not have a specific category for transgender, but does have the option of allowing people to change their designated identity over the course of a study.

Dr. Carpenter added that one of the purposes of collecting these data is to ensure the health issues of everyone are being addressed. In addition, it is important to recognize there might be a difference between biological identity and how someone self-identifies.

Dr. Collins agreed that the purpose of collecting these data is to ensure that we have adequate inclusion of everyone, with the ultimate goal of conducting research that is relevant to the public's health. The law states that individuals have the right to self-identify their race and ethnicity. Dr. Hyman added that there is a lot of complexity in how people identify, the significance of their genomic data, and how we might target treatments and pursue personalized medicine. More complexity could surround psychosocial treatments. He urged the group to not get too far ahead and make assumptions about the biology of the complex and diverse group of individuals who are transgender.

Dr. Tamminga asked if there are resources to help facilitate recruitment of Hispanics into trials. Dr. Collins said appropriate materials are available on the NIMH website.

Dr. Barch asked about the ability to further stratify population samples. Dr. Collins responded that there are initiatives to encourage subgroup analyses and recruitment of those groups needed to obtain valid analyses which are useful in terms of looking at outcomes.

Dr. Insel noted that there has been a real reduction in the size of Phase III clinical trials and more focus is needed on ensuring that studies are appropriately powered.

Approval of the Report

Dr. Steinberg asked NAMHC members for a vote on approval of the Biennial Report of the Inclusion of Women and Minorities in NIMH Research. The motion to approve the report was unanimously passed.

Update on Council Activities

NAMHC FAST Working Group

Jill Heemskerk, Ph.D.
Deputy Director, Division of Translational Research
FAST Council Working Group

FAST is a contract initiative that aims to test hypotheses about the mechanisms of mental health disorders, using an experimental medicine approach to clinical trials. This approach requires: 1) a molecular target implicated in the disorder; 2) a target-selective, CNS-penetrant compound; and 3) a target-specific measure of brain function to monitor target engagement. These clinical trials would determine a dose that adequately engages the target and look for correlations between target engagement and clinical outcomes. This approach has the advantage of being informative regardless of whether the outcome is positive or negative. In contrast to a straightforward efficacy study, the experimental medicine approach tells you whether target is relevant to the clinical problem, thereby eliminating those that will not be productive to pursue.

Three experimental medicine contracts are in place: 1) FAST-MAS for mood and anxiety spectrum at Duke University; 2) FAST-PS for psychotic spectrum at Columbia University; and 3) FAST-AS for autism spectrum at University of California, Los Angeles. Three trials are underway: 1) GABA-A a2/a3 selective positive modulator for adult ASD, with a pediatric follow on study planned; 2) opioid antagonist for anhedonia; and 3) biomarker development for a) detecting changes in glutamate levels and b) changes in mGluR5 expression.

Key needs for accelerating trials include: use of a central IRB, standard partnership agreements, contracts mechanisms, and project management. The biggest scientific bottleneck is the lack of biomarkers to test hypotheses and as a go/no go tool for testing drug candidates. Thus, much of the initial effort under the contracts focuses on development of new biomarkers that will be broadly useful to the field. Importantly, FAST is exceeding expectations in getting access to very promising industry compounds. Active pipeline compounds have been proposed by five pharmaceutical companies.

Industry is interested in partnering with the FAST program because of the trials expertise of the contractors in mental health indications. This is especially attractive to companies that have been scaling back their internal psychiatry and other central nervous system development programs. The FAST efforts create networks industry can plug into to have their own compounds rigorously and efficiently tested. The experimental medicine design is attractive because this strategy is becoming industry standard as an approach for clinical development of compounds. Industry is also intrigued by the RDoC focus. There is also growing appreciation for access to patients at academic sites versus contract research organizations where there are often “professional patients” in the mix that add “noise” that may obscure results.

Discussion

Dr. Hyman emphasized the value of this approach, as it avoids large, lengthy, and expensive trials that are unsuccessful and might be duplicated because a company does not realize the target has been invalidated. He asserted the importance of keeping engaged the small number of companies still interested in mental disorders.

BD2K: Where Have We Been and Where Are We Going?

