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Transforming the understanding
and treatment of mental illnesses.

NAMHC Minutes of the 255th Meeting

January 31, 2019

Department of Health and Human Services
Public Health Service
National Institutes of Health
National Advisory Mental Health Council

Introduction

The National Advisory Mental Health Council (NAMHC) held its 255th meeting at 9:15 am, January 31, 2019 at the Neuroscience Center in Rockville, Maryland. In accordance with Public Law 92-463, the session was open to the public until 1:00 pm, and closed thereafter from 2:00 pm for consideration of grant applications. Joshua Gordon, M.D., Ph.D., Director of the National Institute of Mental Health (NIMH), presided as Chair.

Council Members

(Appendix B, Council Roster )

Chairperson

Joshua Gordon, M.D., Ph.D.

Executive Secretary

Jean Noronha, Ph.D.

Council Members Present

  • Rhonda Robinson Beale, M.D.
  • Tami Benton, M.D.
  • Randy Blakely, Ph.D.
  • Benjamin Druss, M.D., M.P.H.
  • Ian Gotlib, Ph.D.
  • Alan Greenberg, M.D., M.P.H.
  • David Henderson, M.D.
  • Michael Hogan, Ph.D.
  • Lisa Jaycox, Ph.D.
  • Cheryl King, Ph.D.
  • John Krystal, M.D.
  • Gregory Miller, Ph.D.
  • Neil Risch, Ph.D.
  • Rhonda Robertson Beale, M.D.
  • Elyn Saks, Ph.D.
  • Brandon Staglin, M.S.
  • Christopher Walsh, M.D., Ph.D.

Department of Veteran Affairs

  • Amy Kilbourne, M.D., Ph.D.

Department of Defense

  • Steven Pflanz, M.D.

Liaison Representative

  • Anita Everett, M.D.

Ad Hoc Members Present

  • Laura Almasy, Ph.D.
  • Marjorie Baldwin, Ph.D.
  • Sophia Vinogradov, M.D

Others Present at the Open Policy Session

  • Susan Amara, NIMH Intramural Program
  • David Van Essen, BSC
  • Andre Fenton, BSC
  • Margaret McCarthy, Board of Scientific Counselors (BSC)
  • Elle Mooby, BSC
  • Patricia O’Donnell, BSC
  • Tania Pasternak, BSC
  • Diana Bianchi, Presenter
  • Erin Cadwalader, Lewis-Burke Associates
  • Jobes Conner, American Foundation for Suicide
  • Kurt DeSoto, Association for Psychological Science
  • Denise Doughtery, Academy Health
  • Jonelle Duke, Bizzell Group
  • Diana Feiner, Tourette Association of America
  • Craig Fisher, American Psychological Association
  • Matthew Goldman, SAMHSA
  • John Karvatas, Transcriber
  • Maria Rowland, Science Writer
  • Eric Scharf, Depression and Bipolar Support Alliance
  • Andrew Sperling, National Alliance on Mental Illness
  • A.J. Walker, National Association of State Mental Health Program Directors
  • TaRaena Yates, Bizzell Group

Open Policy Session Call to Order & Opening Remarks

Joshua Gordon, M.D., Ph.D.

NIMH Director, Dr. Joshua Gordon, opened the NAMHC meeting by welcoming Current and Ad Hoc Council Members, and the public. Following introductions, the Council unanimously passed a motion approving the final Summary Minutes of the September 20, 2018 meeting

NIMH Director’s Report

Joshua Gordon, M.D., Ph.D.

Federal Updates and Constituent Relations

Dr. Gordon briefly updated participants and attendees on recent NIMH congressional interactions. He described his recent site visit and grand rounds at the Department of Psychiatry at State University of New York Upstate Medical Center, which he attended with Representative John Katko (R-NY). He also spoke about his participation in the Louisiana State Mental Health Summit in Baton Rouge with Senator Bill Cassidy (R-LA), where he learned that recent Medicaid expansions in the state have dramatically improved access to care for many Louisianans. Dr. Gordon then summarized his recent briefing with Representative Gary Palmer (R-LA) and their discussions on the use of psychotropic medications in youth and on violence in schools. He added that various NIMH staff members have also participated in briefings for congressional leaders and their staff.

Dr. Gordon reviewed the annual meeting of the NIMH Alliance for Research Progress, which was held in October 2018. They discussed psychosis in at-risk youths, treatment strategies for ADHD, cognitive neuroscience for neuropsychiatric symptoms, and evaluation of the Zero Suicide initiative in real-world settings. They also discussed legislative activities, such as the Support Act, have addressed the ongoing opioid crisis. Lastly, Dr. Gordon mentioned collaborating with an interagency task force on trauma-informed care. He reiterated that NIH’s role in this collaboration is to ensure that the most recent evidence-based practices are taken into consideration.

