# 2019 Spring Inside NIMH

## Welcome

Welcome to the latest edition of *Inside NIMH* ! We publish *Inside NIMH* in conjunction with each meeting of the National Advisory Mental Health Council (NAMHC), which advises the Secretary of Health and Human Services (HHS), the Director of the National Institutes of Health (NIH), and the Director of NIMH on policies and activities relating to the conduct and support of mental health research, research training, and other programs of the Institute. Check out our website for regular updates on timely topics at NIMH. I hope you find this information interesting and helpful. Please let us know if you have questions or comments on this Spring 2019 edition.

Sincerely,Joshua A. Gordon, M.D., Ph.D.Director, National Institute of Mental Health

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## NIMH Director’s Updates

Happy 70th birthday, NIMH! On April 15, 1949, NIMH was formally established ** – it was one of the first four NIH institutes. Over the past 70 years, NIMH-supported researchers have made tremendous discoveries to advance the field of mental health. In this edition of *Inside NIMH*, we continue to celebrate recent therapeutic advances, plan for the future, and note key developments across NIH.

### News to Know

- Transformative Therapeutics:  In March 2019, the Food and Drug Administration (FDA) approved two new promising neurotherapeutic drugs.	   - Esketamine:  Ketamine, an anesthetic that was approved by the FDA in 1970, is emerging as a potential rapid onset intervention for acute suicide risk and treatment-resistant depression. Ketamine is associated with rapid–within minutes to hours–decrease in depressive symptoms and suicidal thoughts. The  FDA recently approved **  Spravato TM , an esketamine (a form of ketamine) nasal spray that should be taken in conjunction with an oral antidepressant, for treatment-resistant depression in adults. This is the first truly novel FDA-approved antidepressant medication in decades (followed quickly by Brexanolone, see next bullet). The makers of Spravato TM  are also conducting  clinical trials **  of intranasal esketamine in participants at imminent risk for suicide. NIMH-supported intramural and extramural research helped lay the foundation for the development of this drug.
  - Brexanolone:  Approximately 1 in 9 women in the United States experiences symptoms of postpartum depression, according to the  Centers for Disease Control and Prevention  ** (CDC). The FDA recently approved  brexanolone ** , an analog of the endogenous human hormone allopregnanolone and the first drug specifically designed to treat postpartum depression. FDA approval represents the final phase of a  bench-to-bedside journey  for this drug — a journey that began in the NIMH Intramural Research Program (IRP).
- NIMH Strategic Planning Efforts:  NIMH uses its  Strategic Plan for Research  to guide the Institute towards achieving its mission. To keep pace with scientific progress, the plan is updated every five years. NIMH leadership and staff are currently working to draft the 2020 NIMH Strategic Plan for Research. NIMH plans to provide a draft to NAMHC members for review and discussion at the 2019 September Council meeting. NIMH will then publish a Request for Information via the Federal Register to solicit public feedback, and the Institute will publish the new NIMH Strategic Plan for Research in 2020.
- Interagency Autism Coordinating Committee (IACC):  The  IACC **  met on April 17, 2019. Presentations included a tutorial on the CDC’s new Autism Data Visualization Platform, an update on disability policies from the Federal Communications Commission, as well as a presentation of research to address employment for people with autism spectrum disorder (ASD). On May 21, 2019, the IACC held a  workshop **  addressing the mental health needs of people on the autism spectrum. The workshop highlighted research on anxiety, depression, suicide, and aggressive and self-injurious behaviors in ASD.