Gene Robinson, Ph.D.
University of Illinois at Urbana-Champaign
Big Data to Knowledge (BD2K) Multi-Council Working Group

Big Data to Knowledge (BD2K) is a trans-NIH initiative because big data is a common challenge. All NIH ICs review and provide input on BD2K Funding Opportunity Announcements (FOAs) to ensure consistent and comparable consideration and to promote cohesion of the overall BD2K consortium. Currently there are 11 BD2K Centers of Excellence funded in the range of $9-12 million and focused on imaging, genomic data, data handling and storage, censor data, and data extraction. The centers are expected to work together to share data and develop common platforms and software.

A number of FOAs are in effect for FY 2015. Standardization of big data is a central focus, involving engineering, mathematics, statistics, and computer science. Other programs focus on training through Workforce Coordination Centers, policy related to privacy and control of data, and access to data. In FY 2015, there will be greater efforts to reach out to other federal funding agencies on shared big data issues, such as the National Science Foundation, the National Oceanic and Atmospheric Administration, other HHS agencies, and the EU. Public-private partnerships are being considered as well.

Dr. Robinson described the organizational structure of the Multi-Council Working Group and how it interacts with the NIH ICs. In the future, the Common Fund contribution to BD2K will decrease as the IC contributions increase.

Discussion

Dr. Hyman commented on data security issues in the cloud and asked how BD2K was resolving security issues recognizing that regulations can make it difficult to bring data sets together. Dr. Robinson responded that he would ask the centers to respond to this question.

Dr. Insel asked Dr. Rotheram to report on the Council of Council’s work on AIDS research funding across NIH. She replied that a report is anticipated soon.

Mr. Heimer was asked to report on his recent participation in the Council of Councils. He mentioned upcoming funds available for pediatric research through the Gabriella Miller Kids First Act. Dr. Insel added that the Act provides $12.6 million a year for 10 years. Additional funds will be available from the Nationals Children’s Study ($165 million), which has been discontinued. Some of those funds will be used to fund the Vanguard Study; others will be spent on environmental pediatrics, particularly environmental influences on development, with environment broadly defined. NIH is still determining how to spend the one-year allocation.

NIMH Strategic Plan for Research

Thomas R. Insel, M.D.

Dr. Insel noted that the Council has discussed the update of the NIMH Strategic Plan during its previous meetings on several occasions. He reminded members that the prior Strategic Plan was developed in 2008. With Council’s agreement, NIMH decided to update the 2008 plan to better align with the current scientific environment. The document revises the 2008 plan more than initially expected. NIMH shared a draft with the Council in September 2014 and posted it for public comment in October 2014. Nearly 600 comments were received. Under the leadership of Kevin Quinn, Ph.D., Acting Director of the Office of Science Policy, Planning and Communications, the comments were reviewed and the plan further revised. Strategic Research Priorities for each Strategic Objective are being prepared in parallel.

Dr. Insel summarized the feedback received from Council in September 2014 and NIMH’s response. Some Council members felt that training and communication were not adequately covered. The title has been changed to the NIMH Strategic Plan for Research to clarify the scope of the Plan. A second comment focused on environmental factors (social and cultural), which were not adequately covered before. New language has been added about mental health disparities. Clarifying language was added pertaining to targets and Research Domain Criteria (RDoC).

Strategic Objective 1: Define the Mechanisms of Complex Behaviors, was cast more broadly to include mechanisms however they might play out.

Strategic Objective 2: Chart Mental Illness Trajectories to Determine When, Where, and How to Intervene, was revised to clarify that development across the lifespan was the intent.

Strategic Objective 3: Strive for Prevention and Cures, was revised to be more targeted.

Strategic Objective 4: Strengthen the Public Health Impact of NIMH-supported Research, retained its long list of goals in response to positive feedback.

The Plan will be released in March and the Strategic Research Priorities will be posted on the NIMH website at the same time.

Discussion

Dr. Sweatt asked whether there are metrics for measuring success. Dr. Insel responded that the Division of Services and Interventions Research is leading an effort with SAMHSA to create a dashboard of measures of prevalence, morbidity, and mortality. NIMH wants to move away from thinking about outcomes in terms of papers published and grants funded, but rather in terms of public health outcomes.

Dr. Areán expressed concern that people over the age of 65 are underrepresented in terms of mental health services and in research. Dr. Insel agreed and said consideration of this population will be added to the Plan.