NIMH Budget

Dr. Gordon reviewed the budget for Fiscal Year (FY) 2019. NIH received $39.1 billion, representing a $2B increase from FY 2018. NIMH saw a 2 percent overall budget increase and received $1.8B. The NIH budget has increased $10B over four consecutive years, and Congress has added about half of these funds to the Brain Initiative. Dr. Gordon noted that this increase has allowed NIMH to begin funding additional meritorious grants ranked in the 20th to 30th percentiles, rather than limiting funds to grants in the top 10th to 15th percentiles. However, he acknowledged that NIMH can still only fund about one-fifth of all grant applications received.

Priorities

Because the strategic plan is up for renewal in 2020, Dr. Gordon said that efforts to revise the NIMH Strategic Plan for Research are already underway. He indicated that these revisions began with changes to the strategic research priorities, which detail specific areas of the plan to guide investigators. He expressed hope that drafts of the revisions will be available to the council for review by summer 2019.

Dr. Gordon explained that NIMH has made structural changes to align with emerging priorities, including changing the structure of global mental health efforts. The Office for Research on Disparities and Global Mental Health was split into the Center for Global Mental Health Research and the Office of Disparities Research and Workforce Diversity. The Center for Global Mental Health Research was integrated into the Division of AIDS Research.

Dr. Gordon highlighted two recent NIMH guide notices for applicants about the NIMH priorities in genomics and stress biology research. He indicated that NIMH is working on similar guidance for research with animal models.

Dr. Gordon stated that NIMH also updates priorities by coordinating with other federal agencies. He reviewed NIMH interactions with the Interagency Autism Coordinating Committee and said that outcomes of the IACC have included increasing our research focus on adults and transition-aged youth with autism.

Leadership News and Awards

Several NIMH staff members have received recognition in recent months, including: Ellen Leibenluft, M.D. (elected to the National Academy of Medicine and first female recipient of the American College of Neuropsychopharmacology (ACNP) Julius Axelrod Mentorship Award); Barbara Lipska, Ph.D. (recipient of the ACNP 2018 Media Award); and Jane Pearson, Ph.D. (recipient of the American Psychological Association Meritorious Research Service Commendation for Leadership). Additionally, NIH recently welcomed Bruce Tromberg, Ph.D., as the new Director of the National Institute of Biomedical Imaging and Bioengineering.

Dr. Gordon also took a moment to remember two NIH members who recently passed away: Steven Katz, M.D., Ph.D., Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and Lewis Judd, M.D., former Director of the NIMH.

NIH-Wide Initiatives

Motivated by recent reports of research misconduct, NIH is aiming to protect the integrity of the biomedical research enterprise in the United States. The NIH has also announced and disseminated a new anti-harassment policy after a National Academies of Sciences, Engineering and Medicine report on harassment in the biomedical community.

Dr. Gordon also reviewed a number of new NIH-wide scientific initiatives. He gave an update on the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative, which is now fully funded at $420 million for FY 2019. These appropriations have resulted in 200 new awards in 2018, to more than 100 research institutions and more than 500 investigators. BRAIN Initiative Neuroethics awardees have recently published two commentaries in the General Bureau of Science and other journals, and there are ongoing efforts to formally re-evaluate the 2025 strategic plan.

Congressional appropriations have enabled the development of the Helping to End Addiction Long-term (HEAL) Initiative, which encompasses more than 35 funding opportunity announcements in two broad areas: the development of non-opiate pain medications and treatments for opiate use disorders. Dr. Gordon also mentioned the Adolescent Brain Cognitive Development (ABCD) Study. More than 12,000 children have been recruited in ABCD, and the first data sets and papers have already been released. Lastly, Dr. Gordon touched on the All of Us Research Program, an ongoing effort to develop whole-genome sequencing on 1 million Americans.

Science Highlights

Dr. Gordon closed his update by briefly highlighting new findings supported by the Division of AIDS Research. He discussed a publication by Farhadian, et al., focused on high throughput single cell RNA sequencing to characterize the immune landscape in the cerebrospinal fluid of virally suppressed HIV infected patients. Additionally, he also described research supported by the Division of Services and Intervention Research on the extent to which early intervention can normalize trajectories of brain development in at-risk children from early adverse experiences on the developing brain. Bick, et al. carried out longitudinal studies using EEG measurements to develop early interventions for psychiatric illnesses in children. Dr. Gordon cautioned that these intervention studies are still in early, broad stages, but he pointed out that the findings are valuable nonetheless. Finally, he reviewed research by Li, et al. related to PsychENCODE, a program that collects post-mortem brain tissue samples for use in genetic and neuroscientific research.

Discussion

Dr. Gotlib asked if the Bick, et al. paper made any reference to behavioral mechanisms in the sample population. Dr. Gordon responded that the paper primarily described the EEG results, and that he did not know the behavioral measures used. Dr. Joel Sherrill responded that the investigators used measures of self-regulation and cognitive function.

