NIMH Update Christopher Sarampote, NIMH 2017 AADCAP Annual Meeting Office of Training and Career Development Division of Translational Research NIMH 2017 AADCAP Annual Meeting Washington, DC

NIMH Extramural Scientific Divisions Office of Research Disparities and Global Mental Health (ORDGMH) Translational (DTR) Neuroscience & Basic Behavioral (DNBBS) Services & Interventions (DSIR) AIDS/HIV (DAR) NIMH organization and where I reside Psychopathology Tx Development Effectiveness Services Pre-Clinical

NIMH Transitions Leadership NIMH and HHS New Director: Josh Gordon, MD, PhD New Deputy Director: Shelli Avenevoli, PhD NIMH and HHS NIMH looks forward to working with the new administration NIMH contributed to NIH transition reports Dr. Collins will continue as NIH Director for an indeterminate time Dr. Gordon’s research focuses on the analysis of neural activity in mice carrying mutations of relevance to psychiatric disease. Was an associate director of the Columbia University/New York State Psychiatric Institute Adult Psychiatry Residency Program Also maintained a general psychiatric practice, caring for patients who suffer from the illnesses he studied in his lab at Columbia. Shelli Avenevoli: developmental psychologist and extramural program officer Continuation of NIMH priorities under Dr. Insel at this time, with new priorities under evaluation and development Directors’ messages page: autism, psychosocial intervention, computational neuroscience

21st Century Cures Act (Dec 2016) Non-partisan national commitment to mental health research, prevention, treatment, and recovery Key provisions for mental health treatment: Appoints directors of NIMH, NIDA, NIAAA, to SAMHSA advisory councils Encourages collaboration to ensure evidence-based practices Strengthens existing mental and behavioral health care parity legislation Includes broad provisions to assist for special populations Key provisions for mental health research: Encourages rigor and reproducibility; strengthens NIH’s ability to enforce data sharing Requires Certificates of Confidentiality for clinical research Exempts certain genomic data from Freedom of Information Act requests Signed into law December 2016 New secretary for mental health and substance abuse services in HHS: candidate Dr. Elinore McCance-Katz 

21st Century Cures Act of 2016 $4.8 Billion for NIH Innovative Research Initiatives BRAIN: Brain Research through Advancing Innovative Neurotechnologies Reprinted from Hudson, KL and Collins, FS (2017). The 21st Century Cures Act: A View from the NIH. NEJM, 376: 111-113.

NIH BRAIN Initiative Oct 2016: NIH announced third round of grants Over 100 new awards 170 investigators working at 60 institutions Totaling more than $70m Nearly doubles FY2016 NIH investment in BRAIN 21st Century Cures Act authorizes funding for 10 more years

Adolescent Brain Cognitive Development (ABCD) Study www.abcdstudy.org Multi-site, landmark study on brain development and child health led by NIDA, NIAAA, NCI Will recruit 10,000 healthy children and follow into adulthood

NIMH Budget Updates Approximately $980M for RPGs, $38M for research training, $172M IM, $73M research centers

Overview of Current NIMH Priorities Strategic Objectives Experimental Therapeutics Approach to Interventions RDoC and Data-Driven Approaches Suicide Prevention Understanding Neural Circuits Computational Psychiatry

NIMH and Clinical Neuroscience To wrest from nature the secrets which have perplexed philosophers in all ages, to track their sources the cause of disease, to correlate the vast stores of knowledge, that they may be quickly available for prevention and cure of disease – these are our ambitions. - Sir William Osler Since Dr. Insel’s arrival at NIMH, the institute has increasingly focused on underlying brain circuitry that gives rise to mental illness, so that we might leverage the findings from basic neuroscience to understand etiology of disease, risk factors, and identify new treatments.

NIMH Research Priorities Mission: To transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure Strategic Objective 1: Define the mechanisms of complex behaviors Strategic Objective 2: Chart mental illness trajectories to determine when, where, and how to intervene Strategic Objective 3: Strive for prevention and cures Strategic Objective 4: Strengthen the public health impact of NIMH-supported research

Experimental Therapeutics Approach to Interventions as tool to validate or engage the target Target Engagement informs “go/”no-go” decision Clinical Trial value optimized regardless of clinical effect

Clinical Trial Pipeline: Phase of Intervention Development Experimental Therapeutics Clinical Trials Funding Opportunity Announcements (FOAs) Clinical Trial Pipeline: Phase of Intervention Development First in Human Exploratory Experimental Therapeutics Confirmatory Efficacy Effectiveness Trials for Treatment, Preventive, and Services Interventions First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01) Confirmatory Efficacy Trials of Non-Pharmacological Interventions for Mental Disorders (R01) Pilot Effectiveness Trials for Treatment, Preventive and Serivices Interventions (R34) Early Stage Testing of Pharmacologic or Device-based Interventions for the Treatment of Mental Disorders (R61/R33, R33) Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01, Collaborative R01) Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33, R33) https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml

Research Domain Criteria (RDoC) Dimensional approach to psychopathology that integrates elements of biology and psychology Template for psychopathology research (NOT a classification system) Agnostic to diagnosis, but focused on narrowly defined impairments of psychiatric clinical importance Take home messages This is not a classification system Agnostic to diagnosis Not all grants need to be RDoC grants

Research Domain Criteria (RDoC) Over 40 grants funded under RDoC FOAS since 2011 Resources NIMH RDoC webpage RDoC monthly “Office Hours” RDoC Webinar Series RDoC-influenced Courses

Suicide Prevention

Behavioral Neuroscience: Understanding Neural Circuitry Etiological Factors (genes, experience) Molecular or Structural Pathology Circuit Dysfunction Neuro-functional Disability Understanding brain function and dysfunction Characterize molecular identity, anatomy, and activity patterns in a cell-type specific manner Monitor and manipulate circuits for improved function Drive and inhibit circuits with precise behavioral effects.

Computational Psychiatry

Research Training and Career Development NIMH offers training grants across the career timeline Three ways NIMH provides training funds Directly from NIH (individual awards: F, K) From an academic institution with an NIH-supported training program (T32) From an administrative supplement to an existing NIH grant (diversity reentry, MD) NIMH Training Success Rates: F: 20%, Mentored K: 38%, K99: 23%

Specific Training Opportunities F30 NRSA Individual Predoctoral MD/PhD or other Dual-Doctoral Degree Fellowship Administrative Supplements for Physician Scientists NIMH Research Education Programs Supporting Psychiatry Residents (R25) NIMH Mentoring Networks for Mental Health Research (R25)

Career Development Program in Emergency Care Research (K12) Areas of interest: suicide prevention; management of psychiatric emergencies in ED settings; post-traumatic psychopathology risk detection and intervention; and mental health services in ED settings. Recruitment of the second, and final, cohort of K12 scholars will open later in 2017 Indiana Emergency Care Research (Indiana EMCARE) Training Program Indiana University School of Medicine Program Directors: Jeffrey A. Kline, MD and Kurt Kroenke, MD Oregon Emergency Care Research Multidisciplinary Training Program Oregon Health & Science University Program Directors:  Craig D. Newgard, MD, MPH and Cynthia D. Morris, PhD, MPH Vanderbilt Emergency Care Research Training Program Vanderbilt University Program Directors:  Alan B. Storrow, MD and Thomas J. Wang, MD NIMH Contact: Lauren Hill, PhD

NIH Loan Repayment Program Repay up to $35K annually of a researcher’s qualified educational debt Renewable https://www.lrp.nih.gov

www.nimh.nih.gov Research = Hope