Dr. Linehan expressed appreciation for increased attention to behavior in the plan and urged that the term “behavior” sometimes be introduced first before the term “biology.” She recommended that NIMH not use the phrase “brain disorders.”

Dr. Hyman commented that the focus on impact of NIMH research on public health requires that studies are powered and designed in a way to be convincing. Dr. Insel replied that NIMH has been doing fewer large studies, but questioned whether approach is reasonable given that it is often the large investments that give us the biggest impact. Dr. Hogan said that the RAISE study was a good example of this strategy. Dr. Linehan added that there has to be a way to conduct proof-of-principle studies before launching a large-scale effort.

Dr. Sweatt asked how NIMH can get early stage scientists involved in doing larger studies. Dr. Barch said that there is a need to think about economies of scale that would allow for several studies to be conducted within the context of large scale studies. This would provide the power needed for the study to be convincing, while allowing for creativity and a role for early stage scientists.

Dr. Oquendo noted that there is an opportunity in Strategic Objective 4 to integrate the new initiative with Global Mental Health, reminding people that that such work need not be conducted internationally. There are good opportunities in this country to do that kind of work. Dr. Insel agreed that the Plan could be revised to clarify this issue.

Dr. Hogan praised the Plan and noted its overall strengths. He also encouraged greater consideration of the public health burden attributable to loss of potential because of inadequate and harmful environments for young children. In addition, the Affordable Care Act’s requirements regarding fiscal and management responsibility for the health system will require that we look broadly at how changes in the delivery system are affecting health.

Dr. Tamminga noted that the revised objectives are easier to understand and more engaging. She asked whether the Plan should address mental health issues in the incarcerated population. Dr. Insel responded that Strategic Objective 4 does address the criminal justice system.

Dr. Katz said that the Department of Veterans Affairs views mental health within an overall health care system. An important issue is patients with mental health conditions who are viewed as a minority group subject to health care disparities. Dr. Insel said that the National Institute on Minority Health and Health Disparities has found that people with mental illness actually exceed many of the groups we typically think about in terms of health disparities.

Dr. Carpenter asked if it is possible to allow individual sites in large multi-site studies to collect their own additional data of interest to them. Dr. Insel said that NIMH is increasingly trying to use supplements to leverage opportunities for these types of add-ons, which would complement the common data elements being collected.

Public Comment

Dr. Insel invited members of the audience to make any comments to the Council.

William Carpenter commented that there are limited empirical data available to guide pharmacotherapy in late-life schizophrenia. He said there is also a need to better translate environmental risk factor data into primary prevention of mental disorders.

In closing, Dr. Insel thanked all who participated in the meeting. He recessed the open session meeting at approximately 2:30 p.m.

Thomas R. Insel, M.D.

Appendix A

Summary of Primary MH Applications Reviewed

February 2015

Category	IRG Recommendation
	Scored #	Scored Direct Cost $	Not Scored (NRFC) #	Not Scored (NRFC) Direct Cost $	Other #	Other Direct Cost $	Total #	Total Direct Cost $
Research	536	$660,319,150.00	376	$421,124,630.00	8	$1,366,609.00	920	$1,082,810,389.00
Research Training	26	$47,915,136.00	11	$16,269,180.00	0	$0.00	37	$64,184,316.00
Career	52	$35,607,164.00	23	$16,164,945.00	0	$0.00	75	$51,772,109.00
Other	1	$0.00	0	$0.00	0	$0.00	1	$0.00
Totals	615	$743,841,450.00	410	$453,558,755.00	8	$1,366,609.00	1033	$1,198,766,814.00

Appendix B

Department of Health and Human Services
National Institutes of Health
National Institute of Mental Health
National Advisory Mental Health Council

(Terms end 9/30 of designated year)

Chairperson

• Thomas R. Insel, M.D.
  Director
  National Institute of Mental Health
  Bethesda, MD

Executive Secretary

• Jane A. Steinberg, Ph.D.
  Director
  Division of Extramural Activities
  National Institute of Mental Health
  Bethesda, MD