Dr. King inquired about the timeline and short-term objectives of the All of Us Research Program. Dr. Gordon responded that the initiative already has approximately 200,000 participants, and the goal is 500,000 within the next two years. He said that the general public and the participants receive pre-publication access to the data. Participants get access to their own individual data which is new for NIH and the ethical issues around this are being worked out. Dr. Gordon highlighted NIMH’s component of All of Us, which involves evaluation of psychiatric symptomatology as part of the basic clinical evaluations and the development of a set of behavioral assessments that will allow us to test a lot of hypotheses about Research Domain Criteria (RDoC) and also link that or compare that to DSM diagnoses. Dr. Henderson wondered if the All of Us Program will collaborate with other large-scale projects and the possibility of neuroimaging data on a subset of All of Us participants. Dr. Gordon pointed out that the program is already in discussions with the U.K. Biobank. He indicated that the NIH does not yet know about prospects for large-scale neuroimaging. Additionally, the intention for All of Us is to prioritize funding for behavioral assessment initiatives before tackling cost-intensive neuroimaging projects.

Dr. Vinogradov expressed excitement about the new initiatives and highlights related to development and interventions, and she wondered if NIH has given any thought to ensuring that these different initiatives are appropriately integrated. Dr. Gordon explained that there are ongoing efforts to harmonize data acquisition across these projects. For example, they plan to partially integrate ABCD and the Heal Initiative to study cohorts beginning from prenatal through 10 years old.

Dr. Kilbourne asked if the All of Us Program results would be made immediately available to providers. Dr. Gordon directed individuals to the All of Us website for specific details.

Mr. Staglin asked if the HEAL Initiative has explored preventive interventions to help young people preemptively avoid substance addiction. Dr. Gordon replied that there are currently at least three Requests For Applications focused on developing preventative strategies. Dr. Reider commented that there is a NIDA-led initiative to prevent opioid use disorders in youth aged 16 to 30 years.

An Investigator’s Journey from Phenomenology to Treatment to Implementation

Progress and Pitfalls in Advancing Public Health in Depression

Joan Luby, Ph.D.

Dr. Luby began her presentation by underscoring the need for acceleration in the progress of mental health treatments and early identification of mental health disorders. She told the Council that to achieve these goals, it is necessary to facilitate treatment work among investigators. Currently, investigators struggle to secure funding for treatment research, ultimately contributing to a progress lag in the mental health field.

She gave an historical overview of her career experiences as an investigator and her early work on depression in preschoolers, which found that early environment profoundly influences brain development, specifically hippocampal volume, through childhood into early adolescence. Notably, her research found that early maternal support positively impacts hippocampal development, improving outcomes for emotional regulation and functional adaptiveness.

Dr. Luby then ventured into depression treatment research. Informed by Sheila Eyberg’s Parent-Child Interaction Therapy (PCIT), she designed the Emotional Development module, a therapeutic intervention that approaches childhood depression as a disorder of emotional development. The model uses the parent as a coach and external regulator to help children learn adaptive strategies for emotional regulation, in addition to techniques for self-soothing and sustained positivity. The intervention had significant positive effects, which Dr. Luby attributed to childhood neuroplasticity.

However, Dr. Luby explained that she initially faced immense barriers to implementing her new treatment intervention. She expressed frustration that innovative treatments are often blocked by insurance providers and research funding restrictions, and she suggested that the lack of public spending on children and families in the United States constitutes a public health emergency. After struggling to secure funding to deliver the intervention, Dr. Luby received funding from the Children’s Hospital in St. Louis. Currently, she is using these funds to implement the Jennings School Project, an initiative to train therapists to deliver the Emotional Developmental module in school.

Discussion

Dr. Robinson Beale explained her perspective on insurance for innovative treatments, pointing out that providers require consistent results from replicable studies to justify spending public funds on new intervention. She added that funding from foundations is the best option for investigators seeking to deliver treatments.

Mr. Staglin wondered if there is a connection between early life depression and eventual development of more severe psychiatric conditions, such as schizophrenia, and he asked if Dr. Luby is working to develop any interventions to prevent psychosis later in life. Dr. Luby suggested that schizophrenia and depression may have separate risk trajectories.

Dr. Kilbourne returned to Dr. Robinson Beale’s point about insurance, explaining that there are barriers to providing mental health services in schools because billing often requires that services are provided in clinical settings.

Dr. Benton expressed appreciation that Dr. Luby’s research focuses on prevention. She noted that in her own work, she has found that payers are often willing to offer enhanced rates when investigators are able to demonstrate evidence-based change, and she suggested that investigators should be more assertive in approaching these kinds of collaborations. Dr. Luby replied that she hopes to use this approach in Missouri.

Dr. Greenberg asked if NIMH has a clinical trial infrastructure comparable to the Division of AIDS Research, where individual investigators use centralized networks for data management, statistics, and clinical research sites. Dr. Gordon responded that these structures generally are not in place in the mental health field. He then asked Dr. Sherrill to comment about existing funding opportunities.