- NIH-Wide Initiatives:    - Adolescent Brain Cognitive Development (ABCD) Study:  The ABCD study is the largest long-term study of brain development and child health in the United States. On April 2, 2019,  NIH released **  the comprehensive baseline dataset from the  ABCD study   **  – available on the  NIMH Data Archive ** . Approximately 100 terabytes of data obtained from the full participant cohort (11,878 youth and their families) can now be accessed by scientists worldwide to conduct research on the many factors that influence brain, cognitive, social, and emotional development.
  - *All of Us* Research Program:  On March 14, 2019, the  *All of Us* Research Program **  launched a  Speaker Series **  in partnership with the National Library of Medicine. In the inaugural talk, NIH Director Francis Collins, M.D. discussed the importance of  All of Us , noted how far the research program has come, provided a preview of the Program’s future, and answered questions from viewers. On May 6, 2019, one year following the launch of the  All of Us  Research Program, NIH hosted a  mini-symposium **  to discuss what has been learned about building an engaged and diverse participant community, and its potential for scientific impact.
  - Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative®:  At the fifth annual  BRAIN Investigators Meeting **  on April 11-13, 2019, over 1,500 BRAIN Initiative awardees, representatives, and investigators joined staff and leadership from the contributing federal agencies, members of Congress, members of the media, and the interested public to advance the understanding of the brain and nervous system. The BRAIN Initiative  Multi-Council Working Group **  met on February 12, 2019 and May 16, 2019. Ongoing meetings of the  Advisory Committee to the NIH Director BRAIN Initiative Working Group 2.0  ** , and its  BRAIN 2.0 Neuroethics Subgroup (BNS) ** , as well as  public feedback  ** , continue to guide updates to  BRAIN 2025: A Scientific Vision ** . On January 23, 2019, the BNS conducted a portfolio review and held a  public workshop  **  on neuroethical issues posed by BRAIN Initiative research. The BNS welcomes  comments   from the public on draft findings and analysis detailed in a  Neuroethics Roadmap ** .
  - Helping to End Addiction Long-term (HEAL) Initiative:  The  NIH HEAL Initiative **  is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. On February 26, 2019, NIH announced the appointment of  Rebecca Baker, Ph.D. ** , as Director of the NIH HEAL Initiative. On March 5, 2019, NIH announced the formation of the  HEAL Partnership Committee ** , a subgroup of the  HEAL Multi-Disciplinary Working Group ** , to guide data sharing and information collection efforts.
- NIH Leadership News    - On February 14, 2019, NIH named  Noni H. Byrnes, Ph.D. **  Director of the  NIH Center for Scientific Review (CSR) ** . Dr. Byrnes has been with CSR since 2000 and served as Acting Director of CSR since May 2018.
  - On April 5, 2019, Norman “Ned” Sharpless, M.D. was  named **  Acting FDA Commissioner. Dr. Sharpless was the Director of the National Cancer Institute (NCI) at NIH.  Douglas R. Lowy, M.D. **  is currently serving as Acting NCI Director. Dr. Lowy previously served as Acting Director between April 2015 and October 2017 and has held the NCI Deputy Director position since July 2010.
  - On May 2, 2019, NIH announced the selection of  Debara L. Tucci, M.D., M.S., M.B.A. **  to lead the  National Institute on Deafness and Other Communication Disorders (NIDCD) **  as its new Director. Dr. Tucci is currently a professor of surgery and the Director of the cochlear implant program at Duke University in Durham, North Carolina. She is expected to join NIH on September 3, 2019.

### Budget Overview

- Fiscal Year (FY) 2019 Budget :  On September 28, 2018, President Trump signed the Appropriations Act of 2019 (Public Law No. 115-245) providing funds through September 30, 2019. The law provides $1.870 billion to NIMH (amount includes 21st Century Cures funding), representing a 6.6 percent increase over the FY 2018 appropriation. NIMH anticipates awarding more than 600 new and competing research project grants (RPGs) in FY 2019, with an estimated success rate of 26 percent, as shown in Figure 1 below.  	 	                    NIMH Applications, Awards, and Success Rates for Research Project Grants                  Fiscal YearApplicationsDirect AwardsCures AwardsSuccess Rate20142830548019201524805070202016256858702320172735571021201827015892323201926746773026