Members

• Patricia A. Areán, Ph.D. (16)
  Professor
  Director of Targeted Treatment Development
  University of Washington
  Department of Psychiatry and Behavioral Sciences
  Seattle, WA
• Deanna M. Barch, Ph.D. (16)
  Gregory B. Couch Professor of Psychiatry
  Department of Psychology, Psychiatry and Radiology
  Washington University
  St. Louis, MO
• David A. Brent, M.D. (17)
  Academic Chief
  Child & Adolescent Psychiatry
  Endowed Chair in Suicide Studies
  Professor of Psychiatry, Pediatrics and Epidemiology
  Director, Services for Teens at Risk
  University of Pittsburgh School of Medicine
  Pittsburgh, PA
• Randall L. Carpenter, M.D. (15)
  Co-Founder, President and Chief Executive Officer
  Seaside Therapeutics
  Cambridge, MA
• BJ Casey, Ph.D. (16)
  Sackler Professor
  Department of Psychiatry and Neuroscience
  Sackler Institute for Developmental Psychobiology
  Weill Medical College of Cornell University
  New York, NY
• Benjamin G. Druss, M.D., M.P.H. (18)
  Rosalynn Carter Chair in Mental Health and Professor
  Department of Health Policy and Management
  Rollins School of Public Health
  Emory University
  Atlanta, GA
• Lisa Greenman, J.D. (15)
  Attorney
  Federal Death Penalty Resource Counsel Project
  Washington, DC
• Hakon Heimer, M.S. (16)
  Founding Editor
  Schizophrenia Research Forum
  Brain and Behavior Research Foundation
  Providence, RI
• Michael F. Hogan, Ph.D. (18)
  Consultant and Advisor
  Hogan Health Solutions LLC
  Delmar, NY
• Richard L. Huganir, Ph.D. (17)
  Professor and Director
  Department of Neuroscience
  Investigator, Howard Hughes Medical Institute
  Co-Director, Brain Science Institute
  The Johns Hopkins University School of Medicine
  Baltimore, MD
• Steven E. Hyman, M.D. (15)
  Director, Stanley Center for Psychiatric Research
  Broad Institute
  Cambridge, MA
• Marsha M. Linehan, Ph.D. (17)
  Professor and Director
  Behavioral Research and Therapy Clinics
  Department of Psychology
  University of Washington
  Seattle, WA
• Maria A. Oquendo, M.D. (17)
  Vice Chair for Education
  Professor of Psychiatry
  Department of Psychiatry
  Columbia University
  New York State Psychiatric Institute
  New York, NY
• Gene E. Robinson, Ph.D. (16)
  Director, Institute for Genomic Biology
  Swanlund Chair
  Center for Advanced Study Professor in Entomology And Neuroscience
  University of Illinois at Urbana-Champaign
  Urbana, IL
• Mary Jane Rotheram, Ph.D. (16)
  Bat-Yaacov Professor of Child Psychiatry And Behavioral Sciences
  Director, Global Center for Children and Families
  Director, Center for HIV Identification Prevention And Treatment Services (CHIPTS)
  Semel Institute and the Department of Psychiatry, University of California, Los Angeles
  Los Angeles, CA
• J. David Sweatt, Ph.D. (16)
  Professor
  Evelyn F. McKnight Endowed Chair
  Department of Neurobiology
  Director, McKnight Brain Institute
  University of Alabama at Birmingham
  Birmingham, AL
• Carol A. Tamminga, M.D. (15)
  Professor and Chair
  Department of Psychiatry
  University of Texas
  Southwestern Medical Center
  Dallas, TX
• Hyong Un, M.D. (17)
  Head of EAP & Chief Psychiatric Officer
  AETNA
  Blue Bell, PA

Ex Officio Members

Office of the Secretary, DHHS

• Sylvia M. Burwell
  Secretary
  Department of Health and Human Services
  Washington, DC

National Institutes of Health

• Francis Collins, M.D., Ph.D.
  Director
  National Institutes of Health
  Bethesda, MD

Veterans Affairs

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

Department of Defense

• John W. Davison, M.B.A., Ph.D.
  Director, Behavioral Medicine Division
  Office of the Chief Medical Officer (OCMO)
  TRICARE Management Activity, OASD (HA)
  Falls Church, VA

Liaison Representative

• Paolo del Vecchio, M.S.W.
  Director
  Center for Mental Health Services
  Rockville, MD