Dr. Sherrill said that there have been efforts to refine available funding mechanisms for intervention development, treatment research, and prevention research. He explained that the R61 and R33 approach allows isolated assessment of clinical trials for psychosocial intervention research. The review staff appreciate the complexities and challenges of intervention development and testing, and they are interested in working with applicants to match funding mechanisms to their priorities. Dr. Gordon added that an increase in costs associated with clinical research has decreased the number of trials that can receive funding.

Dr. Baldwin drew on her experience as an economist, pointing out that returns on investments are highest in early childhood. Over time, this leads to reduced health care costs and the burdens of behavioral and disciplinary problems. She added that Dr. Luby could make this case to Medicaid officials because the Jennings School Project involves an impoverished population.

The Many Opportunities for Enhanced Partnerships Between NIMH and NICHD

Dianne Bianchi, M.D.

Dr. Bianchi began her presentation by clarifying that the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), of which she is Director, does not limit its scope to children. In fact, 50% of their total budget is funded toward child health research, while other 30% and 18% of funds go to reproductive health and intellectual and physical disabilities, respectively. She pointed out that all federal health agencies support pediatric research and that 25% of the NIMH budget is coded for child health. As a result, there is opportunity for interagency collaborations related to child health.

Dr. Bianchi summarized a number of existing initiatives to motivate partnerships between NICHD and other institutes. Last year, NICHD formed the Trans-NIH Pediatric Research Consortium (NPERC) with the goal of harmonizing efforts in child health research across 27 institutes and centers. NPERC is working to create a federation of resources for pediatric research, including training support and data integration. The organization is also involved in outreach to senior pediatric researchers to provide their expertise on review panels. Dr. Bianchi also briefly summarized intramural collaborations at NICHD.

Most collaborations at NICHD focus on large projects, and direct co-funding is relatively small. Dr. Bianchi told the Council that NICHD has funded $7.2M of NMIH grants, while NIMH has funded $3.9M of NICHD grants. Dr. Bianchi mentioned that the two organizations recently co-funded a workshop on rare genetic diseases, and both are working to co-support the resultant Funding Opportunity Announcement.

Dr. Bianchi reviewed the INCLUDE Project as an example of a successful trans-NIH initiative, which brings together 18 institutes and centers. The program, which supports research related to Down syndrome and co-occurring conditions, has three goals: to conduct targeted studies on chromosome 21, to assemble large cohorts of people with Down syndrome, and to add people who have Down syndrome to existing clinical trials.

She then shifted focus to the NICHD strategic planning process, which aims to identify scientific priority areas in which NICHD can lead at NIH. The plan will also identify potential partnerships and align funding with new priorities. She explained that NICHD examined their entire $1.5B portfolio and discovered that a significant proportion of the research they funded has informed high-impact publications. Collaboration between NICHD council members and external working group yielded 272 potential scientific themes, which was then narrowed to 6. These included: 1) understanding early human development, 2) promoting healthy pregnancy, 3) promoting gynecological and reproductive health, 4) identifying sensitive time periods, 5) improving health in transition-aged populations, and 6) ensuring safe and effective therapeutics and devices.

Dr. Bianchi briefly reviewed the PRGLAC Task Force, which was tasked as a part of the 21st Century Cures Act, to make recommendations about the status of medications taken by pregnant and lactating women. Of the 6.3 million women who become pregnant annually in the United States, more than 90 percent take at least one medication during pregnancy. The Task Force made 15 recommendations related to this issue, many of which related to supporting research, expanding obstetrics expertise, and removing outdated regulatory barriers. The resultant 400-page report has been incorporated into the upcoming NICHD strategic plan, which will be finalized by the end of FY 2019.

She concluded by reiterating that NICHD does not exclusively fund pediatric research, and that NICHD and NIMH are partnering in the child health arena. Significant collaborative efforts are already in place, but there are plentiful opportunities to expand these partnerships

Discussion

Dr. Everett suggested that NICHD priorities related to childhood trauma be expanded to consider social determinants or adverse childhood events. Dr. Bianchi said that NICHD already funds extensive research related to adverse social events as a trauma-associated factor. Dr. Everett added that marijuana use among pregnant women is another potential area for concern. Dr. Bianchi agreed, adding that NICHD is working on a cognitive development program, which will address the issue of drug use during pregnancy.

Dr. Hogan pointed out that children’s hospitals in the United States have become the primary engine of positive change for children’s futures, and he wondered if NICHD is taking any action to shape and capitalize on this energy. Dr. Bianchi responded that children’s hospitals are focused both on typical development and on disease, which may involve other institutes. She mentioned that NICHD has invested $80M in the Human Placenta Project, which aims to noninvasively determine the health of the placenta during pregnancy.

Dr. Luby expressed the opinion that children’s hospitals tend to marginalize mental health issues, which clogs the pipeline for interventions.

Triennial Report of the Inclusion of Women and Minorities in NIMH Research

Ashley Kennedy, Ph.D.

Dr. Kennedy began her presentation by explaining that NIH is mandated to ensure the inclusion of women and minorities in clinical research. The NIH Inclusion Policy is designed to guarantee that clinical trials sufficiently examine the differential effects of gender and racial and ethnic groups, and the NIH Revitalization Act requires advisory councils from each institute or center to prepare biannual reports describing their compliance. Mandated by the 21st Century Cures Act, inclusion statistics are reported triennially in the NIH Director’s Report.

The Office of Management and Budget sets minimum standards for race and ethnicity. Dr. Kennedy clarified that race and ethnicity are distinct concepts, and that there are currently two ethnic categories and five racial categories. She explained that an individual can identify with both an ethnic category and one or more racial categories – or choose not to disclose this information at all.

Before presenting inclusion data from NIMH funded clinical research from FYs 2016 to 2018, Dr. Kennedy noted that in FY 2016, females represented 65 percent of participants enrolled in extramural clinical research. This figure decreased to 48 percent in FYs 2017 and 2018. She explained that the large percentage of females in FY 2016 is accounted for by the Mental Health Research Network-II Study (MHRSN-II), which also resulted in a large percentage of reported “unknown” race in FY 2016 and an apparent decrease in Hispanic participation in FYs 2017 and 2018. Otherwise, the two largest racial minority groups were Black and Asian. The racial distribution of participants enrolled in intramural research remained relatively steady across the years. Female participation in intramural clinical trials was about 45%, compared to the 60% overall representation in clinical research.

Discussion

Dr. Miller expressed appreciation for the presentation of the data and commented that most grant applications he has reviewed were not compliant with NIH policy. He noted that some reviewers felt that the current policy standards are too high, and he questioned whether there are any goals or mechanisms in place for ensuring better compliance. Dr. Kennedy replied that she works directly with program officers and principal investigators (PI) to resolve problems related to inclusion. She noted that applications that do not meet inclusion criteria are flagged and barred from funding until they reach compliance. Dr. Gordon offered a correction, stating that NIH no longer bars funding for flagged applications, but rather puts a hold on the start of clinical protocols until the issues are resolved.

Dr. Pflanz was interested to know if representation is sufficient among NIH researchers. Dr. Gordon said they are working with the Office of Disparities Research to determine the current diversity of the workforce and to work towards increasing diversity.

Dr. Risch questioned if there were expectations for inclusion of Pacific Islander and Native American participants, which should be noted. He expressed concern regarding the “other” category. He said that the internal diversity of this category poses challenges for including them as a single group, and he suggested that more work is necessary to clarify goals, standards, and expectations.

Dr. Miller said that PIs who fail to meet compliance are required to provide justification for their intended representation. However, in his experience, PIs rarely attempt to defend their rationale.

Dr. Gordon pointed out that in some cases, it may be adequate to categorize certain smaller racial or ethnic groups as one, rather than attempting to see representation of various multiracial categories. Dr. Risch was concerned that a standard of “adequate” is too subjective. Dr. Gordon replied that NIH policy is not intended to require investigators to have enough power to detect main effects in every ethnic or racial group, but only to justify the distribution in the existing population study, and address issues for certain racial or ethnic groups.

Mr. Staglin wondered if the NIH has considered neurodiversity among its workforce and asked if anything can be improved in the future. He suggested that it is important for researchers to understand their participants’ experiences. Dr. Gordon said that the federal-wide standards define specific categories of workplace diversity. He added that the NIMH tries to maintain neurodiversity in its employees to ensure adequate representation. However, NIH does not consider neurodiversity in workforce development because there are limits to the definition of underrepresented groups.

Dr. Gordon thanked Dr. Kennedy and the Council members and asked for a motion to approve the reports. A motion to approve was passed.

Concept Clearances

Dr. Susan Azrin, Ph.D. and Jane Pearson, Ph.D.

Dr. Gordon explained that the public concept clearance announcements are intended to shape future funding initiatives and determine upcoming priorities. He added that concept clearances also allow the Institute to make public declarations of potential funding opportunity announcements. In the interest of time, Dr. Gordon suggested that any Council members who have non-question comments should email the presenters directly.

Reducing the Duration of Untreated Psychosis in the United States

Susan Azrin, Ph.D.

Dr. Azrin introduced the first concept, the goal of which is to remove obstacles to research on practical applications for reducing the duration of untreated psychosis (DUP) among people with first-episode psychosis. She explained that the early phase of a psychotic illness represents a critical opportunity for preventing and treating disability, consequently improving outcomes across the lifespan.

She briefly reviewed the history of NIMH initiatives to reduce DUP. NIMH has successfully supported nine projects that developed and tested practical DUP reduction strategies, including clinician training and increased screening in mental health clinics and other settings. Currently, the NIMH RAISE Early Treatment Program found that coordinated specialty care (CSC), a recovery-oriented treatment program, is more effective than traditional treatment approaches for first-episode psychosis. In addition to CSC, other promising areas for DUP reduction research include identifying, treating, and monitoring individuals at high clinical risk for psychosis; promoting CSC in school and college mental health programs; enhancing CSC referrals from clinical facilities; working with police departments to recognize psychotic symptoms; empowering family members; and using the internet to facilitate help-seeking. Dr. Azrin explained that the proposed initiative would further support pragmatic clinical trials to test practical strategies for substantially reducing DUP among people with first-episode psychosis in the United States.

Discussion

Dr. Sophia Vinogradov and Mr. Brandon Staglin, Council Discussants

Dr. Vinogradov wondered if pediatricians and primary care providers could be a valuable resource for referring individuals with psychosis to appropriate treatment options. She also pointed out that initiatives to expand education and advocacy in family members might be another way to engage individuals with psychosis. Moreover, clinicians may need more support in engaging individuals who screen positive for psychosis and guiding them toward treatment in real-world clinical settings. Finally, Dr. Vinogradov pointed out that co-occurring marijuana use can complicate clinical work with this population.

Mr. Staglin agreed that early intervention for psychosis is critical, and he expressed support for funding psychosis-related research, suggesting that Dr. Azrin give further thought to internet-based outreach and treatment programs. He cited a Yale study that found that only 8% of youth receiving first treatment have reliable access to quality special care. Consequently, he proposed that a partnership with SAMHSA or Medicare/Medicaid could improve access to specialty care and expand the number of treatment centers. By his own calculations, increasing quality specialty care access to include 75% of youth with psychosis could save the United States $260B over two decades.

Dr. Benton commented that there is a lot of data about developmental deficits in children prior to the onset of psychosis, and she suggested thinking about initiatives to identify at-risk children in primary care settings. She also expressed concern that current guidelines allow long periods of treatment with potentially ineffective medications before allowing participants to begin treatment with more responsive medications.

Dr. Everett clarified that SAMHSA’s block grants provide state funding for quality specialty care, but she pointed out that rural geography and population distribution can be significant barriers to access. She encouraged the Council to consider virtual and telemedicine treatments to increase access to quality specialty care.

Dr. Saks said that it is important to educate junior and high school students about mental disorders like psychosis in order to increase awareness of symptoms and treatment options. She said that the Gould School of Law at University of Southern California has started a club called Law Students for Better Health, which focuses on providing mental health education and advocacy on campus.

Dr. Gordon called for a motion to approve the concept. A motion to approve was passed.

Building an Evidence Base for Rapid Acting Interventions for Severe Suicide Risk

Jane Pearson, Ph.D.

Dr. Pearson began her presentation by providing context about the Prioritized Research Agenda for Suicide Prevention, which has recently funded research on Zero Suicide, a program aimed at reducing suicide events by supporting systems dedicated to improving patient safety. She said that the research currently focuses more broadly on the health care system’s interactions with suicide, and she suggested that there is a need to investigate fast-acting treatments for severe suicidal risk. Data from the SAMHSA National Survey on Drug Use and Health (NSDUH), and from the CDC suggest that in 2017 more than 700,000 people sought medical treatment after a suicide attempt. Many of these people report that they are discouraged from seeking immediate treatment for fear of involuntary commitment. She concluded by briefly reviewing some novel and existing treatment options for treatment-resistant suicidal ideation, including ketamine, neuromodulation treatment, and internet-based interventions.

Discussion

Dr. Michael Hogan and Dr. Cheryl King, Council Discussants

Dr. Hogan expressed approval of the concept, and he added that there is a need for Requests for Applications (RFAs) to stimulate interest in this area. He said that HEDIS measures of people who are discharged from inpatient treatment for suicidality who seek a follow-up visit within one week has a performance measure of only 51%, significantly lower than national HEDIS measures for other conditions. As a result, it is critical to develop more effective, suicide-specific treatments to increase patient engagement with services. He also suggested that treatment sequencing is an important area to consider. Because suicide is complex and varies on an individual basis, a combination of different treatment strategies may be necessary for successful intervention. However, Dr. Hogan added that brief interventions can also be highly effective.

Dr. King also expressed her support for this concept, as well as her belief that NIMH has the capability to catalyze research that addresses gaps in knowledge about suicide. She said that most brief interventions, which increase patients’ safety while long-term therapeutic interventions take effect, tend to focus on stabilization, evaluation, assessment, and safety planning. She continued that the brief interventions are comparable to acute care management rather than long-term treatment trajectories.

Dr. King summarized her ideas about potential evidence-based care management strategies to fill the time gap while long-term treatments begin to take effect. She suggested that investigators should lay out expectations for timing, impact, and outcomes before beginning their research. She also commented that investigators should take special care in tracking individual aspects of care management, safety planning, and repeated assessment in order to study the incremental benefits of the treatments during the study period.

Dr. Robinson Beale commented about implementing the concept in health care systems. She wondered what kind of training would be necessary and how these initiatives would be funded, adding that payors need clarity about the longevity of these interventions. Consequently, research needs to include the economic impact of particular interventions. She continued that research should also produce information that guides training and replication, as well as include clear, standardized measures of performance.

Dr. Gordon called for a motion to approve the concept. A motion to approve was passed.

Comments from Retiring Members

Dr. Druss began by thanking the Council members, and he went on to briefly review the longstanding relationship between NIMH and the area of public health. He spoke about the 1946 National Mental Health Act, which established the NIMH and has generated a long history of prevention, recovery, and cures for mental disorders. He reflected that his work with the Council afforded him the opportunity to watch scientific initiatives advance and foster change in real time, and he expressed his optimism for the future of public health. He concluded by reiterating his gratitude for his time with the Council and his fellow members.

Dr. Hogan, who had already once retired from the Council, reflected on how the Council has changed and remained the same over the last two decades. He commented that NIMH staff have continued to improve during his tenure, but he said that barriers still exist between research and service. Following the legacy of Dr. Judd, Dr. Hogan expressed concern that the Institute’s portfolio has failed to balance science research with efforts to implement that knowledge towards impactful change. He said that in the last decade there have been remarkable cases – including first-episode psychosis care – in which NIH has successfully broken the barrier between knowledge and practice, and he hoped that this trend continues. Dr. Hogan expressed his gratitude for his time with the Council and wished the remaining members good luck.

Public Comment Period

Dr. Gordon invited public comment. There were no registered public comments and no speakers stepped forward.

Adjournment

The open session of the NIMHAC meeting adjourned at 1:07 P.M.

Closed Session

The grant application review portion of the meeting was closed to the public in accordance with provisions as set forth in Section 552b(c)(4) and 552b(c)6. Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended. The closed session was set to resume at 2:00 pm.

Appendix A

Summary of Primary MH Applications Reviewed
Council: January 2019

IRG Recommendation
Category Scored # Scored Direct Cost $ Not Scored (NRFC) # Not Scored (NRFC)
Direct Cost $
Other # Other Direct Cost $ Total # Total Direct Cost $
Research 541 $789,182,772 445 $560,496,670 0 0 986 $1,349,679,442
Research Training 24 45,752,181 11 18,194,653 0 0 35 63,946,834
Career 85 $65,118,256 30 $23,786,317 0 0 115 $88,904,573
Other 0 0 0 0 0 0 0 0
Totals 650 $900,053,209 486 $602,477,640 0 $0 1,136 $1,502,530,849

Appendix B

Department of Health and Human Services
National Institutes of Health
National Institutes of Health
National Advisory Mental Health Council
(Terms end 9/30 of designated year)

Chairperson

  • Joshua A. Gordon, M.D., Ph.D.
    Director
    National Institute of Mental Health
    Bethesda, MD

Executive Secretary

  • Jean Noronha, Ph.D.
    Director
    Division of Extramural Activities
    National Institute of Mental Health
    Bethesda, MD

Members

Laura A. Almasy, Ph.D. (pending Ad Hoc)
Professor
Department of Genetics
Perelman School of Medicine
University of Pennsylvania
Philadelphia, PA
Michael F. Hogan, Ph.D. (18)
Consultant and Advisor
Hogan Health Solutions LLC
Delmar, NY
Marjorie L. Baldwin, Ph.D. (pending Ad Hoc)
Professor
Department of Economics
W. P. Carey School of Business
Arizona State University
Tempe, AZ
Lisa H. Jaycox, Ph.D. (20)
Senior Behavioral Scientist
Health Program
Rand Corporation
Arlington, VA
Tami D. Benton, M.D. (19)
Psychiatrist-in-Chief
Department of Child and Adolescent Psychiatry And Behavioral Sciences
Children’s Hospital of Philadelphia
Philadelphia, PA
Cheryl A. King, Ph.D. (21)
Director
Mary A. Rackham Institute
Professor, Department of Psychiatry and Psychology
University of Michigan
Rachel Upjohn Building
Ann Arbor, MI
Randy D. Blakely, Ph.D. (20)
Professor
Department of Biomedical Sciences
Charles E. Schmidt College of Medicine
Florida Atlantic University
Jupiter, FL
John H. Krystal, M.D. (19)
Robert L. McNeil, Jr. Professor of Translational Research
Chair, Professor of Neurobiology
Chief of Psychiatry, Yale-New Haven Hospital
Department of Psychiatry
Yale University School of Medicine
New Haven, CT
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
Gregory A. Miller, Ph.D. (20)
Professor and Chair
Department of Psychology
University of California, Los Angeles
Los Angeles, CA
Ian H. Gotlib, Ph.D. (20)
David Starr Jordan Professor and Chair
Department of Psychology
Stanford University
Stanford, CA
Yael Niv, Ph.D. (21)
Professor
Princeton Neuroscience Institute, Room 143
Department of Psychology
Princeton University
Princeton, NJ
Alan E. Greenberg, M.D., M.P.H. (20)
Professor and Chair
Department of Epidemiology and Biostatistics
School of Public Health
George Washington University
Washington, DC
Neil J. Risch, Ph.D. (21)
Director
Institute of Human Genetics
Lamond Family Foundation Distinguished Professor In Human Genetics
University of California, San Francisco
513 Parnassus Avenue
San Francisco, CA
David C. Henderson, M.D. (20)
Chair
Department of Psychiatry
Boston University School of Medicine
Boston, MA
Rhonda Robinson Beale, M.D. (19)
Senior Vice President and Chief Medical Officer
Blue Cross of Idaho
Meridian, ID
Sophia Vinogradov, M.D. (pending Ad Hoc)
Donald W. Hastings Endowed Chair
University of Minnesota Medical School
Professor and Department Head
Department of Psychiatry
Minneapolis, MN
Elyn R. Saks, J.D., Ph.D. (20)
Orrin B. Evans Professor of Law
Gould School of Law
University of Southern California
Los Angeles, CA
Brandon Staglin, M.S. (21)
Director
Marketing and Communications
One Mind Institute
Rutherford, CA
Christopher A. Walsh, M.D., Ph.D. (19)
Chief, Division of Genetics and Genomics
Boston Children’s Hospital
Bullard Professor of Pediatrics and Neurology
Harvard Medical School
Boston, MA

Ex Officio Members

Office of the Secretary, DHHS

  • Alex Azar
    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

Department of Veterans Affairs

  • Amy M. Kilbourne, Ph.D., M.P.H..
    Director
    Quality Enhancement Research Initiative
    Health Services Research & Development
    Department of Veterans Affairs, Ann Arbor
    Ann Arbor, MI

Department of Defense

  • Steven E. Pflanz, M.D.
    Air Force Director of Psychological Health
    Mental Health Branch Chief
    Air Force Medical Support Agency
    Fall Church, VA

Liaison Representative

  • Anita Everett, M.D., DFAPA
    Acting Director, Center for Mental Health Services
    Substance Abuse and Mental Services Administration
    Rockville, MD

NIMH Staff

Anji Addington
Rajini Agarwal
Alexander Agrello
Ishmael Amarreh
Phyllis Ampofo
Kathy Anderson
Paige Anderson
Victoria Arango
Jules Asher
Shelli Avenevolii
Frank Avenilla
Susan Azrin
Shaunna Bach
Crystal Barksdale
Julie Frost Bellgowan
Nick Gaiano
Marjorie Garvey
Lisa Gilotty
Miri Gitik
Nitin Gogtay
Chris Gordon
Margaret Grabb
Greg Greenwood
Adam Haim
Chantel Hampton
Wanda Harris-Lewis
Samanath Helfert
Robert Heinssein
Mi Hillafors
Meena Hiremath
Rebecca Hommer
Andrea Horvath
Cathleen Hsu
Shuang-Bao Hu
Ann Huston
Terri Jarosik
Kendall Johnson
Tamara Johnson
Andrew Jones
Jeymohan Joseph
Denise Juliano-Bult
Pat Kaplan
Tamara Kees
Ashley Kennedy
Doug Kim
Darnetta King
Megan Kinnan
Susan Koester
Stephanie Lacy

A.Beckel Mitchener
Lora Bingaman
Yancy Bodenstein
Susan Borja
J. Borzan
Toni Boswell
Linda Brady
Alicia Caffi
Holly Campbell-Rosen
Monica Carter
Mindy Chai
Zieta Charles
Mark Chavez
Deepa Chhetwel
Bo Yeon Lee
Thomas Lehner
David Leitman
Tamara Lewis Johnson
Sarah Lisanby
Bo Yeun Lee
Thomas Lehner
Jane Lin
Amber Linde
Alan Lo
David McMillen
Julie Mason
Jennifer Mehra
Doug Meinecke
Enrique Michelotti
Becky Miller
David Miller
Diana Morales
Sarah Morris
Mark Murdock
Eric Murphy
Laurie Nadler
Gretchen Navid
Anna Ordonez
Jenni Pachen
David Panchision
Maryland Pao
Jane Pearson
Michele Pearson
James Peterson
Jonathan Pollock
William Potter
Janani Prabhakar
Beverly Pringle
Diane Rausch

Jay Churchill
Rebecca Claycamp
Claire Cole
Heather Coulter
Roberto Delgado
Debra Dabney
Jamie Driscoll
Tara Dutka
Greg Farber
Jean Marc Fellows
Michele Ferrante
Hillary Flowers
Meredith Fox
Michael Freed
Bruce Reed
Eve Reider
Christian Richardson
Melba Rojas
Mary Rooney
Andrew Rossi
Jamie Rotini
Judy Rumsey
Agnes Rupp
Chris Sarampote
Rachel Scheinert
Michael Schoenbaum
Aileen Schulte
Teri Senn
Geetha Senthil
Erin Shannon
Pamela Shell
Gwen Shinko
Joel Sherrill
Janine Simmons
Dawn Smith
Michael Sirratt
David Stoff
Leandra Stubbs
Brooke Sydnor
Adam Thomas
Ashlee Van’t Veer
Aleksandra Vicentic
Clarissa Vincent
Ann Wagner
Abera Wouhib
Yong Yao
Steven Zalcman
Julia Zehr
Natalie Zeigler